Status:
COMPLETED
Telmisartan and Amlodipine Fixed Dose Combination [FDC] Trial for the Treatment of Severe Hypertension
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of this trial is to demonstrate that following eight weeks of treatment the FDC of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first line therapy in reducing...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation
- Age 18 years or older
- Patients with severe hypertension as defined SBP greater than 180 mmHg and DBP greater than 95 mmHg at randomisation
- Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigators discretion)
- Exclusion criteria Mean in-clinic seated cuff SBP \>/= 200 mmHg and/or Diastolic Blood Pressure \[DBP\] \>/= 95 mmHg
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
858 Patients enrolled
Trial Details
Trial ID
NCT00860262
Start Date
March 1 2009
Last Update
May 20 2014
Active Locations (137)
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1
1235.20.525 Boehringer Ingelheim Investigational Site
Buena Park, California, United States
2
1235.20.503 Boehringer Ingelheim Investigational Site
Long Beach, California, United States
3
1235.20.507 Boehringer Ingelheim Investigational Site
Long Beach, California, United States
4
1235.20.529 Boehringer Ingelheim Investigational Site
Roseville, California, United States