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Trial record 57 of 71 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE
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Telmisartan 80mg Non-responder Trial

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ClinicalTrials.gov Identifier: NCT01222520
Recruitment Status : Completed
First Posted : October 18, 2010
Results First Posted : July 4, 2012
Last Update Posted : June 27, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: Telmisartan and amlodipine
Drug: Telmisartan
Enrollment 174
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Telmisartan and Amlodipine FDC Telmisartan
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Open-label run-in Period
Started 0 197
Completed 0 174
Not Completed 0 23
Reason Not Completed
Withdrawal by Subject             0             2
Blood pressure criteria not met             0             18
Number of patients fulfilled             0             3
Period Title: Double-blind Period
Started 87 87
Completed 86 85
Not Completed 1 2
Reason Not Completed
Adverse Event             0             1
Lack of Efficacy             0             1
Study medication stolen             1             0
Arm/Group Title Telmisartan and Amlodipine FDC Telmisartan Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 87 87 174
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 87 participants 87 participants 174 participants
54.5  (9.0) 54.8  (8.6) 54.6  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 87 participants 174 participants
Female
20
  23.0%
13
  14.9%
33
  19.0%
Male
67
  77.0%
74
  85.1%
141
  81.0%
1.Primary Outcome
Title Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough
Hide Description Reference baseline: Status of patients after the 8-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS)
Arm/Group Title Telmisartan and Amlodipine FDC Telmisartan
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 87 86
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
12.28  (0.73) 3.14  (0.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan and Amlodipine FDC, Telmisartan
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 Least square mean difference
Estimated Value 9.14
Confidence Interval 95%
7.09 to 11.18
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough
Hide Description Reference baseline: Status of patients after the 8-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Telmisartan and Amlodipine FDC Telmisartan
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 87 86
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
18.37  (1.10) 3.49  (1.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan and Amlodipine FDC, Telmisartan
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 Least square mean difference
Estimated Value 14.88
Confidence Interval 95%
11.82 to 17.94
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Seated DBP Control Rate at Trough
Hide Description DBP control rate: The rate of patients with controlled seated DBP at trough of less than 90 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Telmisartan and Amlodipine FDC Telmisartan
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 87 86
Measure Type: Number
Unit of Measure: Percentage of participants
No 29.9 73.3
Yes 70.1 26.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan and Amlodipine FDC, Telmisartan
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 Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Seated SBP Control Rate at Trough
Hide Description SBP control rate: The rate of patients with controlled seated SBP at trough of less than 140 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients included in FAS and with seated SBP ≥140 mmHg at reference baseline
Arm/Group Title Telmisartan and Amlodipine FDC Telmisartan
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 50 52
Measure Type: Number
Unit of Measure: Percentage of participants
No 26.0 71.2
Yes 74.0 28.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan and Amlodipine FDC, Telmisartan
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 Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Seated DBP Response Rate at Trough
Hide Description DBP response rate: The rate of patients who achieved an adequate response in seated DBP at trough (<90 mmHg and/or reduction from reference baseline ≥10 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Telmisartan and Amlodipine FDC Telmisartan
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 87 86
Measure Type: Number
Unit of Measure: Percentage of participants
No 19.5 69.8
Yes 80.5 30.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan and Amlodipine FDC, Telmisartan
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 Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Seated SBP Response Rate at Trough
Hide Description SBP response rate: The rate of patients who achieved an adequate response in seated SBP at trough (<140 mmHg and/or reduction from reference baseline ≥20 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Telmisartan and Amlodipine FDC Telmisartan
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 87 86
Measure Type: Number
Unit of Measure: Percentage of participants
No 11.5 48.8
Yes 88.5 51.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan and Amlodipine FDC, Telmisartan
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 Fisher Exact
Comments [Not Specified]
7.Secondary Outcome
Title Seated Blood Pressure (BP) Normalisation at Trough
Hide Description Seated blood pressure (BP) normalisation: The numbers of patients whose blood pressure was within normalisation criterion in terms of seated blood pressure after the 8-week double-blind period At trough: 24-hour post-dosing
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Telmisartan and Amlodipine FDC Telmisartan
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 87 86
Measure Type: Number
Unit of Measure: Participants
No 28 66
Optimal 21 2
Normal 22 7
High-normal 16 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan and Amlodipine FDC, Telmisartan
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
Time Frame From drug administration in the double blind treatment period until 24 hours after the last dosing, up to 63 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Telmisartan and Amlodipine FDC Telmisartan
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Telmisartan and Amlodipine FDC Telmisartan
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Telmisartan and Amlodipine FDC Telmisartan
Affected / at Risk (%) Affected / at Risk (%)
Total   0/87 (0.00%)   0/87 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Telmisartan and Amlodipine FDC Telmisartan
Affected / at Risk (%) Affected / at Risk (%)
Total   5/87 (5.75%)   2/87 (2.30%) 
Infections and infestations     
Nasopharyngitis † 1  5/87 (5.75%)  2/87 (2.30%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
[Not Specified]
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
ClinicalTrials.gov Identifier: NCT01222520     History of Changes
Other Study ID Numbers: 1235.36
First Submitted: October 15, 2010
First Posted: October 18, 2010
Results First Submitted: May 31, 2012
Results First Posted: July 4, 2012
Last Update Posted: June 27, 2014