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Telmisartan 80mg Non-responder Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01222520
First received: October 15, 2010
Last updated: July 23, 2012
Last verified: July 2012
History of Changes
Results First Received: May 31, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Telmisartan and amlodipine
Drug: Telmisartan

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Telmisartan and Amlodipine FDC No text entered.
Telmisartan No text entered.

Participant Flow for 2 periods

 Period 1:   Open-label run-in Period
    Telmisartan and Amlodipine FDC     Telmisartan  
STARTED     0     197  
COMPLETED     0     174  
NOT COMPLETED     0     23  
Withdrawal by Subject                 0                 2  
Blood pressure criteria not met                 0                 18  
Number of patients fulfilled                 0                 3  

Period 2:   Double-blind Period
    Telmisartan and Amlodipine FDC     Telmisartan  
STARTED     87     87  
COMPLETED     86     85  
NOT COMPLETED     1     2  
Adverse Event                 0                 1  
Lack of Efficacy                 0                 1  
Study medication stolen                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Telmisartan and Amlodipine FDC No text entered.
Telmisartan No text entered.
Total Total of all reporting groups

Baseline Measures
    Telmisartan and Amlodipine FDC     Telmisartan     Total  
Number of Participants  
[units: participants]
 		  87     87     174  
Age  
[units: year]
Mean ± Standard Deviation 		  54.5  ± 9.0     54.8  ± 8.6     54.6  ± 8.8  
Gender  
[units: Participants]
 		     
Female     20     13     33  
Male     67     74     141  



  Outcome Measures
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1.  Primary:   Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough   [ Time Frame: Baseline, 8 weeks ]
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2.  Secondary:   Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough   [ Time Frame: Baseline, 8 weeks ]
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3.  Secondary:   Seated DBP Control Rate at Trough   [ Time Frame: 8 weeks ]
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4.  Secondary:   Seated SBP Control Rate at Trough   [ Time Frame: 8 weeks ]
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5.  Secondary:   Seated DBP Response Rate at Trough   [ Time Frame: 8 weeks ]
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6.  Secondary:   Seated SBP Response Rate at Trough   [ Time Frame: 8 weeks ]
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7.  Secondary:   Seated Blood Pressure (BP) Normalisation at Trough   [ Time Frame: 8 weeks ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


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


No publications provided


Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01222520     History of Changes
Other Study ID Numbers: 1235.36
Study First Received: October 15, 2010
Results First Received: May 31, 2012
Last Updated: July 23, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare