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

NCT01065454 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2025-08-28

Study results available
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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

Conditions

  • Hypertension, Pulmonary
  • Ventricular Dysfunction, Left

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-14
Primary Completion
2012-06-06
Completion
2025-07-23
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • China
  • Czechia
  • Denmark
  • France
  • Germany
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Singapore
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01065454 on ClinicalTrials.gov