ong-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63 2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2
- Conditions
- Pulmonary Arterial Hypertension (PAH)MedDRA version: 9.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension
- Registration Number
- EUCTR2008-003610-94-FR
- 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
• 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, or breast feeding women, or women with childbearing
potential not using a combination of condoms and a safe and highly effective
contraception method (hormonal contraception with implants or combined oral
contraceptives, certain IUDs).
• 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.
• 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 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): The objective of the trial is to assess safety and tolerability of long-term treatment of BAY 63 2521 in patients with symptomatic PAH. In addition, efficacy assessments are included to provide an indication of maintenance of efficacy with long term treatment.
- Secondary Outcome Measures
Name Time Method