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Compare Efficacy and Safety of Telmisartan/Hydrochlorothiazide With Telmisartan/Hydrochlorothiazide Plus Amlodipine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01911780
First received: July 26, 2013
Last updated: February 26, 2016
Last verified: February 2016
Results First Received: January 22, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: placebo
Drug: telmisartan + HCTZ
Drug: amlodipine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Of the 239 enrolled patients, 205 patients were entered in the run-in period and 132 were randomized. The remaining 107 patients were withdrawn from the trial before the randomization.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
An eight-week randomised, double-blind study with active-control and parallel-group comparison in Japanese patients plus 52 week extension period.

Reporting Groups
  Description
Telmisartan + HCTZ + Amlodipine telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
Telmisartan + HCTZ + Placebo telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)

Participant Flow for 2 periods

Period 1:   Double-blind Period (8 Weeks)
    Telmisartan + HCTZ + Amlodipine     Telmisartan + HCTZ + Placebo  
STARTED     68     64  
COMPLETED     65     61  
NOT COMPLETED     3     3  
Adverse Event                 1                 2  
Consent withdrawn not due to AEs                 1                 1  
Personal reason                 1                 0  

Period 2:   Extension Period (52 Weeks)
    Telmisartan + HCTZ + Amlodipine     Telmisartan + HCTZ + Placebo  
STARTED     65     61  
COMPLETED     61     58  
NOT COMPLETED     4     3  
Adverse Event                 3                 0  
Consent withdrawn not due to AEs                 0                 2  
Personal reason                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated set (TS) was defined as a collection of patients i) randomised to the double-blind period; ii) taking at least 1 dose of either T80/A5/H12.5 mg or T80/H12.5 mg during the double-blind period.

Reporting Groups
  Description
Telmisartan + HCTZ + Amlodipine telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
Telmisartan + HCTZ + Placebo telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
Total Total of all reporting groups

Baseline Measures
    Telmisartan + HCTZ + Amlodipine     Telmisartan + HCTZ + Placebo     Total  
Number of Participants  
[units: participants]
  68     64     132  
Age  
[units: Years]
Mean (Standard Deviation)
  56.1  (10.2)     54.4  (7.9)     55.2  (9.2)  
Gender  
[units: Participants]
     
Female     13     15     28  
Male     55     49     104  



  Outcome Measures
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1.  Primary:   Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.   [ Time Frame: baseline and 8 weeks ]

2.  Secondary:   Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.   [ Time Frame: baseline and 8 weeks ]

3.  Secondary:   The Percentage of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 8 Weeks of Double-blind Period.   [ Time Frame: Double-blind and 8 weeks ]

4.  Secondary:   The Number of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 52 Weeks of Extension Period.   [ Time Frame: Reference baseline (week 0) and week 60 (end of extension period) ]

5.  Secondary:   Change From Baseline in Mean DBP Pressure at Trough After 52 Weeks of the Extension Period.   [ Time Frame: Reference baseline (week 0) and week 60 (end of extension period) ]

6.  Secondary:   Change From Baseline in Mean Seated SBP at Trough After 52 Weeks of the Extension Period.   [ Time Frame: Reference baseline (week 0) and week 60 (end of extension period) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com



Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01911780     History of Changes
Other Study ID Numbers: 1348.2
Study First Received: July 26, 2013
Results First Received: January 22, 2016
Last Updated: February 26, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare