Telmisartan/Amlodipine (80/10) vs. Telmisartan/Amlodipine (40/10) vs. amlodipine10 in Resistant Hypertension

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00553267
First received: October 8, 2007
Last updated: December 16, 2013
Last verified: December 2013
Results First Received: November 18, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: fixed dose combination of telmisartan+amlodipine
Drug: amlodipine

  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
Amlodipine 10mg No text entered.
Telmisartan 40mg and Amlodipine 10mg No text entered.
Telmisartan 80mg and Amlodipine 10mg No text entered.

Participant Flow:   Overall Study
    Amlodipine 10mg     Telmisartan 40mg and Amlodipine 10mg     Telmisartan 80mg and Amlodipine 10mg  
STARTED     315     315     317  
COMPLETED     301     297     307  
NOT COMPLETED     14     18     10  
Adverse Event                 8                 10                 5  
Non compliant with protocol                 3                 3                 2  
Lost to Follow-up                 0                 0                 1  
Consent withdrawn                 2                 3                 1  
Specified category                 1                 2                 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.
No text entered.

Reporting Groups
  Description
Amlodipine 10mg No text entered.
Telmisartan 40mg and Amlodipine 10mg No text entered.
Telmisartan 80mg and Amlodipine 10mg No text entered.
Total Total of all reporting groups

Baseline Measures
    Amlodipine 10mg     Telmisartan 40mg and Amlodipine 10mg     Telmisartan 80mg and Amlodipine 10mg     Total  
Number of Participants  
[units: participants]
  315     315     317     947  
Age  
[units: Years]
Mean ± Standard Deviation
  56.4  ± 10.4     57.6  ± 9.4     55.5  ± 9.8     56.5  ± 9.9  
Gender  
[units: Number¬†of¬†participants]
       
Female     128     145     146     419  
Male     187     170     171     528  



  Outcome Measures
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1.  Primary:   Change From Baseline in Trough Seated Diastolic Blood Pressure   [ Time Frame: Baseline and end of study (8 weeks or last value on treatment) ]

2.  Secondary:   Change From Baseline in Trough Seated Systolic Blood Pressure   [ Time Frame: Baseline and end of study (8 weeks or last value on treatment) ]

3.  Secondary:   Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg)   [ Time Frame: End of study (8 weeks or last value on treatment) ]

4.  Secondary:   Trough Seated Diastolic Blood Pressure <80 mmHg   [ Time Frame: End of study (8 weeks or last value on treatment) ]

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

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

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

8.  Secondary:   Trough Seated BP Normality Classes   [ Time Frame: End of study (8 weeks or last value on treatment) ]

9.  Secondary:   Oedema Incidence Rate   [ Time Frame: During randomised treatment period ]

10.  Secondary:   Peripheral Oedema Incidence Rate   [ Time Frame: During randomised treatment period ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.  


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: NCT00553267     History of Changes
Other Study ID Numbers: 1235.6, EUDRACT 2007-002421-68
Study First Received: October 8, 2007
Results First Received: November 18, 2009
Last Updated: December 16, 2013
Health Authority: Australia: Responsilble Ethics Committee
Austria: Federal Office for Safety in Health Care
Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia
Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10
Great Britain: MHRA
Ireland: Irish Medicines Board
Italy: Comitato Etico della provinciale di Ferrara
New Zealand: Multicentre Ethics Committee/Medsafe
Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow
Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26
Spain: Agencia Española del Medicamento y Productos Sanitarios
Switzerland: Swissmedic, Hallerstrasse 7, 3000 Bern
Turkey: Ministry of Health Central Ethics Committee
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)