A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH.

Completed · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Hypertension

In brief

The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521, given orally for 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH).

Key facts

Study ID

NCT00855465

Run by

Bayer

People needed

262

Starts

2009-02-23

Expected to finish

2012-06-27

Last updated by the study team

2023-11-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients with CTEPH either inoperable or with persistent or recurrent PH after surgery.

You may not qualify if…

• All types of pulmonary hypertension except subtypes 4.1 and 4.2 of the Venice Clinical Classification of Pulmonary Hypertension.

Where it is running

• Study site — Sacramento, California, United States
• Study site — Miami, Florida, United States
• Study site — Iowa City, Iowa, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Cleveland, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Dallas, Texas, United States
• Study site — Corrientes, Argentina
• Study site — Prahran, Victoria, Australia
• Study site — Innsbruck, Austria
• Study site — Vienna, Austria
• Study site — Bruxelles - Brussel, Belgium
• Study site — Leuven, Belgium
• Study site — Porto Alegre, Rio Grande do Sul, Brazil
• Study site — São Paulo, São Paulo, Brazil
• Study site — Rio de Janeiro, Brazil
• Study site — Calgary, Alberta, Canada
• Study site — London, Ontario, Canada
• Study site — Ottawa, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Qingdao, Shandong, China
• Study site — Beijing, China
• Study site — La Jolla, California, United States

Full record on ClinicalTrials.gov

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