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A Study of the Effectiveness and Safety of Ramipril in the Treatment of Hypertension in Children and Adolescents

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ClinicalTrials.gov Identifier: NCT00389519
Recruitment Status : Terminated (A planned interim analysis was performed after approx. 240 subjects completed the trial. The study was stopped, as permitted by protocol, after the analysis.)
First Posted : October 19, 2006
Results First Posted : May 19, 2010
Last Update Posted : June 11, 2012
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: ramipril
Drug: placebo
Enrollment 422

Recruitment Details Study was conducted from October 2006 to November 2007 at 56 international sites
Pre-assignment Details Subjects entered placebo run-in prior to randomization
Arm/Group Title Placebo Ramipril Low Dose Ramipril Mid Dose Ramipril High Dose
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified]
Period Title: Placebo Run-In
Started 422 0 0 0
Completed 244 0 0 0
Not Completed 178 0 0 0
Reason Not Completed
Did not meet blood pressure criteria             119             0             0             0
Withdrawal by Subject             19             0             0             0
Reason not specified             40             0             0             0
Period Title: Randomized
Started 83 41 40 80
Completed 81 41 40 80
Not Completed 2 0 0 0
Reason Not Completed
Did not receive study drug             2             0             0             0
Period Title: Treated
Started 81 41 40 80
Completed 79 40 40 76
Not Completed 2 1 0 4
Reason Not Completed
Adverse Event             1             0             0             2
Reason not specified             1             1             0             2
Arm/Group Title Placebo Ramipril Low Dose Ramipril Mid Dose Ramipril High Dose Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 81 41 40 80 242
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants 41 participants 40 participants 80 participants 242 participants
12.2  (3.06) 12.3  (3.03) 12.1  (2.81) 12.3  (3.06) 12.2  (2.99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 41 participants 40 participants 80 participants 242 participants
Female
32
  39.5%
16
  39.0%
11
  27.5%
29
  36.3%
88
  36.4%
Male
49
  60.5%
25
  61.0%
29
  72.5%
51
  63.7%
154
  63.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 81 participants 41 participants 40 participants 80 participants 242 participants
Black 21 11 10 20 62
Asian 8 1 4 10 23
Caucasian 27 15 13 29 84
Hispanic 25 14 13 20 72
Other 0 0 0 1 1
1.Primary Outcome
Title Change From Baseline to 4 Weeks in Trough Sitting Systolic Blood Pressure
Hide Description Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo
Time Frame Baseline to 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) analysis including only treated participants who had at least one post-baseline assessment (1 placebo patient was treated but had no post-baseline assessment); last observation carried forward (LOCF)
Arm/Group Title Placebo Ramipril Low Dose Ramipril Mid Dose Ramipril High Dose
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 80 41 40 80
Mean (Standard Deviation)
Unit of Measure: mm Hg
-8.1  (7.92) -9.7  (10.68) -11.1  (8.88) -11.3  (8.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ramipril High Dose
Comments

Planned interim efficacy analysis: 80 placebo and 80 high-dose ramipril subjects provided 93% power, alpha=0.032, to detect 5 mmHg difference in primary outcome. SD of 8.5 mmHg assumed. Alpha of 0.032 required for the planned interim efficacy analysis.

If study continued: 450 total subjects would provide 90% power, alpha=0.027, to detect 3 mmHg difference between placebo and combined ramipril dose groups. Alpha of 0.027 required for the final analysis.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.044
Comments two-sided test
Method ANCOVA
Comments test from contrast statement from full model
2.Secondary Outcome
Title Change From Baseline to 4 Weeks in Trough Sitting Diastolic Blood Pressure
Hide Description Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo
Time Frame Baseline to 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) analysis including only treated participants who had at least one post-baseline assessment (1 placebo patient was treated but had no post-baseline assessment); last observation carried forward (LOCF)
Arm/Group Title Placebo Ramipril Low Dose Ramipril Mid Dose Ramipril High Dose
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 80 41 40 80
Mean (Standard Deviation)
Unit of Measure: mm Hg
-5.0  (10.04) -5.8  (10.17) -6.1  (8.03) -8.4  (9.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ramipril High Dose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments two-sided, unadjusted
Method ANCOVA
Comments test from contrast statement from full model
3.Secondary Outcome
Title Change From Baseline to 4 Weeks in Serum Creatinine
Hide Description Value at end of treatment (up to 4 weeks) minus value at baseline
Time Frame Baseline up to 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed is less than number treated in the participant flow section because analysis includes only treated participants who had both a baseline and a post-baseline assessment; LOCF
Arm/Group Title Placebo Ramipril Low Dose Ramipril Mid Dose Ramipril High Dose
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 78 39 38 77
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.04  (0.305) 0.06  (0.275) 0.03  (0.133) 0.06  (0.211)
4.Secondary Outcome
Title Change From Baseline to 4 Weeks in Serum Potassium
Hide Description Value at end of treatment (up to 4 weeks) minus value at baseline
Time Frame Baseline up to 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed is less than number treated in the participant flow section because analysis includes only treated participants who had both a baseline and a post-baseline assessment; LOCF
Arm/Group Title Placebo Ramipril Low Dose Ramipril Mid Dose Ramipril High Dose
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 79 39 40 77
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.01  (0.742) -0.20  (0.475) -0.08  (0.418) 0.07  (0.559)
5.Secondary Outcome
Title Change From Baseline to 4 Weeks in Schwartz Formula Glomerular Filtration Rate (GFR)
Hide Description Value at end of treatment (up to 4 weeks) minus value at baseline; GFR is a measure of kidney function.
Time Frame Baseline up to 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed is less than number treated in the participant flow section because analysis includes only treated participants who had both a baseline and a post-baseline assessment; LOCF
Arm/Group Title Placebo Ramipril Low Dose Ramipril Mid Dose Ramipril High Dose
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 78 39 38 77
Mean (Standard Deviation)
Unit of Measure: mL/min per 1.73 m2
-4.2  (27.85) -6.0  (24.74) -5.9  (26.29) -6.9  (30.58)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Ramipril Low Dose Ramipril Mid Dose Ramipril High Dose
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Placebo Ramipril Low Dose Ramipril Mid Dose Ramipril High Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Ramipril Low Dose Ramipril Mid Dose Ramipril High Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/81 (0.00%)   1/41 (2.44%)   1/40 (2.50%)   0/80 (0.00%) 
Infections and infestations         
pyelonephritis  1  0/81 (0.00%)  1/41 (2.44%)  0/40 (0.00%)  0/80 (0.00%) 
Renal and urinary disorders         
nephrotic syndrome  1  0/81 (0.00%)  0/41 (0.00%)  1/40 (2.50%)  0/80 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Ramipril Low Dose Ramipril Mid Dose Ramipril High Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/81 (13.58%)   8/41 (19.51%)   6/40 (15.00%)   12/80 (15.00%) 
Gastrointestinal disorders         
abdominal pain upper  1  2/81 (2.47%)  0/41 (0.00%)  3/40 (7.50%)  1/80 (1.25%) 
General disorders         
chest pain  1  0/81 (0.00%)  0/41 (0.00%)  3/40 (7.50%)  0/80 (0.00%) 
Infections and infestations         
upper respiratory tract infection  1  2/81 (2.47%)  4/41 (9.76%)  1/40 (2.50%)  1/80 (1.25%) 
Nervous system disorders         
dizziness  1  2/81 (2.47%)  0/41 (0.00%)  2/40 (5.00%)  2/80 (2.50%) 
headache  1  6/81 (7.41%)  4/41 (9.76%)  3/40 (7.50%)  8/80 (10.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Investigator agreed not to individually publish results of the study. Investigators may participate in a joint multicenter publication of the study results. Written notice must be provided to King. King has the right to review the publication and can require deletion of Confidential Information and delay of publication to allow for filing of patent applications.
Results Point of Contact
Name/Title: Professional Information Services
Organization: King Pharmaceuticals, Inc.
Phone: 1-800-776-3637
ClinicalTrials.gov Identifier: NCT00389519     History of Changes
Other Study ID Numbers: K726-06-4003
First Submitted: October 17, 2006
First Posted: October 19, 2006
Results First Submitted: January 21, 2010
Results First Posted: May 19, 2010
Last Update Posted: June 11, 2012