Trial Condition(s):
Pulmonary arterial hypertension
Efficacy of Ventavis used in real-life setting. (SPHERA)
Bayer Identifier:
15308
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
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.
Inclusion Criteria
- Pulmonary arterial hypertension in WHO functional class III or IV - Age 18+ - Patients newly treated with Ventavis or switched from sildenafil
Exclusion Criteria
- Retrospective documentation is not allowed
Trial Summary
Enrollment Goal
55
Trial Dates
Phase
4
Could I receive a placebo?
No
Products
Ventavis (Iloprost, BAYQ6256)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Poland | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
The efficacy of inhaled iloprost in patients treated within the “Pulmonary Arterial Hypertension Therapeutic Programme”.
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Changes of the exercise capacity as measured by 6-minutes walking distanceTimeframe: 3, 6, 9 and 12 months vs. baseline
Secondary Outcome
- Changes of depression score over timeTimeframe: 3, 6, 9 and 12 months vs. baseline
- Changes of functional capacity as measured by WHO classification systemTimeframe: 3, 6, 9 and 12 months vs. baseline
- Changes of pulmonary haemodynamicsTimeframe: 3, 6, 9 and 12 months vs. baseline
- Changes of serum level of natriuretic peptide BTimeframe: 3, 6, 9 and 12 months vs. baseline
- Changes of Quality of Life scoreTimeframe: 3, 6, 9 and 12 months vs. baseline
- Changes in cardiac echo parametersTimeframe: 3, 6, 9 and 12 months vs. baseline
- Number of patients with treatment-emergent adverse eventsTimeframe: Up to 12 months
Additional Information
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