CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 237 enrolled
Drug / intervention
Riociguat (Adempas, BAY63-2521)drug
Likely dose
Riociguat (Adempas, BAY63-2521) 1 mgfrom 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.

Search/NCT00910429
NCT00910429Phase 3Completed
CompareCT.gov

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).

Bayer·interventional·Posted May 29, 2009·Updated Nov 7, 2023

In Brief

A Phase 3 clinical trial evaluating Riociguat (Adempas, BAY63-2521) for Pulmonary Hypertension. Completed, enrolled 237 participants across 73 sites in 26 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Hypertension
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Israel, Italy, Japan, Mexico, Poland, Portugal, Russia, Slovakia, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 29, 2009
Enrollment StartJul 1, 2009
Primary CompletionAug 19, 2019
TodayJul 2, 2026
Enrollment to primary: 10.1 yearsPosted 17.1 years ago

Interventions

Riociguat (Adempas, BAY63-2521)drug

BAY63-2521 - 1 mg tid - 2,5 mg tid orally until end of study