This trial is active, not recruiting.

Condition pulmonary hypertension
Treatment riociguat (adempas, bay63-2521)
Phase phase 3
Sponsor Bayer
Start date July 2009
End date December 2018
Trial size 237 participants
Trial identifier NCT00910429, 11349, 2008-003539-19


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose treatment
Masking no masking
riociguat (adempas, bay63-2521)
BAY63-2521 - 1 mg tid - 2,5 mg tid orally until end of study

Primary Outcomes

Safety and tolerability (e.g. adverse event collection)
time frame: 5 years 2 months and 14 days

Secondary Outcomes

Change in 6-Minute Walking Distance (6MWD) from baseline
time frame: 5 years 2 months and 14 days

Eligibility Criteria

All participants from 18 years up to 80 years old.

Inclusion Criteria: - Patients who have completed 16 weeks of treatment in the double blind trial CHEST 1 Exclusion Criteria: - 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.

Additional Information

Official title Long-term Extension, Multicentre, Multi-international Study to Evaluate the Safety and Tolerability of Oral BAY63-2521 (1mg, 1.5 mg, 2.0 mg, 2.5 mg Tid) in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Bayer.