Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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8 February 2021 |
Main ID: |
NCT00159861 |
Date of registration:
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08/09/2005 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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The Efficacy and Safety of Sildenafil Citrate Used in Combination With Intravenous Epoprostenol in PAH
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Scientific title:
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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:
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July 2003 |
Target sample size:
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267 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT00159861 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
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Phase:
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Phase 3
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Countries of recruitment
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Belgium
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Canada
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Czech Republic
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Czechia
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Denmark
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France
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Israel
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Italy
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Netherlands
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Spain
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United Kingdom
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Pulmonary Hypertension
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Intervention(s)
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Drug: Sildenafil citrate
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Primary Outcome(s)
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Categorized Change From Baseline in 6-Minute Walking Distance
[Time Frame: 1 Year, 2 Year, 3 Year]
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Secondary Outcome(s)
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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]
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Change in Pulmonary Hypertension Criteria for Functional Capacity and Therapeutic Class
[Time Frame: 1 Year, 2 Year, 3 Year]
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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]
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Survival Status
[Time Frame: 1, 2, 3, 4, and 5 years]
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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]
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Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36)
[Time Frame: Baseline, Month 15, Month 27, Month 39]
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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