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Add-on to Micamlo BP Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01975246
First received: October 29, 2013
Last updated: October 6, 2016
Last verified: October 2016
Results First Received: October 6, 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: Telmisartan + amlodipine
Drug: hydrochlorothiazide
Drug: Placebo

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This study is randomised, double-blind, active-control, parallel-group comparison

Reporting Groups
  Description
Telmisartan and Amlodipine+HCTZ 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.
Telmisartan+Amlodipine 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

Participant Flow:   Overall Study
    Telmisartan and Amlodipine+HCTZ   Telmisartan+Amlodipine
STARTED   149   160 
COMPLETED   145   158 
NOT COMPLETED   4   2 
Adverse Event                2                1 
Lack of Efficacy                1                0 
Protocol Violation                1                0 
Other than stated                0                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): 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.

Reporting Groups
  Description
Telmisartan and Amlodipine+HCTZ 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.
Telmisartan+Amlodipine 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 Total of all reporting groups

Baseline Measures
   Telmisartan and Amlodipine+HCTZ   Telmisartan+Amlodipine   Total 
Overall Participants Analyzed 
[Units: Participants]
 149   160   309 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.4  (9.1)   55.0  (9.7)   54.7  (9.4) 
Gender 
[Units: Participants]
     
Female   22   30   52 
Male   127   130   257 


  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 week 8 ]

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

3.  Secondary:   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   [ Time Frame: baseline and week 8 ]


  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: NCT01975246     History of Changes
Other Study ID Numbers: 1348.1
Study First Received: October 29, 2013
Results First Received: October 6, 2016
Last Updated: October 6, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare