Fixed Dose Combination of Bisoprolol and Amlodipine in the Treatment of Hypertension

NCT01977794 ↗

Phase 3 Completed 200 enrolled Merck KGaA, Darmstadt, Germany

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, comparative Phase 3 trial to investigate the efficacy of fixed dose combination (FDC) of bisoprolol and amlodipine in hypertensive subjects (superiority of FDC over monotherapies).

Timeline

Start: 2014-03
Primary completion: 2015-03
Completion: 2015-03

Outcome

Met primary endpoint

paper bisoprolol monotherapy failure: 25.9 ± 12.82 mmHg reduction; amlodipine monotherapy failure: 24.7 ± 11.67 mmHg reduction; p < 0.001 for both). PMID 27334671 ↗

Publications

Gottwald-Hostalek U, Li L, Montenegro P. Bisoprolol/amlodipine combination therapy improves blood pressure control in patients with essential hypertension following monotherapy failure. Curr Med Res Opin. 2016 Oct;32(10):1735-1743. doi: 10.1080/03007995.2016.1205573. Epub 2016 Jul 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amlodipine	Other / unclassified	5 mg	Oral
Subject	Amlodipine	Other / unclassified	10 mg	Oral
Subject	Bisoprolol	Other / unclassified	5 mg	Oral
Subject	Bisoprolol	Other / unclassified	10 mg	Oral