BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension

Completed · Phase 3

Conditions studied: Pulmonary Hypertension

In brief

Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348) will be asked to participate in this long term extension study with BAY63-2521. The aim of the long term study is to collect additional information to evaluate the safety and tolerability of BAY63-2521. Patients will be treated with open label medication on their individual optimal dose between 0,5 mg - 2,5 mg tid.

Key facts

Study ID

NCT00910429

Run by

Bayer

People needed

237

Starts

2009-07-01

Expected to finish

2019-08-19

Last updated by the study team

2023-11-07

Who can join

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

You may qualify if…

• Patients who have completed 16 weeks of treatment in the double blind trial CHEST 1

You may not qualify if…

• Patients who have an ongoing serious adverse event from CHEST 1 that is assessed as related to BAY63-2521 are not allowed to participate in the extension trial

Where it is running

• Study site — Sacramento, California, 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 — 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 — Beijing, China
• Study site — Beijing, China
• Study site — Shanghai, China
• Study site — Prague, Czechia
• Study site — La Jolla, California, United States

Full record on ClinicalTrials.gov

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