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Trial record 28 of 71 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE

Add-on to Micamlo BP Trial

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ClinicalTrials.gov Identifier: NCT01975246
Recruitment Status : Completed
First Posted : November 4, 2013
Results First Posted : November 29, 2016
Last Update Posted : November 29, 2016
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 + amlodipine
Drug: hydrochlorothiazide
Drug: Placebo
Enrollment 309
Recruitment Details  
Pre-assignment Details This study is randomised, double-blind, active-control, parallel-group comparison
Arm/Group Title Telmisartan and Amlodipine+HCTZ Telmisartan+Amlodipine
Hide Arm/Group Description Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet. Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
Period Title: Overall Study
Started 149 160
Completed 145 158
Not Completed 4 2
Reason Not Completed
Adverse Event             2             1
Lack of Efficacy             1             0
Protocol Violation             1             0
Other than stated             0             1
Arm/Group Title Telmisartan and Amlodipine+HCTZ Telmisartan+Amlodipine Total
Hide Arm/Group Description Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet. Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet Total of all reporting groups
Overall Number of Baseline Participants 149 160 309
Hide Baseline Analysis Population Description
Treated Set (TS): The treated set consisted of all patients who were randomised to the double-blind period and took at least 1 dose of the randomised treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 149 participants 160 participants 309 participants
54.4  (9.1) 55.0  (9.7) 54.7  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 149 participants 160 participants 309 participants
Female
22
  14.8%
30
  18.8%
52
  16.8%
Male
127
  85.2%
130
  81.3%
257
  83.2%
1.Primary Outcome
Title Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.
Hide Description Change from baseline in mean seated diastolic blood pressure (DBP) at trough after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints.
Time Frame baseline and week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): This analysis set was, conforming to the intent-to-treat principle, defined as all patients i) included in the treated set; and ii) taking measurements of seated DBP at reference baseline and at 1 or more time points during the double-blind period.
Arm/Group Title Telmisartan and Amlodipine+HCTZ Telmisartan+Amlodipine
Hide Arm/Group Description:
Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
Overall Number of Participants Analyzed 147 160
Mean (Standard Error)
Unit of Measure: mmHg
-8.4  (0.5) -4.5  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan and Amlodipine+HCTZ, Telmisartan+Amlodipine
Comments The last observation carried forward (LOCF) method was applied for missing data, where the value from the measurements at the closest preceding visit replaced the missing value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Model includes baseline DBP as a linear covariate, and treatment and center as fixed effects.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.9
Confidence Interval (2-Sided) 95%
-5.3 to -2.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.7
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.
Hide Description Change from baseline in mean seated systolic blood pressure (SBP) at trough after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints.
Time Frame baseline and week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Telmisartan and Amlodipine+HCTZ Telmisartan+Amlodipine
Hide Arm/Group Description:
Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
Overall Number of Participants Analyzed 147 160
Mean (Standard Error)
Unit of Measure: mmHg
-12.3  (0.8) -6.9  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan and Amlodipine+HCTZ, Telmisartan+Amlodipine
Comments The last observation carried forward (LOCF) method was applied for missing data, where the value from the measurements at the closest preceding visit replaced the missing value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Model includes baseline SBP as a linear covariate, and treatment and center as fixed effects.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.3
Confidence Interval (2-Sided) 95%
-7.6 to -3.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.1
Estimation Comments [Not Specified]
3.Secondary Outcome
Title The Proportion of Patients With DBP<90 mmHg and SBP<140 mmHg as Seated Blood Pressure at Trough After 8 Weeks of the Double-blind Period
Hide Description Patients with trough seated DBP =>90 mmHg or trough seated SBP >=140 mmHg at baseline were analysed.
Time Frame baseline and week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Telmisartan and Amlodipine+HCTZ Telmisartan+Amlodipine
Hide Arm/Group Description:
Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
Overall Number of Participants Analyzed 147 160
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
51.7
(43.3 to 60.0)
36.9
(29.4 to 44.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan and Amlodipine+HCTZ, Telmisartan+Amlodipine
Comments The Non-completers considered failure (NCF) method was applied for missing data, where missing data due to early discontinuation will be replaced as “failure” up to the planned final visit to be reached by all patients.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0051
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression model includes treatment and center as fixed effects.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.1
Confidence Interval (2-Sided) 95%
1.2 to 3.4
Estimation Comments [Not Specified]
Time Frame From first drug administration until 24 hours after the last drug administration, up to 71 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Telmisartan and Amlodipine+HCTZ Telmisartan+Amlodipine
Hide Arm/Group Description Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet. Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
All-Cause Mortality
Telmisartan and Amlodipine+HCTZ Telmisartan+Amlodipine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Telmisartan and Amlodipine+HCTZ Telmisartan+Amlodipine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/149 (0.00%)   0/160 (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+HCTZ Telmisartan+Amlodipine
Affected / at Risk (%) Affected / at Risk (%)
Total   36/149 (24.16%)   14/160 (8.75%) 
Infections and infestations     
Nasopharyngitis  1  9/149 (6.04%)  9/160 (5.63%) 
Investigations     
Blood uric acid increased  1  20/149 (13.42%)  5/160 (3.13%) 
Metabolism and nutrition disorders     
Hyperuricaemia  1  8/149 (5.37%)  1/160 (0.63%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
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.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01975246     History of Changes
Other Study ID Numbers: 1348.1
First Submitted: October 29, 2013
First Posted: November 4, 2013
Results First Submitted: October 6, 2016
Results First Posted: November 29, 2016
Last Update Posted: November 29, 2016