drugset / Trial / NCT01103960

An Eight-week Randomized,Double-blind Study to Evaluate the Efficacy and Safety of Fixed-dose Combinations of T80+A5 Versus A5 Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With A5 Monotherapy

NCT01103960

Phase 3 Completed 324 enrolled Boehringer Ingelheim
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objectives of this trial is to demonstrate that the fixed-dose combination of telmisartan 80mg plus amlodipine 5mg (T80/A5) is superior to amlodipine 5mg (A5) in reducing seated trough diastolic blood pressure (DBP) at 8 weeks.

Timeline

Start
2010-07
Primary completion
2011-08
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amlodipine Other / unclassified 5 mg
Subject Telmisartan Other / unclassified 80 mg

Indications