Phase 3
N=262
A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH.
Pulmonary Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00855465 ↗Enrolled (actual)
262
Serious AEs
18.4%
Results posted
Mar 2014
Primary outcome: Primary: 6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 16 — 38.9; -5.5 Meters — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Riociguat (Adempas, BAY63-2521) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 16 |
38.9; -5.5 | <0.0001 sig |
| SECONDARY Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16 |
-225.68; 23.07 | <0.0001 sig |
| SECONDARY N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 16 |
-290.69; 76.35 | <0.0001 sig |
| SECONDARY World Health Organization (WHO) Functional Class - Change From Baseline to Week 16 |
2.3; 0; 30.6; 14.9; 61.8; 78.2 | 0.0026 sig |
| SECONDARY Percentage of Participants With Clinical Worsening |
2.3; 5.7; 0; 1.1; 1.2; 1.1 | 0.1724 |
| SECONDARY Borg CR 10 Scale - Change From Baseline to Week 16 |
-0.83; 0.17 | 0.0035 sig |
| SECONDARY EQ-5D Utility Score - Change From Baseline to Week 16 |
0.0615; -0.0819 | <0.0001 sig |
| SECONDARY Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 16 |
-6.72; -2.09 | 0.1220 |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00855465). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.