The Efficacy and Safety of Sildenafil Citrate Used in Combination With Intravenous Epoprostenol in PAH

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2021
• Main ID: NCT00159861
• Date of registration: 08/09/2005
• Prospective Registration: No
• Primary sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Public title: The Efficacy and Safety of Sildenafil Citrate Used in Combination With Intravenous Epoprostenol in PAH
• Scientific title: A Multinational, Multi-Center, Randomised, Double-Bind, Placebo-Controlled, Parallel Group Study to Assess the Safety and Efficacy of a Subject Optimised Dose of Sildenafil Citrate (20, 40, or 80 mg. Sildenafil Citrate TID) Based on the Toleration, When Used in Combination With Intravenous Prostacyclin( Epoprostenol) in the Treatment of Pulmonary Arterial Hypertension.
• Date of first enrolment: July 2003
• Target sample size: 267
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00159861
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
• Phase: Phase 3

Countries of recruitment

Belgium, Canada, Czech Republic, Czechia, Denmark, France, Israel, Italy, Netherlands, Spain, United Kingdom, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with pulmonary arterial hypertension caused by primary PAH, associated with
connective tissue disease or following surgical repair of a congenital heart lesion

Exclusion Criteria:

- PH other than PAH



Age minimum: 16 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Hypertension

Intervention(s)

Drug: Sildenafil citrate

Primary Outcome(s)

Categorized Change From Baseline in 6-Minute Walking Distance [Time Frame: 1 Year, 2 Year, 3 Year]

Secondary Outcome(s)

Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36) [Time Frame: Baseline, Month 15, Month 27, Month 39]

Survival Status [Time Frame: 1, 2, 3, 4, and 5 years]

Change From Baseline in European Quality of Life Scale (EuroQol) 5-Dimensions (EQ-5D): Utility Index Score [Time Frame: Baseline, Month 15, Month 27, Month 39]

Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36): Reported Health Transition Score [Time Frame: Baseline, Month 15, Month 27, Month 39]

Change From Baseline in BORG Dyspnea Score [Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36]

Change From Baseline in European Quality of Life (EuroQol) Visual Analogue Scale (EQ-5D VAS): Current Health State Score [Time Frame: Baseline, Month 15, Month 27, Month 39]

Change in Pulmonary Hypertension Criteria for Functional Capacity and Therapeutic Class [Time Frame: 1 Year, 2 Year, 3 Year]

Secondary ID(s)

A1481141

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pfizer

Results

• Results available: Yes
• Date Posted: 12/01/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00159861