drugset / Trial / NCT00860262

Telmisartan and Amlodipine Fixed Dose Combination [FDC] Trial for the Treatment of Severe Hypertension

NCT00860262

Phase 3 Completed 858 enrolled Boehringer Ingelheim
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2009-03
Primary completion
2009-12
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amlodipine Other / unclassified 10 mg
Comparator Telmisartan Other / unclassified 80 mg

Indications