Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national Study to Evaluate the Efficacy and Safety of Oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg Tid) in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 262
- Locations
- 2
- Primary Endpoint
- 6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 16
Study Overview
Brief Summary
The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521, given orally for 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
Detailed Description
Adverse event data will be covered in Adverse events section.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female patients with CTEPH either inoperable or with persistent or recurrent PH after surgery.
Exclusion Criteria
- •All types of pulmonary hypertension except subtypes 4.1 and 4.2 of the Venice Clinical Classification of Pulmonary Hypertension.
Arms & Interventions
Riociguat (Adempas, BAY63-2521)_individual dose titration
Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
Intervention: Riociguat (Adempas, BAY63-2521) (Drug)
Placebo
Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 16
Time Frame: Baseline and week 16
6-minute walking distance (6MWD) is a measure for the objective evaluation of a participant's functional exercise capacity.
Secondary Outcomes
- Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16(Baseline and week 16)
- Percentage of Participants With Clinical Worsening(At week 16)
- Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 16(Baseline and week 16)
- N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 16(Baseline and week 16)
- World Health Organization (WHO) Functional Class - Change From Baseline to Week 16(Baseline and week 16)
- Borg CR 10 Scale - Change From Baseline to Week 16(Baseline and week 16)
- EQ-5D Utility Score - Change From Baseline to Week 16(Baseline and week 16)