Conditions: Hypertension
Enrollment: 838
Healthy volunteers: no

Brief summary:
The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10) during open-label treatment for at least six months.

An additional objective is to assess the efficacy and safety of concomitant administration of either T40/A10 or T80/A10 with any other therapies commonly used in the treatment of hypertension.

The primary endpoint is the proportion of patients achieving DBP control (defined as mean seated DBP \< 90 mmHg at trough i.e. approximately 24 hours after last dose of study treatment) at six months of treatment or at last trough observation during the treatment period (i.e. last trough observation carried forward).

Detailed description:

Arms:

Interventions: intervention 1: fixed-dose combination of telmisartan 40mg+amlodipine 10mg intervention 2: fixed-dose combination of telmisartan 80mg+amlodipine10mg
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: