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 Pulmonar Tromboembólica Crónica (HPTEC) Estudio CHEST-2 - CHEST-2
- Conditions
- Hipertensión Pulmonar Tromboembólica Crónica (HPTEC)MedDRA version: 9.1 Level: LLT Classification code 10037406 Term: Pulmonary hypertension secondary
- Registration Number
- EUCTR2008-003539-19-ES
- Lead Sponsor
- Bayer HealthCare AG, Bayer Vital GmbH, D-51368 Leverkusen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 270
Patients who have completed 16 weeks of treatment in the double blind trial CHEST-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 CHEST-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: Long-term safety and tolerability of BAY 63-2521 in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) or recurrent or persisting pulmonary hypertension after surgical treatment.;Secondary Objective: Not Applicable;Primary end point(s): The aim of this long-term extension study is primarily safety and tolerability, so no single primary variable has been identified.
- Secondary Outcome Measures
Name Time Method