ong-term study to collect additional information to evaluate the safetyand tolerability of BAY 63-2521 in different doses

Phase 1

• Conditions: Pulmonary Arterial Hypertension (PAH); MedDRA version: 15.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2008-003610-94-DE
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-31
• Last Update Posted: 29 April 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 462

Inclusion Criteria

• 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

Exclusion Criteria

•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