Conditions: Hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 858
Healthy volunteers: no

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 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.

Detailed description:

Arms:
arm 1: telmisartan and amlodipine used in combination vs amlodipine or telmisartan arm 2: telmisartan and amlodipine used in combination vs amlodipine or telmisartan arm 3: telmisartan and amlodipine used in combination vs amlodipine or telmisartan

Interventions: intervention 1: amlodipine intervention 2: telmisartan intervention 3: telmisartan and amlodipine
Intervention descriptions: intervention 1: amlodipine 5mg for the first 2w then force titration to Amlodipine 10mg for remaining 6 w intervention 2: telmisartan 80mg for the 8w, no titration required intervention 3: telmisartan 80 and amlodipine 5mg for the first 2 weeks, then force titrated to telmisartan 80mg and amlodipine 10mg for the remaining 6w

Protocol document: