NCT00159887CompletedPhase 3
A Multi-Centre, Multinational, Long-Term Extension Study, to Assess the Safety and Toleration of Subject Optimised Treatment Regimens of Oral Sildenafil Citrate for Pulmonary Arterial Hypertension in Subjects Who Have Completed Study A1481140.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.66 sites in 16 countries260 target enrollmentStarted: December 1, 2002Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 260
- Locations
- 66
- Primary Endpoint
- Safety
Study Overview
Brief Summary
Open label extension study to the pivotal efficacy study to assess the safety of sildenafil citrate in patients with pulmonary arterial hypertension
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with PAH who had completed the 12 week pivotal study
Exclusion Criteria
- •Any other patients with PAH that had not been included into the pivotal study
Outcomes
Primary Outcomes
Safety
Standard safety data
Efficacy
BORG Dyspnoea Score
6-Minute Walk Test
WHO Functional Class
Quality of Life SF-36 and EQ-5D
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (66)
Loading locations...
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