check_circleStudy Completed
Pulmonary arterial hypertension
Bayer Identifier:
15308
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Efficacy of Ventavis used in real-life setting.
Trial purpose
This is a registry of patients diagnosed with pulmonary arterial hypertension, scheduled for treatment with Ventavis.
Typical clinical measures and quality of life will be prospectively followed in 12 months period.
Typical clinical measures and quality of life will be prospectively followed in 12 months period.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
55Trial Dates
August 2010 - September 2016Phase
Phase 4Could I Receive a placebo
NoProducts
Ventavis (Iloprost, BAYQ6256)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Poland |
Primary Outcome
- Changes of the exercise capacity as measured by 6-minutes walking distancedate_rangeTime Frame:3, 6, 9 and 12 months vs. baselineenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Changes of depression score over timedate_rangeTime Frame:3, 6, 9 and 12 months vs. baselineenhanced_encryptionNoSafety Issue:
- Changes of functional capacity as measured by WHO classification systemdate_rangeTime Frame:3, 6, 9 and 12 months vs. baselineenhanced_encryptionNoSafety Issue:
- Changes of pulmonary haemodynamicsdate_rangeTime Frame:3, 6, 9 and 12 months vs. baselineenhanced_encryptionNoSafety Issue:
- Changes of serum level of natriuretic peptide Bdate_rangeTime Frame:3, 6, 9 and 12 months vs. baselineenhanced_encryptionNoSafety Issue:
- Changes of Quality of Life scoredate_rangeTime Frame:3, 6, 9 and 12 months vs. baselineenhanced_encryptionNoSafety Issue:
- Changes in cardiac echo parametersdate_rangeTime Frame:3, 6, 9 and 12 months vs. baseline
- Number of patients with treatment-emergent adverse eventsdate_rangeTime Frame:Up to 12 months
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A