A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Diastolic Dysfunction

Phase 2 Terminated 39 enrolled Bayer

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The aim of this study is to assess whether single oral doses of Riociguat safely improve the cardiovascular function in patients with pulmonary hypertension associated with left ventricular diastolic dysfunction

Timeline

Start: 2010-07
Primary completion: 2012-10
Completion: 2012-10

Outcome

Missed primary endpoint

Stopped (Enrollment): “Recruitment was only stopped after the statistical power of the study was reached and the study objectives could be met despite the premature discontinuation.”

paper There was no significant change in peak decrease in mPAP with riociguat 2 mg (n = 10) vs placebo (n = 11, P = .6). PMID 24991733 ↗

Publications

Bonderman D, Pretsch I, Steringer-Mascherbauer R, Jansa P, Rosenkranz S, Tufaro C, Bojic A, Lam CSP, Frey R, Ochan Kilama M, Unger S, Roessig L, Lang IM. Acute hemodynamic effects of riociguat in patients with pulmonary hypertension associated with diastolic heart failure (DILATE-1): a randomized, double-blind, placebo-controlled, single-dose study. Chest. 2014 Nov;146(5):1274-1285. doi: 10.1378/chest.14-0106.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Riociguat	Other / unclassified	0.5 mg	Oral
Subject	Riociguat	Other / unclassified	1 mg	Oral
Subject	Riociguat	Other / unclassified	2 mg	Oral