Telmisartan and Amlodipine Fixed Dose Combination [FDC] Trial for the Treatment of Severe Hypertension
Completed · Phase 3
Conditions studied: Hypertension
In brief
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 mean seated trough cuff Systolic Blood Pressure \[SBP\] compared to the monotherapies of telmisartan 80 mg (T80) and amlodipine 10 mg (A10) in patients with severe hypertension. A key secondary objective is to identify the duration of treatment required to demonstrate the superiority of the FDC over both of the monotherapies.
Key facts
- Study ID
- NCT00860262
- Run by
- Boehringer Ingelheim
- People needed
- 858
- Starts
- 2009-03-01
- Last updated by the study team
- 2014-05-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- 1235.20.503 Boehringer Ingelheim Investigational Site — Long Beach, California, United States
- 1235.20.507 Boehringer Ingelheim Investigational Site — Long Beach, California, United States
- 1235.20.529 Boehringer Ingelheim Investigational Site — Roseville, California, United States
- 1235.20.518 Boehringer Ingelheim Investigational Site — Tustin, California, United States
- 1235.20.521 Boehringer Ingelheim Investigational Site — Westlake Village, California, United States
- 1235.20.508 Boehringer Ingelheim Investigational Site — DeLand, Florida, United States
- 1235.20.506 Boehringer Ingelheim Investigational Site — Hialeah, Florida, United States
- 1235.20.519 Boehringer Ingelheim Investigational Site — Pembroke Pines, Florida, United States
- 1235.20.523 Boehringer Ingelheim Investigational Site — Port Orange, Florida, United States
- 1235.20.528 Boehringer Ingelheim Investigational Site — Blue Ridge, Georgia, United States
- 1235.20.516 Boehringer Ingelheim Investigational Site — North Dartmouth, Massachusetts, United States
- 1235.20.527 Boehringer Ingelheim Investigational Site — Bay City, Michigan, United States
- 1235.20.510 Boehringer Ingelheim Investigational Site — Las Vegas, Nevada, United States
- 1235.20.512 Boehringer Ingelheim Investigational Site — Albuquerque, New Mexico, United States
- 1235.20.509 Boehringer Ingelheim Investigational Site — The Bronx, New York, United States
- 1235.20.511 Boehringer Ingelheim Investigational Site — Kettering, Ohio, United States
- 1235.20.515 Boehringer Ingelheim Investigational Site — Tulsa, Oklahoma, United States
- 1235.20.534 Boehringer Ingelheim Investigational Site — Medford, Oregon, United States
- 1235.20.526 Boehringer Ingelheim Investigational Site — Erie, Pennsylvania, United States
- 1235.20.513 Boehringer Ingelheim Investigational Site — Tipton, Pennsylvania, United States
- 1235.20.517 Boehringer Ingelheim Investigational Site — Providence, Rhode Island, United States
- 1235.20.522 Boehringer Ingelheim Investigational Site — Carrollton, Texas, United States
- 1235.20.520 Boehringer Ingelheim Investigational Site — Houston, Texas, United States
- 1235.20.530 Boehringer Ingelheim Investigational Site — Killeen, Texas, United States
- 1235.20.525 Boehringer Ingelheim Investigational Site — Buena Park, California, United States
Full record on ClinicalTrials.gov
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