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
Conditions
Interventions
Product Name: BAY 63-2521 tablets 0.5 mg
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: riociguat
Sponsors
Bayer HealthCare AG, Bayer Vital GmbH, D-51368 Leverkusen
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: ;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. | — |
Countries
Austria, Belgium, Czech Republic, Denmark, France, Germany, Ireland, Italy, Netherlands, Portugal, Slovakia, Spain, United Kingdom
Outcome results
None listed