ong-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 in different doses
- Conditions
- Pulmonary Arterial Hypertension (PAH)MedDRA version: 18.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2008-003610-94-BE
- Lead Sponsor
- Bayer HealthCare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 462
• Patients who have completed 12 weeks of treatment in the double blind trial
PATENT-1.
• Patients must have given their written informed consent to participate in the
study after having received adequate previous information and prior to any
study-specific procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Patient’s participating in another clinical trial
•Patients who have an ongoing serious adverse event from PATENT-1 that is
assessed as related to BAY 63-2521 are not allowed to participate in the
extension trial.
• Pregnant women(i.e. positive serum ß-human-chorionic-gonadotropin test or other signs of pregnancy) or breast feeding women, or or women with childbearing potential not using a combination of safe contraception methods
• Patients with a medical disorder, condition, or history of such that would impair
the patient's ability to participate or complete this study in the opinion of the
investigator or the sponsor.
• Pertinent non compliance with the conditions for the trial or instructions by the investigator during PATENT-1 participation.
• Patients with hypersensitivity to the investigational drug or inactive
constituents.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Until end of the trial;Main Objective: to evaluate the long-term safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in in treatment naive patients and patients pretreated with an Endothelin Receptor Antagonist or a Prostacyclinanalogue with symptomatic Pulmonary Arterial Hypertension (PAH);Secondary Objective: ;Primary end point(s): Safety (adverse events collection) and tolerability will be assessed in the long term treatment (until end of trial)
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): To provide an indication of maintenance of efficacy with long term treatment the following assessment are included:<br> - change from baseline in 6 Minute walking distance <br> - change from baseline in WHO functional class <br> - Time to Clincal Worsening<br> <br> ;Timepoint(s) of evaluation of this end point: Until end of the trial