At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 396 enrolled
Drug / intervention
Riociguat (BAY63-2521)drug
Likely dose
Riociguat (BAY63-2521) 1mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Riociguat (BAY63-2521) for Hypertension, Pulmonary. Completed, enrolled 396 participants across 99 sites in 27 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension, Pulmonary
CountriesArgentina, 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, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2009
First PostedMar 2009
Primary CompletionAug 2019
TodayJul 2026
First PostedMar 18, 2009
Enrollment StartMar 12, 2009
Primary CompletionAug 19, 2019
TodayJul 2, 2026
Enrollment to primary: 10.4 yearsPosted 17.3 years ago
Interventions
Riociguat (BAY63-2521)drug
BAY63-2521: 1mg tid -2.5 mg tid oral until end of study