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

Phase 1

Conditions: Chronic Thromboembolic Pulmonary Hypertension
MedDRA version: 19.0Level: LLTClassification code 10037406Term: Pulmonary hypertension secondarySystem Organ Class: 100000004855
Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

Registration Number: EUCTR2008-003539-19-SK

Lead Sponsor: Bayer AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 170

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

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.;Timepoint(s) of evaluation of this end point: Last visit of last subject

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Change from baseline in 6 Minute Walking Distance<br>-Change from baseline in NT-pro BNP<br>-Change from baseline in WHO functional class<br>-Time To Clinical Worsening<br>-Change from baseline in Borg CR 10 Scale or Modified Borg Dyspnoea Scale (if patients were enrolled in trial 11348 before amendment 3 approval in their countries) measured at the end of the 6MWD Test<br>-Change from baseline in EQ-5D questionnaire<br>-Change from baseline in LPH questionnaire<br>-Change in use of healthcare resources<br>;Timepoint(s) of evaluation of this end point: Last visit of last subject