Phase 3
Completed N=445
A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)
Source: ClinicalTrials.gov NCT00810693 ↗Enrolled (actual)
445
Serious AEs
14.2%
Results posted
Feb 2014
Primary outcomePrimary: 6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 12 — 29.6; 31.1; -5.6 Meters — p=<0.0001
Summary
The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521 given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension (PAH).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 12 |
29.6; 31.1; -5.6 | <0.0001 sig |
| SECONDARY Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 12 |
-223.29; -167.79; -8.89 | <0.0001 sig |
| SECONDARY N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 12 |
-197.89; -471.50; 232.39 | <0.0001 sig |
| SECONDARY World Health Organization (WHO) Functional Class - Change From Baseline to Week 12 |
0.4; 0; 0; 20.5; 23.8; 14.4 | 0.0033 sig |
| SECONDARY Percentage of Participants With Clinical Worsening |
1.2; 3.2; 6.3; 0.4; 0; 3.2 | 0.0046 sig |
| SECONDARY Borg CR 10 Scale - Change From Baseline to Week 12 |
-0.44; -0.33; 0.09 | 0.0022 sig |
| SECONDARY EQ-5D Utility Score - Change From Baseline to Week 12 |
0.0329; 0.0782; -0.0317 | 0.0663 |
| SECONDARY Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 12 |
-5.99; -10.21; 0.36 | 0.0019 sig |
Eligibility Criteria
Inclusion Criteria
- Male and female patients with symptomatic PAH (Idiopathic, Familial, Associated PAH due to connective tissue disease, congenital heart disease, portal hypertension with liver cirrhosis, or due to anorexigen or amphetamine use)
- Treatment naive patients and patients pre-treated with an Endothelin Antagonist or a Prostacyclinanalogue (except I.V.).
Exclusion Criteria
- All types of pulmonary hypertension except subtypes of Venice Group I specified in the inclusion criteria, severe COPD (chronic obstructive pulmonary disease), uncontrolled arterial hypertension, left heart failure.
Data sourced from ClinicalTrials.gov (NCT00810693). 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. Informational only — not medical advice.