drugset / Trial / NCT01065454
A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The aim of this study is to assess whether increasing oral doses of Riociguat are safe and improve the well-being, symptoms and outcome in patients with pulmonary hypertension associated with left ventricular systolic dysfunction
Timeline
- Start
- 2010-04-14
- Primary completion
- 2012-06-06
- Completion
- 2025-07-23
Publications
- Results Ghio S, Bonderman D, Felix SB, Ghofrani HA, Michelakis ED, Mitrovic V, Oudiz RJ, Frey R, Roessig L, Semigran MJ. Left ventricular systolic dysfunction associated with pulmonary hypertension riociguat trial (LEPHT): rationale and design. Eur J Heart Fail. 2012 Aug;14(8):946-53. doi: 10.1093/eurjhf/hfs071. Epub 2012 Jun 20.
- Results Bonderman D, Ghio S, Felix SB, Ghofrani HA, Michelakis E, Mitrovic V, Oudiz RJ, Boateng F, Scalise AV, Roessig L, Semigran MJ; Left Ventricular Systolic Dysfunction Associated With Pulmonary Hypertension Riociguat Trial (LEPHT) Study Group. Riociguat for patients with pulmonary hypertension caused by systolic left ventricular dysfunction: a phase IIb double-blind, randomized, placebo-controlled, dose-ranging hemodynamic study. Circulation. 2013 Jul 30;128(5):502-11. doi: 10.1161/CIRCULATIONAHA.113.001458. Epub 2013 Jun 17.
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 |