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Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson Disease (STEADY-PD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00909545
Recruitment Status : Completed
First Posted : May 28, 2009
Results First Posted : April 17, 2013
Last Update Posted : April 17, 2013
Sponsor:
Collaborators:
Michael J. Fox Foundation for Parkinson's Research
Northwestern University Dixon Fund
The Parkinson Study Group
Information provided by (Responsible Party):
Tanya Simuni, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Parkinson Disease
Interventions Drug: Isradipine CR 5mg
Drug: Isradipine CR 10mg
Drug: Isradipine CR 20mg
Drug: Placebo
Enrollment 99
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 15-20mg/Day
Hide Arm/Group Description 4 Placebo to Match (PTM) tablets once daily 1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily 2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily 3-4 Dynacirc CR 5mg tablets once daily
Period Title: Overall Study
Started 26 23 26 24
Completed 25 22 25 19
Not Completed 1 1 1 5
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day Total
Hide Arm/Group Description 4 Placebo to Match (PTM) tablets once daily 1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily 2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily 4 Dynacirc CR 5mg tablets once daily Total of all reporting groups
Overall Number of Baseline Participants 26 23 26 24 99
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 23 participants 26 participants 24 participants 99 participants
60.2  (10.1) 57.7  (8.3) 58.5  (11.6) 59.8  (8.9) 59.1  (9.8)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 23 participants 26 participants 24 participants 99 participants
Between 30 and 65 years 17 18 18 19 72
>=65 years 9 5 8 5 27
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 23 participants 26 participants 24 participants 99 participants
Female
5
  19.2%
8
  34.8%
9
  34.6%
8
  33.3%
30
  30.3%
Male
21
  80.8%
15
  65.2%
17
  65.4%
16
  66.7%
69
  69.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 23 participants 26 participants 24 participants 99 participants
White 25 22 22 22 91
Other race 1 1 4 2 8
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 23 participants 26 participants 24 participants 99 participants
United States 24 21 24 21 90
Canada 2 2 2 3 9
Unified Parkinson's Disease Rating Scale (UPDRS) Total   [1] 
Mean (Standard Deviation)
Unit of measure:  Unit of UPDRS scales
Number Analyzed 26 participants 23 participants 26 participants 24 participants 99 participants
25.46  (9.39) 26.43  (9.69) 23.65  (9.97) 24.67  (10.77) 25.0  (9.9)
[1]
Measure Description: Higher score indicates more severe disability.
Unified Parkinson's Disease Rating Scale (UPDRS) Mental   [1] 
Mean (Standard Deviation)
Unit of measure:  Unit of UPDRS scales
Number Analyzed 26 participants 23 participants 26 participants 24 participants 99 participants
0.65  (1.06) 1.30  (1.79) 0.65  (0.98) 0.96  (1.12) 0.9  (1.3)
[1]
Measure Description: Higher score indicates more severe disability.
Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL)   [1] 
Mean (Standard Deviation)
Unit of measure:  Unit of UPDRS scales
Number Analyzed 26 participants 23 participants 26 participants 24 participants 99 participants
5.85  (2.98) 5.83  (3.02) 6.15  (3.03) 6.58  (3.03) 6.1  (3.0)
[1]
Measure Description: Higher score indicates more severe disability.
Unified Parkinson's Disease Rating Scale (UPDRS) Motor   [1] 
Mean (Standard Deviation)
Unit of measure:  Unit of UPDRS scales
Number Analyzed 26 participants 23 participants 26 participants 24 participants 99 participants
18.96  (7.27) 19.30  (8.02) 16.85  (7.88) 17.13  (8.26) 18.0  (7.8)
[1]
Measure Description: Higher score indicates more severe disability.
Hoehn & Yahr Scale   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 23 participants 26 participants 24 participants 99 participants
H/Y Stage: 1 7 4 8 11 30
H/Y Stage: 1.5 2 3 0 1 6
H/Y Stage: 2 16 16 18 11 61
H/Y Stage: 2.5 1 0 0 1 2
[1]
Measure Description: Higher stage indicates more severe disability.
