drugset / Trial / NCT01975246

Add-on to Micamlo BP Trial

NCT01975246

Phase 3 Completed 309 enrolled Boehringer Ingelheim
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a multi-centre, randomised, double-blind, active-controlled, parallel-group comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg +hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+ amlodipine 5 mg (T80/A5 mg) in blood pressure lowering effect at week 8, the end of the double-blind period in essential hypertensive patients who fail to respond adequately to telmisartan 80 mg+ amlodipine 5 mg. Patients are assigned to one of the two groups after a 6-week open-label run-in period taking T80/A5 mg.

Timeline

Start
2013-11
Primary completion
2014-06
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydrochlorothiazide Unknown 12.5 mg
Comparator Amlodipine Other / unclassified 5 mg
Comparator Telmisartan Other / unclassified 80 mg