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 Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-2

Phase 1

• Conditions: Chronic Thromboembolic Pulmonary Hypertention; MedDRA version: 13.1 Level: LLT Classification code 10037406 Term: Pulmonary hypertension secondary System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

• Registration Number: EUCTR2008-003539-19-NL
• Lead Sponsor: Bayer HealthCare AG, Bayer Vital GmbH, D-51368 Leverkusen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-30
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 270

Inclusion Criteria

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

Exclusion Criteria

Patient’s participating in another clinical trial

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 (i.e. positive serum ß-human-chorionic-gonadotropin test or other signs of pregnancy) or breast feeding women, or women with childbearing potential not using a combination of safe contraception methods throughout the study.

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 CHEST-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