Estudio de extensión a largo plazo, multicéntrico y multinacional, para evaluar la seguridad y tolerabilidad de BAY 63 2521 (1 mg, 1,5 mg, 2 mg o 2,5 mg tid) administrado por vía oral, en pacientes con Hipertensión Arterial Pulmonar (HAP) sintomática. Estudio PATENT-2 - PATENT-2

• Conditions: Hipertensión Arterial Pulmonar Sintomática; MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-29
• Last Update Posted: 17 July 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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

? 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