Trials / Completed
CompletedNCT00863681
BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial Hypertension
Long-term Extension, Multicentre, Multi-national 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 Symptomatic Pulmonary Arterial Hypertension (PAH)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 396 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Patients who have completed the 12 weeks treatment of the PATENT-1 trial (study number 12934) will be asked to participate in this long term extension study with BAY63-2521.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Riociguat (BAY63-2521) | BAY63-2521: 1mg tid -2.5 mg tid oral until end of study |
Timeline
- Start date
- 2009-03-12
- Primary completion
- 2019-08-19
- Completion
- 2019-08-19
- First posted
- 2009-03-18
- Last updated
- 2023-11-07
- Results posted
- 2020-10-22
Locations
99 sites across 27 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Greece, Italy, Japan, Mexico, Poland, Portugal, Russia, Singapore, South Korea, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT00863681. Inclusion in this directory is not an endorsement.