Modified Schwab & England Independence Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage scale
Number Analyzed 26 participants 23 participants 26 participants 24 participants 99 participants
93.08  (5.11) 93.48  (4.632) 93.08  (5.11) 91.04  (5.10) 92.0  (5.0)
[1]
Measure Description: Higher score indicates higher independence.
Montreal Cognitive Assessment   [1] 
Mean (Standard Deviation)
Unit of measure:  Unit of MoCA
Number Analyzed 26 participants 23 participants 26 participants 24 participants 99 participants
26.96  (2.58) 27.96  (1.97) 26.92  (2.36) 27.79  (1.89) 27.4  (2.2)
[1]
Measure Description: Lower score indicates more severe disability.
PD Qualify of Life Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Unit of PDQ-39
Number Analyzed 26 participants 23 participants 26 participants 24 participants 99 participants
10.28  (8.55) 9.69  (6.88) 8.39  (5.82) 10.45  (8.06) 9.7  (2.3)
[1]
Measure Description: Higher score indicates higher disability.
Vital Signs: Systolic  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 26 participants 23 participants 26 participants 24 participants 99 participants
Standing 130.0  (18.12) 127.3  (17.03) 130.4  (17.76) 125.8  (11.96) 128.4  (16.3)
Supine 130.9  (16.04) 128.5  (13.60) 131.3  (19.00) 129.1  (13.69) 130.0  (15.6)
Vital Signs: Diastolic  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 26 participants 23 participants 26 participants 24 participants 99 participants
Standing 83.73  (12.74) 84.43  (12.22) 80.04  (9.73) 81.29  (11.02) 82.3  (11.4)
Supine 80.69  (11.34) 79.22  (9.50) 76.88  (10.95) 79.63  (10.43) 79.1  (10.5)
Vital Signs: Pulse  
Mean (Standard Deviation)
Unit of measure:  Beats per minute
Number Analyzed 26 participants 23 participants 26 participants 24 participants 99 participants
Standing 72.92  (11.90) 77.35  (10.70) 75.50  (12.27) 72.33  (11.43) 74.5  (11.6)
Supine 68.00  (10.63) 67.43  (10.28) 67.08  (8.39) 66.33  (9.71) 67.2  (9.6)
1.Primary Outcome
Title Tolerability of the Three Dosages(5mg, 10mg and 20mg) of Isradipine CR.
Hide Description Tolerability will be judged by the proportion of subjects enrolled in a dosage group able to complete the 12 month study or to the time of initiation of dopaminergic therapy on their original assigned dosage. Tolerability of each active arm will be compared to placebo group.
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Measure Type: Number
Unit of Measure: participants
25 19 19 9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 5mg/Day
Comments The tolerability of 5mg/day dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher’s exact tests. No adjustment will be made for multiple comparisons in these analyses.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1383
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.19
Confidence Interval (2-Sided) 95%
0.0196 to 1.8411
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.1587
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 10mg/Day
Comments The tolerability of 10mg/day dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher’s exact tests. No adjustment will be made for multiple comparisons in these analyses.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0248
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.1086
Confidence Interval (2-Sided) 95%
0.0123 to 0.9591
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1114
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 20mg/Day
Comments The tolerability of 20mg/day dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.024
Confidence Interval (2-Sided) 95%
0.0028 to 0.2087
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.1035
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Efficacy: Change in Unified Parkinson's Disease Rating Scale (UPDRS)
Hide Description Outcome is defined as change in total Unified Parkinson's Disease Rating Scale (UPDRS) between the baseline visit and month 12 or the time to require dopaminergic therapy (last visit before subject goes on dopaminergic therapy), whichever occurs first. The UPDRS score has 4 components. Part I assesses mentation; Part II assesses activities of daily living; Part III assesses motor abilities; Part IV assesses complications of therapy. A total of 44 items are included in Parts I-III. Each item will receive a score ranging from 0 to 4 where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Part IV contains 11 items, 4 of these items are scored 0-4 in the same manner, and 7 are scored 0-1, with 0 indicating the absence of impairment and 1 indicating the presence of impairment. Total UPDRS score represents the sum of these items in Parts I-IV. A total of 199 points are possible. 199 represents the worst (total) disability), 0--no disability.
