An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00618774
First received: February 8, 2008
Last updated: June 17, 2014
Last verified: April 2014
Results First Received: December 28, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: telmisartan40/amlodipine5
Drug: telmisartan80/amlodipine5

  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 40 mg Plus Amlodipine 5 mg Fixed-dose Combination No text entered.
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination No text entered.

Participant Flow:   Overall Study
    Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination     Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination  
STARTED     211     48  
COMPLETED     205     45  
NOT COMPLETED     6     3  
Adverse Event                 5                 3  
Withdrawal by Subject                 1                 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.
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Reporting Groups
  Description
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination No text entered.
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination No text entered.
Total Total of all reporting groups

Baseline Measures
    Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination     Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination     Total  
Number of Participants  
[units: participants]
  211     48     259  
Age  
[units: Years]
Mean ± Standard Deviation
  56.8  ± 9     51.1  ± 8     55.8  ± 9  
Gender  
[units: participants]
     
Female     50     4     54  
Male     161     44     205  



  Outcome Measures
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1.  Primary:   Percentage of Participants Who Experienced Adverse Events   [ Time Frame: 52 weeks ]

2.  Primary:   Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG   [ Time Frame: First administration of study treatment to 24 hours post last dosing of study treatment. ]

3.  Secondary:   Change From Baseline in Seated Diastolic Blood Pressure at Week 8   [ Time Frame: Baseline and week 8 ]

4.  Secondary:   Change From Baseline in Seated Systolic Blood Pressure at Week 8   [ Time Frame: Baseline and week 8 ]

5.  Secondary:   Seated DBP Control Rate at Trough After 8 Weeks   [ Time Frame: week 8 ]

6.  Secondary:   Seated SBP Control Rate at Trough After 8 Weeks   [ Time Frame: Week 8 ]

7.  Secondary:   Change From Baseline in Seated Diastolic Blood Pressure   [ Time Frame: Baseline and week 20 / week 48 ]

8.  Secondary:   Change From Baseline in Seated Systolic Blood Pressure   [ Time Frame: Baseline and week 20 / week 48 ]

9.  Secondary:   Seated DBP Control Rate at Trough After 6 and 12 Months   [ Time Frame: 6 months and 12 months ]

10.  Secondary:   Seated SBP Control Rate at Trough After 6 and 12 Months   [ Time Frame: 6 months and 12 months ]

11.  Secondary:   Seated DBP Response Rate at Trough   [ Time Frame: 6 months and 12 months ]

12.  Secondary:   Seated SBP Response Rate at Trough   [ Time Frame: 6 months and 12 months ]

13.  Secondary:   Seated Blood Pressure Normalisation at Trough   [ Time Frame: 6 months and 12 months ]


  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: NCT00618774     History of Changes
Other Study ID Numbers: 1235.16
Study First Received: February 8, 2008
Results First Received: December 28, 2009
Last Updated: June 17, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare