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Filtered Trial for Telmisartan 40mg Non-responder

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: NCT00550953
Recruitment Status : Completed
First Posted : October 30, 2007
Results First Posted : February 2, 2010
Last Update Posted : January 30, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Interventional
Study Design Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: telmisartan+amlodipine
Drug: telmisartan
Enrollment 314
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination Telmisartan 40 mg Monotherapy
Hide Arm/Group Description T40/A5 tablet, oral, once daily in the morning A5 capsule, oral, once daily in the morning
Period Title: Overall Study
Started 156 158
Completed 150 152
Not Completed 6 6
Reason Not Completed
Adverse Event             4             3
Not able to visit the site             2             3
Arm/Group Title Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination Telmisartan 40 mg Monotherapy Total
Hide Arm/Group Description T40/A5 tablet, oral, once daily in the morning A5 capsule, oral, once daily in the morning Total of all reporting groups
Overall Number of Baseline Participants 156 158 314
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 156 participants 158 participants 314 participants
55.4  (9.1) 55.5  (10.2) 55.5  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 156 participants 158 participants 314 participants
Female
42
  26.9%
35
  22.2%
77
  24.5%
Male
114
  73.1%
123
  77.8%
237
  75.5%
1.Primary Outcome
Title Decrease in Seated Diastolic Blood Pressure From Baseline to 8 Weeks
Hide Description The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.
Time Frame Baseline and 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.
Arm/Group Title Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination Telmisartan 40 mg Monotherapy
Hide Arm/Group Description:
T40/A5 tablet, oral, once daily in the morning
A5 capsule, oral, once daily in the morning
Overall Number of Participants Analyzed 153 158
Mean (Standard Error)
Unit of Measure: mmHg
13.49  (0.63) 5.47  (0.62)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination, Telmisartan 40 mg Monotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.02
Confidence Interval (2-Sided) 95%
6.41 to 9.63
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.82
Estimation Comments Difference calculated as telmisartan 40 mg plus amlodipine 5 mg fixed-dose combination minus telmisartan 40 mg monotherapy
2.Secondary Outcome
Title Decrease in Seated Systolic Blood Pressure From Baseline to 8 Weeks
Hide Description The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.
Arm/Group Title Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination Telmisartan 40 mg Monotherapy
Hide Arm/Group Description:
T40/A5 tablet, oral, once daily in the morning
A5 capsule, oral, once daily in the morning
Overall Number of Participants Analyzed 153 158
Mean (Standard Error)
Unit of Measure: mmHg
17.86  (0.86) 6.51  (0.84)
3.Secondary Outcome
Title Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline)
Hide Description Seated trough diastolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.
Arm/Group Title Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination Telmisartan 40 mg Monotherapy
Hide Arm/Group Description:
T40/A5 tablet, oral, once daily in the morning
A5 capsule, oral, once daily in the morning
Overall Number of Participants Analyzed 153 158
Measure Type: Number
Unit of Measure: percentage of participants
78.4 46.8
4.Secondary Outcome
Title Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline)
Hide Description Seated trough systolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.
Arm/Group Title Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination Telmisartan 40 mg Monotherapy
Hide Arm/Group Description:
T40/A5 tablet, oral, once daily in the morning
A5 capsule, oral, once daily in the morning
Overall Number of Participants Analyzed 101 97
Measure Type: Number
Unit of Measure: percentage of participants
81.2 37.1
5.Secondary Outcome
Title Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline)
Hide Description Adequate response defined that seated trough diastolic blood pressure was <90 mmHg or decreased from reference baseline by >=10 mmHg at 8 weeks
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.
Arm/Group Title Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination Telmisartan 40 mg Monotherapy
Hide Arm/Group Description:
T40/A5 tablet, oral, once daily in the morning
A5 capsule, oral, once daily in the morning
Overall Number of Participants Analyzed 153 158
Measure Type: Number
Unit of Measure: percentage of participants
85 50
6.Secondary Outcome
Title Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks (0 Percent at Baseline)
Hide Description Adequate response defined that seated trough systolic blood pressure was <140 mmHg or decreased from reference baseline by >=20 mmHg at 8 weeks (0 percent at baseline)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.
Arm/Group Title Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination Telmisartan 40 mg Monotherapy
Hide Arm/Group Description:
T40/A5 tablet, oral, once daily in the morning
A5 capsule, oral, once daily in the morning
Overall Number of Participants Analyzed 153 158
Measure Type: Number
Unit of Measure: percentage of participants
89.5 58.2
7.Secondary Outcome
Title Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline)
Hide Description

Optimal, normal, high normal blood pressure were defined as follows:

  • Optimal: Systolic blood pressure (SBP) < 120 mmHg and diastolic blood pressure (DBP) < 80 mmHg
  • Normal: SBP >= 120 mmHg or DBP >= 80 mmHg and SBP < 130 mmHg and DBP < 85 mmHg
  • High normal: SBP >= 130 mmHg or DBP >= 85 mmHg and SBP < 140 mmHg and DBP < 90 mmHg
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.
Arm/Group Title Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination Telmisartan 40 mg Monotherapy
Hide Arm/Group Description:
T40/A5 tablet, oral, once daily in the morning
A5 capsule, oral, once daily in the morning
Overall Number of Participants Analyzed 153 158
Measure Type: Number
Unit of Measure: percentage of participants
Optimal 17.0 3.2
Normal 30.7 17.1
High Normal 26.1 17.1
8.Secondary Outcome
Title Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG
Hide Description Clinical relevant abnormalities for changes in blood pressure and pulse rate due to position change, seated pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
Time Frame First administration of randomised treatment to 24 hours post last dose of randomised treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Patients randomised to the double-blind treatment period who took at least one dose either of T40+A5 or T40 during the double-blind treatment period.
Arm/Group Title Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination Telmisartan 40 mg Monotherapy
Hide Arm/Group Description:
T40/A5 tablet, oral, once daily in the morning
A5 capsule, oral, once daily in the morning
Overall Number of Participants Analyzed 156 158
Measure Type: Number
Unit of Measure: participants
Arrhythmia 1 0
Blood potassium increased 1 0
Blood pressure increased 0 2
Eosinophil count increased 1 0
Orthostatic hypotension 1 0
Time Frame From drug administration until 24 hours after last drug administration
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination Telmisartan 40 mg Monotherapy
Hide Arm/Group Description T40/A5 tablet, oral, once daily in the morning A5 capsule, oral, once daily in the morning
All-Cause Mortality
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination Telmisartan 40 mg Monotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination Telmisartan 40 mg Monotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   1/156 (0.64%)   0/158 (0.00%) 
Injury, poisoning and procedural complications     
Forearm fracture  1  1/156 (0.64%)  0/158 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination Telmisartan 40 mg Monotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   19/156 (12.18%)   16/158 (10.13%) 
Infections and infestations     
Nasopharyngitis  1  19/156 (12.18%)  16/158 (10.13%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
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.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00550953    
Other Study ID Numbers: 1235.14
First Submitted: October 26, 2007
First Posted: October 30, 2007
Results First Submitted: November 12, 2009
Results First Posted: February 2, 2010
Last Update Posted: January 30, 2014