drugset / Trial / NCT00558428

Telmisartan/Amlodipine (80/5) vs. Telmisartan/Amlodipine (40/5) vs. Amlodipine 10 or 5 in Resistant Hypertension

NCT00558428

Phase 3 Completed 1098 enrolled Boehringer Ingelheim
Parallel-groupTreatment

Summary

The primary objectives of this trial are (a) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is superior in reducing blood pressure at eight weeks compared with A5 (b) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is not inferior in reducing blood pressure at eight weeks compared with A10 and (c) to demonstrate that the incidence of oedema on the fixed-dose combination T40/A5 pooled with the fixed-dose combination T80/A5 is superior (less oedema) to A10 in patients who fail to respond adequately to six weeks treatment with A5.

Timeline

Start
2007-10
Primary completion
2008-09
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Amlodipine Other / unclassified 5 mg
Subject Amlodipine Other / unclassified 10 mg
Subject Telmisartan Other / unclassified 40 mg
Subject Telmisartan Other / unclassified 80 mg

Indications