Telmisartan and Amlodipine Versus Monocomponent Tablets

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01278797
First received: January 17, 2011
Last updated: February 28, 2014
Last verified: February 2014
Results First Received: February 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind;   Primary Purpose: Basic Science
Condition: Hypertension
Interventions: Drug: Telmisartan/Amlodipine Combination Tablet
Drug: Amlodipine Monocomponent

  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
No text entered.

Reporting Groups
  Description
Telm/Amlo 80 mg/10 mg First, Then Telm 80 mg + Amlo 10 mg Combination tablet followed by individual components
Telm 80 mg + Amlo 10 mg First, Then Telm/Amlo 80 mg/10 mg Individual components followed by Combination tablet

Participant Flow for 3 periods

Period 1:   Period 1
    Telm/Amlo 80 mg/10 mg First, Then Telm 80 mg + Amlo 10 mg     Telm 80 mg + Amlo 10 mg First, Then Telm/Amlo 80 mg/10 mg  
STARTED     14     14  
COMPLETED     13     13  
NOT COMPLETED     1     1  
Adverse Event                 0                 1  
Protocol Violation                 1                 0  

Period 2:   Washout Period of 21 Days
    Telm/Amlo 80 mg/10 mg First, Then Telm 80 mg + Amlo 10 mg     Telm 80 mg + Amlo 10 mg First, Then Telm/Amlo 80 mg/10 mg  
STARTED     13     13  
COMPLETED     13     13  
NOT COMPLETED     0     0  

Period 3:   Period 2
    Telm/Amlo 80 mg/10 mg First, Then Telm 80 mg + Amlo 10 mg     Telm 80 mg + Amlo 10 mg First, Then Telm/Amlo 80 mg/10 mg  
STARTED     13     13  
COMPLETED     13     13  
NOT COMPLETED     0     0  



  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.
No text entered.

Reporting Groups
  Description
Entire Study Population Includes all subjects randomized to either treatment sequence

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  28  
Age  
[units: years]
Mean ± Standard Deviation
  39  ± 9  
Gender  
[units: participants]
 
Female     1  
Male     27  
Race/Ethnicity, Customized  
[units: participants]
 
Hispanic/Latino     7  
Asian     3  
Black/African American     6  
White     12  
Height  
[units: centimeter]
Mean ± Standard Deviation
  173.1  ± 7.1  
Weight  
[units: kilogram]
Mean ± Standard Deviation
  80.3  ± 9.9  
Body Mass Index  
[units: kilogram / square meter]
Mean ± Standard Deviation
  26.7  ± 2.5  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Area Under the Concentration-time Curve of Plasma Amlodipine From 0 to 72 Hours (AUC72)   [ Time Frame: Day 1, Day 22 ]

2.  Primary:   Maximum Observed Plasma Concentration (Cmax) of Amlodipine   [ Time Frame: Day 1, Day 22 ]

3.  Secondary:   Time of Maximum Concentration of Amlodipine (TMAX)   [ Time Frame: Day 1, Day 22 ]


  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 Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01278797     History of Changes
Other Study ID Numbers: 1235.41
Study First Received: January 17, 2011
Results First Received: February 13, 2012
Last Updated: February 28, 2014
Health Authority: Canada: Health Canada