drugset / Trial / NCT00624052

26-week Open Study of telmisartan40mg+amlodipine10mg or telmisartan80mg+amlodipine10 mg in Hypertension

NCT00624052

Phase 3 Completed 838 enrolled Boehringer Ingelheim
Treatment

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).

Timeline

Start
2008-03
Primary completion
2009-06
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Amlodipine Other / unclassified 10 mg
Subject Telmisartan Other / unclassified 40 mg
Subject Telmisartan Other / unclassified 80 mg

Indications