Pulmonary Arterial Hypertension (PAH) MedDRA version: 15.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: •Patient’s participating in another clinical trial •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(i.e. positive serum ß-human-chorionic-gonadotropin test or other signs of pregnancy) or breast feeding women, or or women with childbearing potential not using a combination of safe contraception methods • 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 PATENT-1 participation. • Patients with hypersensitivity to the investigational drug or inactive constituents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the long-term safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in in treatment naive patients and patients pretreated with an Endothelin Receptor Antagonist or a Prostacyclinanalogue with symptomatic Pulmonary Arterial Hypertension (PAH);Secondary Objective: ;Primary end point(s): Safety (adverse events collection) and tolerability will be assessed in the long term treatment (until end of trial) ;Timepoint(s) of evaluation of this end point: Until end of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To provide an indication of maintenance of efficcacy with long term tretatment the following assessment are included: - change from baseline in 6 Minute walking distance - change from baseline in NT-proBNP - change from baseline in WHO functional class - Time to Clincal Worsening - change from baseline in Borg CR10 Scale - change from baseline in EQ-5D questionnarie - change from baseline in LPH questionnarie Additional HEOR endpoints: - change in use of healthcare resources ;Timepoint(s) of evaluation of this end point: Until end of the trial | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Poland, Portugal, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States
Contacts
Public ContactBayer Clinical Trials Contact
Bayer HealthCare AG
Outcome results
None listed