Hypertension Clinical Trial
Official title:
An Open Label Trial of the Efficacy and Safety of Chronic Administration of the Fixed Dose Combination of Telmisartan 40mg + Amlodipine 10mg or Fixed Dose Combination of Telmisartan 80mg + Amlodipine 10mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension
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).
n/a
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
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