check_circleStudy Completed
Pulmonary Hypertension
Bayer Identifier:
14990
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Inhaled Iloprost in the treatment of patients with pulmonary hypertension up to 4 years
Trial purpose
This is an open-label, uncontrolled, prospective long-term observation of Specific Drug in the treatment of patients with pulmonary hypertension up to 4 years. 160 patients with primary (idiopathic and familial) pulmonary hypertension (PH) or pulmonary arterial hypertension (PAH) due to scleroderma with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV planned to enroll. Efficacy, safety and tolerability of the drug and the survival of the patients will be observed.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
118Trial Dates
February 2011 - June 2018Phase
N/ACould I Receive a placebo
NoProducts
Ventavis (Iloprost, BAYQ6256)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations | Many Locations, Turkey |
Primary Outcome
- 6 Minutes walking distance (change in meters)date_rangeTime Frame:At month 48enhanced_encryptionNoSafety Issue:
- Adverse events, weight, vital findingsdate_rangeTime Frame:At month 48enhanced_encryptionYesSafety Issue:
Secondary Outcome
- 6 Minutes walking distance (% change)date_rangeTime Frame:At month 48enhanced_encryptionNoSafety Issue:
- New York Heart Association Functional Classdate_rangeTime Frame:At month 48enhanced_encryptionNoSafety Issue:
- Change in drug dosage or frequency, need for PAH specific drug combination, need for drug changedate_rangeTime Frame:At month 48enhanced_encryptionNoSafety Issue:
- Pulmonary hypertension related hospitalizationdate_rangeTime Frame:At month 48enhanced_encryptionNoSafety Issue:
- Heart and/or lung transplantation, mortalitydate_rangeTime Frame:At month 48enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A