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TERMINATED
NCT01065454
PHASE2

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

Sponsor: Bayer

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

202

Start Date

2010-04-14

Completion Date

2025-07-23

Last Updated

2026-08-20

Healthy Volunteers

No

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

Locations (83)

Los Angeles, California, United States

San Diego, California, United States

Torrance, California, United States

Westminster, California, United States

Miami, Florida, United States

Iowa City, Iowa, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Rochester, Minnesota, United States

St Louis, Missouri, United States

Cincinnati, Ohio, United States

Fairfield, Ohio, United States

Falls Church, Virginia, United States

Milwaukee, Wisconsin, United States

Sydney, New South Wales, Australia

Herston, Queensland, Australia

Melbourne, Victoria, Australia

Vienna, State of Vienna, Austria

Innsbruck, Tyrol, Austria

Aalst, Belgium

Brussels, Belgium

Ghent, Belgium

Leuven, Belgium

Edmonton, Alberta, Canada

Vancouver, British Columbia, Canada

Montreal, Quebec, Canada

Québec, Quebec, Canada

Beijing, China

Shanghai, China

Shanghai, China

Brno, Czechia

Olomouc, Czechia

Prague, Czechia

Prague, Czechia

Aarhus N, Denmark

Bron, France

Lille, France

Nantes, France

Pessac, France

Rouen, France

Toulouse, France

Heidelberg, Baden-Wurttemberg, Germany

Augsburg, Bavaria, Germany

Greifswald, Mecklenburg-Vorpommern, Germany

Cologne, North Rhine-Westphalia, Germany

Erfurt, Thuringia, Germany

Naples, Campania, Italy

Pavia, Lombardy, Italy

Nagoya, Aichi-ken, Japan

Seto, Aichi-ken, Japan

Ōgaki, Gifu, Japan

Higashiibaraki, Ibaraki, Japan

Tsu, Mie-ken, Japan

Sendai, Miyagi, Japan

Kita-ku, Osaka, Osaka, Japan

Osaka, Osaka, Japan

Suita, Osaka, Japan

Kusatsu, Shiga, Japan

Sunto, Shizuoka, Japan

Arakawa-ku, Tokyo, Japan

Shinjuku-ku, Tokyo, Japan

Tanabe, Wakayama, Japan

Amsterdam, Netherlands

Amsterdam, Netherlands

Nijmegen, Netherlands

Bydgoszcz, Poland

Gdansk, Poland

Warsaw, Poland

Singapore, Singapore

Singapore, Singapore

Singapore, Singapore

A Coruña, A Coruña, Spain

Barcelona, Barcelona, Spain

Madrid, Madrid, Spain

Majadahonda, Madrid, Spain

Murcia, Murcia, Spain

Palma, Palma de Mallorca, Spain

Valencia, Valencia, Spain

Geneva, Canton of Geneva, Switzerland

Zurich, Canton of Zurich, Switzerland

Lugano, Canton Ticino, Switzerland

Cambridge, Cambridgeshire, United Kingdom

London, London, United Kingdom