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Participants are 99 subjects with early Parkinson disease not requiring dopaminergic therapy.
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 15-20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
3-4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
7.40  (1.39) 7.44  (1.48) 6.30  (1.39) 5.40  (1.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 5mg/Day
Comments Change in UPDRS total score of Isradipine CR 5mg/day arm is compared to placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9834
Comments P-values for efficacy outcomes will be one-sided test with alpha = 0.05
Method ANCOVA
Comments Analysis of covariance is used, with terms representing assigned treatment group and baseline value of the measure in the model.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-3.99 to 4.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.03
Estimation Comments Least square mean(standard error) and 95% confidence intervals of the difference between Isradipine CR 5mg and placebo groups is estimated.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 10mg/Day
Comments Change in UPDRS total score of Isradipine CR 10mg/day arm is compared to placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5761
Comments P-values for efficacy outcomes will be one-sided test with alpha = 0.05
Method ANCOVA
Comments Analysis of covariance is used, with terms representing assigned treatment group and baseline value of the measure in the model.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.10
Confidence Interval (2-Sided) 95%
-5.01 to 2.80
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.97
Estimation Comments Least square mean(standard error) and 95% confidence intervals of the difference between Isradipine CR 10mg and placebo groups is estimated.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 15-20mg/Day
Comments Change in UPDRS total score of Isradipine CR 20mg/day arm is compared to placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.322
Comments P-values for efficacy outcomes will be one-sided test with alpha = 0.05
Method ANCOVA
Comments Analysis of covariance is used, with terms representing assigned treatment group and baseline value of the measure in the model
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.00
Confidence Interval (2-Sided) 95%
-5.98 to 1.99
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.01
Estimation Comments Least square mean(standard error) and 95% confidence intervals of the difference between Isradipine CR 20mg and placebo groups is estimated.
3.Secondary Outcome
Title Efficacy: Change in Mental Subscales of the Unified Parkinson's Disease Rating Scale
Hide Description The outcome is defined as change in Mental subscale of Unified Parkinson's Disease Rating Scale(UPDRS Part I) between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. UPDRS Part I: Mentation, behavior and mood, consisting of 4 questions answered on a 0-4 point scale where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total score represents the sum of these 4 questions. A greater increase in score indicates a greater increase in disability. A total of 16 points are possible. 16 represents the worst (total) disability), 0--no disability.
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were used in primary and secondary outcome analyses
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.30  (0.26) 0.76  (0.28) 0.30  (0.26) 0.03  (0.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 5mg/Day
Comments Change in Mental UPDRS subscale of Isradipine CR 5mg/day arm is compared to placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2324
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.46
Confidence Interval (2-Sided) 95%
-0.30 to 1.22
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.38
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 10mg/Day
Comments Change in Mental UPDRS subscale of Isradipine CR 10mg/day arm is compared to placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-0.73 to 0.73
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.37
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 20mg/Day
Comments Change in Mental UPDRS subscale of Isradipine CR 20mg/day arm is compared to placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4675
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.27
Confidence Interval (2-Sided) 95%
-1.02 to 0.47
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.37
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Efficacy: Change in Activities of Daily Living(ADL) Subscale of the Unified Parkinson's Disease Rating Scale
Hide Description The outcome is defined as change in ADL subscale of the Unified Parkinson's Disease Rating Scale(UPDRS Part II) between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. UPDRS Part II: Activities of Daily Living in the week prior to the designated visit, consisting of 13 questions answered on a 0-4 point scale where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total Part II score represents the sum of these 13 questions. A greater increase in score indicates a greater increase in disability. A total of 52 points are possible. 52 represents the worst (total) disability), 0--no disability
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in the primary and secondary outcome analyses
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.60  (0.56) 3.20  (0.60) 2.09  (0.56) 1.86  (0.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 5mg/Day
Comments Change in ADL UPDRS subscale of Isradipine CR 5mg/day arm is compared to placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4648
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.60
Confidence Interval (2-Sided) 95%
-1.03 to 2.23
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.82
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 10mg/Day
Comments Change in ADL UPDRS subscale of Isradipine CR 10mg/day arm is compared to placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.525
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.51
Confidence Interval (2-Sided) 95%
-2.09 to 1.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.80
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 20mg/Day
Comments Change in ADL UPDRS subscale of Isradipine CR 20mg/day arm is compared to placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3674
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.74
Confidence Interval (2-Sided) 95%
-2.36 to 0.88
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.81
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Efficacy: Change in Motor Subscale of the Unified Parkinson's Disease Rating Scale
Hide Description The outcome is defined as change in Motor subscale of the Unified Parkinson's Disease Rating Scale(UPDRS Part III) between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. UPDRS Part III: motor abilities at the time of the visit, consisting of 27 items (including 13 general questions and 14 sub-questions) each answered on a 0-4 point scale where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total Part III score represents the sum of these 27 items. A total of 108 points are possible. 108 represents the worst (total) disability), 0--no disability.
