NCT01065454

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

Randomized, Double Blind, Placebo Controlled, Parallel Group, Multi-center Study to Evaluate the Hemodynamic Effects of Riociguat (BAY 63-2521) as Well as Safety and Kinetics in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed description

Pharmacokinetics parameters were regarded as exploratory parameters. Adverse event data will be covered in Adverse events section.

Conditions

• Hypertension, Pulmonary
• Ventricular Dysfunction, Left

Interventions

Type	Name	Description
DRUG	Riociguat (Adempas, BAY63-2521)	up to 2 mg three times a day (increasing from 0.5 to 1 to 2 mg)
DRUG	Riociguat (Adempas, BAY63-2521)	up to 1 mg three times a day (increasing from 0.5 to 1 mg)
DRUG	Riociguat (Adempas, BAY63-2521)	fixed 0.5 mg three times a day
DRUG	Placebo	Placebo three times a day

Timeline

• Start date: 2010-04-14
• Primary completion: 2012-06-06
• Completion: 2025-07-23
• First posted: 2010-02-09
• Last updated: 2025-08-28
• Results posted: 2013-12-25

Locations

83 sites across 18 countries: United States, Australia, Austria, Belgium, Canada, China, Czechia, Denmark, France, Germany, Italy, Japan, Netherlands, Poland, Singapore, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study