Clinical trial NCT00159861: The Efficacy and Safety of Sildenafil Citrate Used in Combination With Intravenous Epoprostenol in PAH
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2005-09-12
Enrollment: 267
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Determination of the effects of sildenafil citrate and epoprostenol when used in combination in patients with pulmonary arterial hypertension


Eligibility 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

Primary outcomes:
measure: Categorized Change From Baseline in 6-Minute Walking Distance
timeFrame: 1 Year, 2 Year, 3 Year
Secondary outcomes:
measure: Survival Status
timeFrame: 1, 2, 3, 4, and 5 years
measure: Change in Pulmonary Hypertension Criteria for Functional Capacity and Therapeutic Class
timeFrame: 1 Year, 2 Year, 3 Year
measure: Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36)
timeFrame: Baseline, Month 15, Month 27, Month 39
measure: Change From Baseline in European Quality of Life Scale (EuroQol) 5-Dimensions (EQ-5D): Utility Index Score
timeFrame: Baseline, Month 15, Month 27, Month 39
measure: Change From Baseline in European Quality of Life (EuroQol) Visual Analogue Scale (EQ-5D VAS): Current Health State Score
timeFrame: Baseline, Month 15, Month 27, Month 39
measure: Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36): Reported Health Transition Score
timeFrame: Baseline, Month 15, Month 27, Month 39
measure: Change From Baseline in BORG Dyspnea Score
timeFrame: 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
Other outcomes:
measure: Change in Epoprostenol Dose From Baseline Maintained for 6 Months
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Month 9, and at 3-month intervals through Month 69
Locations:
city: La Jolla
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Torrance
country: United States
facility: Pfizer Investigational Site
state: California
city: Torrance
country: United States
facility: Pfizer Investigational Site
state: California
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Providence
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Ottawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Prague 2
country: Czechia
facility: Pfizer Investigational Site
city: Kobenhavn
country: Denmark
facility: Pfizer Investigational Site
city: Clamart Cedex
country: France
facility: Pfizer Investigational Site
city: Grenoble Cedex 09
country: France
facility: Pfizer Investigational Site
city: Vandoeuvre Les Nancy
country: France
facility: Pfizer Investigational Site
city: Petach Tikva
country: Israel
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Nieuwegein
country: Netherlands
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Papworth Everard
country: United Kingdom
facility: Pfizer Investigational Site
state: Cambridgeshire
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Simonneau G, Rubin LJ, Galie N, Barst RJ, Fleming TR, Frost A, Engel P, Kramer MR, Serdarevic-Pehar M, Layton GR, Sitbon O, Badesch DB; PACES Study Group. Long-term sildenafil added to intravenous epoprostenol in patients with pulmonary arterial hypertension. J Heart Lung Transplant. 2014 Jul;33(7):689-97. doi: 10.1016/j.healun.2014.02.019. Epub 2014 Feb 22.