Open Label Study Telmisartan and Amlodipine in Hypertension

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00614380
First received: January 28, 2008
Last updated: December 16, 2013
Last verified: December 2013
Results First Received: December 14, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: telmisartan/amlodipine 40/5 mg fixed combination
Drug: telmisartan/amlodipine 80/5 mg fixed combination

  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 40mg and Amlodipine 5mg No text entered.
Telmisartan 80mg and Amlodipine 5mg No text entered.
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive No text entered.
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive No text entered.

Participant Flow:   Overall Study
    Telmisartan 40mg and Amlodipine 5mg     Telmisartan 80mg and Amlodipine 5mg     Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive     Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive  
STARTED     564     206     25     181  
COMPLETED     529     198     24     179  
NOT COMPLETED     35     8     1     2  
Adverse Event                 14                 4                 0                 0  
Lost to Follow-up                 6                 1                 0                 0  
Non compliant with the protocol                 12                 2                 1                 2  
Consent withdrawn                 3                 1                 0                 0  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.
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Reporting Groups
  Description
Telmisartan 40mg and Amlodipine 5mg No text entered.
Telmisartan 80mg and Amlodipine 5mg No text entered.
Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive No text entered.
Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive No text entered.
Total Total of all reporting groups

Baseline Measures
    Telmisartan 40mg and Amlodipine 5mg     Telmisartan 80mg and Amlodipine 5mg     Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive     Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive     Total  
Number of Participants  
[units: participants]
  564     206     25     181     976  
Age  
[units: Years]
Mean ± Standard Deviation
  54.8  ± 10.9     52.9  ± 10.6     54.4  ± 10.8     52.4  ± 9.6     53.9  ± 10.6  
Gender  
[units: participants]
         
Female     240     72     8     45     365  
Male     324     134     17     136     611  



  Outcome Measures
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1.  Primary:   Trough Seated Diastolic Blood Pressure (DBP) Control   [ Time Frame: End of study (34 weeks or last value on treatment) ]

2.  Secondary:   Trough Seated Systolic Blood Pressure (SBP) Control   [ Time Frame: End of study (34 weeks or last value on treatment) ]

3.  Secondary:   Change From Baseline in Trough Seated Diastolic Blood Pressure   [ Time Frame: End of study (34 weeks or last value on treatment) ]

4.  Secondary:   Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7   [ Time Frame: End of study (34 weeks or last value on treatment) ]

5.  Secondary:   Change From Baseline in Trough Seated Systolic Blood Pressure   [ Time Frame: End of study (34 weeks or last value on treatment) ]

6.  Secondary:   Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7   [ Time Frame: End of study (34 weeks or last value on treatment) ]

7.  Secondary:   Trough Seated DBP Response   [ Time Frame: End of study (34 weeks or last value on treatment) ]

8.  Secondary:   Trough Seated SBP Response   [ Time Frame: End of study (34 weeks or last value on treatment) ]

9.  Secondary:   Trough Blood Pressure (BP) Normality Classes   [ Time Frame: End of study (34 weeks or last value on treatment) ]

10.  Secondary:   Time to First Additional Antihypertensive   [ Time Frame: At any point during open-label treatment ]

11.  Secondary:   Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control   [ Time Frame: At any point during open-label treatment ]

12.  Secondary:   Additional Reduction in DBP by Use of Additional Antihypertensive Therapy   [ Time Frame: At any point during open-label treatment ]

13.  Secondary:   Additional Reduction in SBP by Use of Additional Antihypertensive Therapy   [ Time Frame: At any point during open-label treatment ]

14.  Secondary:   Trough DBP Control Pre- and Post- Uptitration   [ Time Frame: At any point during open-label treatment ]


  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: NCT00614380     History of Changes
Other Study ID Numbers: 1235.7, EUDRACT2007-002410-19
Study First Received: January 28, 2008
Results First Received: December 14, 2009
Last Updated: December 16, 2013
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada (TPD)
Denmark: Lægemiddelstyrelsen, Kliniske forsøg, Inspektionen Axel Heides Gade 1, DK-2300 Copenhagen S
Finland: Finnish Medicines Agency
France: AGENCE FRANCAISE DE SECURITE SANITAIRE DES PRODUITS DE SANTE
Korea, Republic of: Korea Food and Drug Administration (KFDA)
Netherlands: Central Committee on Research involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency (Statens Legemiddelverk)
Philippines: Department of Health, Republic of the Philippines
South Africa: Medicines Control Council
Sweden: Regional Ethics Committee of Stockholm, PO Box 289, SE-17177 Stockholm, Sweden. Medical Products Agency
Taiwan: Department of Health, Executive Yuan, Taiwan
United States: Food and Drug Administration