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in primary and secondary outcome analyses
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
4.32  (1.03) 3.49  (1.09) 3.91  (1.03) 3.69  (1.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 5mg/Day
Comments Change in Motor UPDRS subscale of Isradipine CR 5mg/day arm is compared to placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.579
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.83
Confidence Interval (2-Sided) 95%
-3.80 to 2.14
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.50
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 10mg/Day
Comments Change in Motor UPDRS subscale of Isradipine CR 10mg/day arm is compared to placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7778
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.41
Confidence Interval (2-Sided) 95%
-3.30 to 2.48
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.46
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 20mg/Day
Comments Change in Motor UPDRS subscale of Isradipine CR 20mg/day arm is compared to placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.669
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.64
Confidence Interval (2-Sided) 95%
-3.58 to 2.31
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.48
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Efficacy: Change in Modified Hoehn & Yahr Scale
Hide Description The Modified Hoehn & Yahr Scale is an 8-level Parkinson's disease staging instrument. The outcome is defined as change in Modified Hoehn & Yahr Scale between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. A greater increase in stage indicates a greater increase in disability. Stage ranges from 0-5 (also including 1.5 and 2.5) with 0 indicating no disability and 5 indicating maximum disability.
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in primary and secondary outcome analyses
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.27  (0.08) 0.22  (0.08) 0.12  (0.08) 0.11  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 5mg/Day
Comments Change in Modified Hoehn & Yahr Scale of Isradipine CR 5mg/day arm is compared to placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6677
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.27 to 0.17
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 10mg/Day
Comments Change in Modified Hoehn & Yahr Scale of Isradipine CR 10mg/day arm is compared to placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1755
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.15
Confidence Interval (2-Sided) 95%
-0.36 to 0.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 20mg/Day
Comments Change in Modified Hoehn & Yahr Scale of Isradipine CR 20mg/day arm is compared to placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1463
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.16
Confidence Interval (2-Sided) 95%
-0.38 to 0.06
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Efficacy: Change in Modified Schwab & England Independence Scale
Hide Description The Schwab & England scale is an investigator and subject assessment of the subject's level of independence at all scheduled study visits. The subject will be scored on a percentage scale reflective of his/her ability to perform acts of daily living in relation to what he/she did before Parkinson's disease appeared. The outcome is defined as change in Schwab & England Independence Scale between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. Higher decrease in score indicates higher disability. Score ranges from 100% (complete independence) to 0% (total disability).
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in primary and secondary outcome analyses
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-5.04  (0.96) -5.56  (1.02) -3.69  (0.96) -3.76  (1.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 5mg/Day
Comments Change in Modified Schwab & England Independence Scale of Isradipine CR 5mg/day arm is compared to placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7111
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.52
Confidence Interval (2-Sided) 95%
-3.30 to 2.26
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.40
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 10mg/Day
Comments Change in Modified Schwab & England Independence Scale of Isradipine CR 10mg/day arm is compared to placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3237
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.35
Confidence Interval (2-Sided) 95%
-1.35 to 4.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.36
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 20mg/Day
Comments Change in Modified Schwab & England Independence Scale of Isradipine CR 20mg/day arm is compared to placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3658
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.27
Confidence Interval (2-Sided) 95%
-1.51 to 4.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.40
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Efficacy: Change in Beck Depression Inventory II (BDI-II)
Hide Description The Beck Depression Inventory (BDI) is a validated self-reported 21-item depression scale that was tested and validated as a reliable instrument for screening for depression in PD. The outcome is defined as change in BDI-II between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. Total BDI score represents the sum of these 21-items. A higher change in score indicates a greater increase in disability. Total score of 0-13 is considered minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in primary and secondary outcome analyses
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.52  (0.93) 1.99  (0.93) 0.11  (0.98) 1.50  (0.95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 5mg/Day
Comments Change in BDI-II of Isradipine CR 5mg/day arm is compared to placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0608
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.50
Confidence Interval (2-Sided) 95%
-0.12 to 5.13
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.32
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 10mg/Day
Comments Change in BDI-II of Isradipine CR 10mg/day arm is compared to placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6445
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.63
Confidence Interval (2-Sided) 95%
-2.07 to 3.33
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.36
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 20mg/Day
Comments Change in BDI-II of Isradipine CR 20mg/day arm is compared to placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1336
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.02
Confidence Interval (2-Sided) 95%
-0.63 to 4.67
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.52
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Efficacy: Change in Montreal Cognitive Assessment
Hide Description The Montreal Cognitive Assessment(MoCA) is a brief 30-point screening instrument that was developed and validated to identify subjects with mild cognitive impairment. The outcome is defined as change in MoCA between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. Total MoCA score represents the sum of these 30-points, with a lower score indicating greater cognitive impairment. 30 is the maximum score, with a score of 26 or higher considered normal and below 26 indicative of Mild Cognitive Impairment.
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in primary and secondary outcome analyses
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.58  (0.40) 0.06  (0.38) 0.11  (0.41) 0.36  (0.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 5mg/Day
Comments Change in Montreal Cognitive Assessment of Isradipine CR 5mg/day arm is compared to placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3533
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.52
Confidence Interval (2-Sided) 95%
-1.64 to 0.59
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.56
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 10mg/Day
Comments Change in Montreal Cognitive Assessment of Isradipine CR 10mg/day arm is compared to placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4045
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.47
Confidence Interval (2-Sided) 95%
-1.59 to 0.65
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.56
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 20mg/Day
Comments Change in Montreal Cognitive Assessment of Isradipine CR 20mg/day arm is compared to placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7049
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-1.36 to 0.92
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.57
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Efficacy: Change in Parkinson Disease Quality of Life Questionnaire-39(PDQ-39)
Hide Description The PD Quality of Life Scale(PDQ-39) asks the subject to evaluate how Parkinson disease has affected their health and overall quality of life at that point in time. The total quality of life scale includes subscales relating to social role, self-image/sexuality, sleep, outlook, physical function and urinary function. The outcome is defined as change in PDQ-39 between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. It is scored on a scale of zero to 100, with lower scores indicating better health and higher scores more severe disability.
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in primary and secondary outcome analyses
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.28  (1.28) 3.47  (1.27) 3.00  (1.35) 3.35  (1.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 5mg/Day
Comments Change in PDQ-39 of Isradipine CR 5mg/day arm is compared to placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2278
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.19
Confidence Interval (2-Sided) 95%
-1.40 to 5.79
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.80
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 10mg/Day
Comments Change in PDQ-39 of Isradipine CR 5mg/day arm is compared to placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.356
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.72
Confidence Interval (2-Sided) 95%
-1.97 to 5.42
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.86
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 20mg/Day
Comments Change in PDQ-39 of Isradipine CR 20mg/day arm is compared to placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2600
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.07
Confidence Interval (2-Sided) 95%
-1.56 to 5.71
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.83
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Vital Signs: Change in Systolic Standing
Hide Description [Not Specified]
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-4.77  (2.49) -9.85  (2.71) -7.75  (2.60) -6.30  (2.94)
12.Secondary Outcome
Title Vital Signs: Change in Systolic Supine
Hide Description [Not Specified]
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-2.45  (2.25) -8.59  (2.45) -6.45  (2.34) -7.01  (2.65)
13.Secondary Outcome
Title Vital Signs: Change in Diastolic Standing
Hide Description [Not Specified]
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-0.38  (1.44) -4.20  (1.57) -5.14  (1.50) -4.34  (1.69)
14.Secondary Outcome
Title Vital Signs: Change in Diastolic Supine
Hide Description [Not Specified]
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
0.09  (1.27) -2.79  (1.38) -4.54  (1.32) -3.63  (1.49)
15.Secondary Outcome
Title Vital Signs: Change in Pulse Standing
Hide Description [Not Specified]
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Least Squares Mean (Standard Error)
Unit of Measure: beats per minute
-0.08  (1.89) -2.98  (2.07) -2.29  (1.97) -1.21  (2.23)
16.Secondary Outcome
Title Vital Signs: Change in Pulse Supine
Hide Description [Not Specified]
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Least Squares Mean (Standard Error)
Unit of Measure: beats per minute
-0.42  (1.55) -0.71  (1.69) -0.52  (1.62) 0.18  (1.83)
17.Secondary Outcome
Title Common Adverse Events: Oedema Peripheral
Hide Description General disorders and administration site conditions. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects.
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Measure Type: Number
Unit of Measure: participants
1 4 10 16
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 5mg/Day
Comments The analyses is to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Oedema Peripheral.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1384
Comments The analysis of common AE of each active dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher’s exact tests. No adjustment will be made for multiple comparisons in these analyses.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.2632
Confidence Interval (2-Sided) 95%
0.5432 to 50.9977
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.159
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 10mg/Day
Comments Fisher’s exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Oedema Peripheral.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments The analysis of common AE of each active dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher’s exact tests. No adjustment will be made for multiple comparisons in these analyses.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 15.6250
Confidence Interval (2-Sided) 95%
1.8214 to 134.0403
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.097
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 20mg/Day
Comments Fisher’s exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Oedema Peripheral.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments The analysis of common AE of each active dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 50.0000
Confidence Interval (2-Sided) 95%
5.7004 to 438.5694
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.108
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Common Adverse Events: Dizziness
Hide Description Nervous system disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Measure Type: Number
Unit of Measure: participants
7 5 6 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 5mg/Day
Comments one-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dizziness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7735
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.7540
Confidence Interval (2-Sided) 95%
0.2022 to 2.8120
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.6715
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 10mg/Day
Comments one-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dizziness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7385
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.8143
Confidence Interval (2-Sided) 95%
0.2314 to 2.8658
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.6419
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 20mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dizziness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6823
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.9048
Confidence Interval (2-Sided) 95%
0.2549 to 3.2112
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.6463
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Common Adverse Events: Nasopharyngitis
Hide Description Infections and infestations. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Measure Type: Number
Unit of Measure: participants
2 4 7 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 5mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nasopharyngitis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2756
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.5263
Confidence Interval (2-Sided) 95%
0.4172 to 15.2975
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.9188
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 10mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nasopharyngitis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.4211
Confidence Interval (2-Sided) 95%
0.8217 to 23.7875
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.8584
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 20mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nasopharyngitis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2953
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.4000
Confidence Interval (2-Sided) 95%
0.3975 to 14.4919
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.9174
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Common Adverse Events: Headache
Hide Description Nervous System disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Measure Type: Number
Unit of Measure: participants
3 3 6 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 5mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Headache.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6049
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.1500
Confidence Interval (2-Sided) 95%
0.2082 to 6.3508
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.8719
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 10mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Headache.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2327
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.3000
Confidence Interval (2-Sided) 95%
0.5081 to 10.4105
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7704
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 20mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Headache.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4534
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.5333
Confidence Interval (2-Sided) 95%
0.3057 to 7.6897
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.8227
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Common Adverse Events: Constipation
Hide Description Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Measure Type: Number
Unit of Measure: participants
3 2 3 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 5mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Constipation.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7852
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.7302
Confidence Interval (2-Sided) 95%
0.1109 to 4.8065
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.9616
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 10mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Constipation.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.666
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.0000
Confidence Interval (2-Sided) 95%
0.1824 to 5.4820
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.8681
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 20mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Constipation.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4534
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.5333
Confidence Interval (2-Sided) 95%
0.3057 to 7.6897
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.8227
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Common Adverse Events: Fatigue
Hide Description General Disorders and Administration Site Conditions. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Measure Type: Number
Unit of Measure: participants
2 1 3 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 5mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Fatigue.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8589
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.5455
Confidence Interval (2-Sided) 95%
0.0462 to 6.4433
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.2596
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 10mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Fatigue.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.5652
Confidence Interval (2-Sided) 95%
0.2392 to 10.2410
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.9584
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 20mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Fatigue.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4609
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.7143
Confidence Interval (2-Sided) 95%
0.2609 to 11.2639
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.9605
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Common Adverse Events: Nausea
Hide Description Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Measure Type: Number
Unit of Measure: participants
3 2 1 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 5mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nausea.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7852
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.7302
Confidence Interval (2-Sided) 95%
0.1109 to 4.8065
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.9616
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 10mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nausea.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9448
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.3067
Confidence Interval (2-Sided) 95%
0.0297 to 3.1612
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.1912
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 20mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nausea.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7996
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.6970
Confidence Interval (2-Sided) 95%
0.1061 to 4.5779
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.9604
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Common Adverse Events: Upper Respiratory Tract Infection
Hide Description Infections and Infestations. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Measure Type: Number
Unit of Measure: participants
1 2 5 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 5mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Tract Infection.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4532
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.3810
Confidence Interval (2-Sided) 95%
0.2015 to 28.1366
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.2599
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 10mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Tract Infection.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0953
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.9524
Confidence Interval (2-Sided) 95%
0.6439 to 55.0272
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.1347
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Common Adverse Events: Depression
Hide Description Psychiatric Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Measure Type: Number
Unit of Measure: participants
2 3 1 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 5mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Depression.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4402
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.8000
Confidence Interval 95%
0.2733 to 11.8558
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.9617
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 10mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Depression.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8824
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.4800
Confidence Interval (2-Sided) 95%
0.0408 to 5.6461
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.2577
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 20mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Depression.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6641
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.0909
Confidence Interval (2-Sided) 95%
0.1413 to 8.4197
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.0428
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Common Adverse Events: Somnolence
Hide Description Nervous System Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Measure Type: Number
Unit of Measure: participants
2 3 2 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 5mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Somnolence.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4402
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.8000
Confidence Interval (2-Sided) 95%
0.2733 to 11.8558
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.9617
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 10mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Somnolence.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6951
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.0000
Confidence Interval (2-Sided) 95%
0.1300 to 7.6906
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.0409
Estimation Comments [Not Specified]
27.Secondary Outcome
Title Common Adverse Events: Insomnia
Hide Description Psychiatric Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Measure Type: Number
Unit of Measure: participants
2 3 1 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 5mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Insomnia .
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4402
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.8000
Confidence Interval (2-Sided) 95%
0.2733 to 11.8558
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.9617
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 10mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Insomnia .
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8824
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.4800
Confidence Interval (2-Sided) 95%
0.0408 to 5.6461
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.2577
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 20mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Insomnia .
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8673
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.5217
Confidence Interval (2-Sided) 95%
0.0442 to 6.1537
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.2594
Estimation Comments [Not Specified]
28.Secondary Outcome
Title Common Adverse Events: Dyspepsia
Hide Description Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Measure Type: Number
Unit of Measure: participants
3 1 1 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 5mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dyspepsia .
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9294
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.3485
Confidence Interval (2-Sided) 95%
0.0337 to 3.6084
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.1919
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 10mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dyspepsia .
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9448
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.3067
Confidence Interval (2-Sided) 95%
0.0297 to 3.1612
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.1912
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 20mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dyspepsia .
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9351
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.3333
Confidence Interval (2-Sided) 95%
0.0322 to 3.4459
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.1924
Estimation Comments [Not Specified]
29.Secondary Outcome
Title Common Adverse Events: Diarrhoea
Hide Description Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Measure Type: Number
Unit of Measure: participants
2 1 2 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 5mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Diarrhoea.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8589
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.5455
Confidence Interval (2-Sided) 95%
0.0462 to 6.4433
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.2596
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 10mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Diarrhoea.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6951
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.0000
Confidence Interval (2-Sided) 95%
0.1300 to 7.6906
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.0409
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 20mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Diarrhoea.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8673
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.5217
Confidence Interval (2-Sided) 95%
0.0442 to 6.1537
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.2594
Estimation Comments [Not Specified]
30.Secondary Outcome
Title Common Adverse Events: Sinusitis
Hide Description Infections and Infestations. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Measure Type: Number
Unit of Measure: participants
3 2 1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 5mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Sinusitis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7852
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.7302
Confidence Interval (2-Sided) 95%
0.1109 to 4.8065
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.9616
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 10mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Sinusitis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9448
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.3067
Confidence Interval (2-Sided) 95%
0.0297 to 3.1612
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.1912
Estimation Comments [Not Specified]
31.Secondary Outcome
Title Common Adverse Events: Back Pain
Hide Description Musculoskeletal and Connective Tissue Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Measure Type: Number
Unit of Measure: participants
1 0 2 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 10mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Back Pain.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.0833
Confidence Interval (2-Sided) 95%
0.1771 to 24.5057
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.2576
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 20mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Back Pain.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2746
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.5714
Confidence Interval (2-Sided) 95%
0.3453 to 36.9408
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.192
Estimation Comments [Not Specified]
32.Secondary Outcome
Title Common Adverse Events: Hypotension
Hide Description Vascular Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.
Time Frame Baseline to 12 months or the time to require dopaminergic therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description:
4 Placebo to Match (PTM) tablets once daily
1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
4 Dynacirc CR 5mg tablets once daily
Overall Number of Participants Analyzed 26 23 26 24
Measure Type: Number
Unit of Measure: participants
1 1 2 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 5mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Hypotension.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7236
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.1364
Confidence Interval (2-Sided) 95%
0.0670 to 19.2640
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.4444
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 10mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Hypotension.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.0833
Confidence Interval (2-Sided) 95%
0.1771 to 24.5057
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.2576
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Isradipine CR 20mg/Day
Comments One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Hypotension.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4694
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.2727
Confidence Interval (2-Sided) 95%
0.1926 to 26.8124
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.2592
Estimation Comments [Not Specified]
Time Frame 12 months or the time to require dopaminergic therapy
Adverse Event Reporting Description All serious and most common adverse experiences/events will be listed by treatment. Most common adverse experiences/events were defined as AEs occurring more than 5 times(5%).
 
Arm/Group Title Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Hide Arm/Group Description 4 Placebo to Match (PTM) tablets once daily 1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily 2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily 4 Dynacirc CR 5mg tablets once daily
All-Cause Mortality
Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Isradipine CR 5mg/Day Isradipine CR 10mg/Day Isradipine CR 20mg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/26 (7.69%)   2/23 (8.70%)   1/26 (3.85%)   2/24 (8.33%) 
General disorders         
PYREXIA  0/26 (0.00%)  1/23 (4.35%)  0/26 (0.00%)  0/24 (0.00%) 
CHEST PAIN [1]  0/26 (0.00%)  1/23 (4.35%)  0/26 (0.00%)  0/24 (0.00%) 
Musculoskeletal and connective tissue disorders         
ARTHRALGIA  0/26 (0.00%)  0/23 (0.00%)  0/26 (0.00%)  1/24 (4.17%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
MALIGNANT MELANOMA IN SITU  0/26 (0.00%)  0/23 (0.00%)  0/26 (0.00%)  1/24 (4.17%) 
PROSTATE CANCER  1/26 (3.85%)  0/23 (0.00%)  0/26 (0.00%)  0/24 (0.00%) 
Nervous system disorders         
HYPOAESTHESIA  0/26 (0.00%)  1/23 (4.35%)  0/26 (0.00%)  0/24 (0.00%) 
Renal and urinary disorders         
RENAL FAILURE ACUTE  0/26 (0.00%)  0/23 (0.00%)  1/26 (3.85%)  0/24 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
DYSPNOEA  0/26 (0.00%)  1/23 (4.35%)  0/26 (0.00%)  0/24 (0.00%) 
Surgical and medical procedures         
VITRECTOMY  1/26 (3.85%)  0/23 (0.00%)  0/26 (0.00%)  0/24 (0.00%)