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

NCT00159861 | Completed Phase 3 Results

• 1 other identifier: A1481141
• Study Type: interventional
• Target: 267
• Locations: 11 countries
• Sites: 52

Brief Summary

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

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Categorized Change From Baseline in 6-Minute Walking Distance

  Number of subjects with categorized change in 6-minute walking distance. Distance that a subject could walk in 6-minutes at a comfortable pace with as many breaks as needed. Performed as close to trough levels of sildenafil as possible (just before dosing; at least 4 hours after the previous dose of study drug). Scores for categorized changes for missing visits were imputed as the worse score of its non-missing neighbors. If a visit was missing and there was no subsequent score, the score was coded to missing.

  1 Year, 2 Year, 3 Year

Secondary Outcomes (7)

• Survival Status

  1, 2, 3, 4, and 5 years

• Change in Pulmonary Hypertension Criteria for Functional Capacity and Therapeutic Class

  1 Year, 2 Year, 3 Year

• Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36)

  Baseline, Month 15, Month 27, Month 39

• Change From Baseline in European Quality of Life Scale (EuroQol) 5-Dimensions (EQ-5D): Utility Index Score

  Baseline, Month 15, Month 27, Month 39

• Change From Baseline in European Quality of Life (EuroQol) Visual Analogue Scale (EQ-5D VAS): Current Health State Score

  Baseline, Month 15, Month 27, Month 39

Other Outcomes (1)

• Change in Epoprostenol Dose From Baseline Maintained for 6 Months

  Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Month 9, and at 3-month intervals through Month 69

Interventions

Sildenafil citrate DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• PH other than PAH

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead
• Pfizer: collaborator

Study Sites (52)

Pfizer Investigational Site

La Jolla, California, 92037, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90033, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90073, United States

Location

Pfizer Investigational Site

San Diego, California, 92103, United States

Location

Pfizer Investigational Site

Torrance, California, 90502, United States

Location

Pfizer Investigational Site

Torrance, California, 90509, United States

Location

Pfizer Investigational Site

Denver, Colorado, 80220, United States

Location

Pfizer Investigational Site

Denver, Colorado, 80262, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60637, United States

Location

Pfizer Investigational Site

Kansas City, Kansas, 66160, United States

Location

Pfizer Investigational Site

New Orleans, Louisiana, 70112, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21287, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02111, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02114, United States

Location

Pfizer Investigational Site

Ann Arbor, Michigan, 48109, United States

Location

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Rochester, Minnesota, 55905, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63110, United States

Location

Pfizer Investigational Site

Omaha, Nebraska, 68105, United States

Location

Pfizer Investigational Site

Omaha, Nebraska, 68198-2125, United States

Location

Pfizer Investigational Site

New York, New York, 10032, United States

Location

Pfizer Investigational Site

Durham, North Carolina, 27710, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45219, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45267-0769, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44195, United States

Location

Pfizer Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

Location

Pfizer Investigational Site

Providence, Rhode Island, 02903, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37232-5735, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37232, United States

Location

Pfizer Investigational Site

Houston, Texas, 77030, United States

Location

Pfizer Investigational Site

Salt Lake City, Utah, 84143, United States

Location

Pfizer Investigational Site

Milwaukee, Wisconsin, 53215, United States

Location

Pfizer Investigational Site

Milwaukee, Wisconsin, 53226, United States

Location

Pfizer Investigational Site

Milwaukee, Wisconsin, 53277, United States

Location

Pfizer Investigational Site

Leuven, 3000, Belgium

Location

Pfizer Investigational Site

Edmonton, Alberta, T6G 2B7, Canada

Location

Pfizer Investigational Site

Ottawa, Ontario, K1Y 4E9, Canada

Location

Pfizer Investigational Site

Ottawa, Ontario, K1Y 4W7, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, M5G 2N2, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H3T 1E2, Canada

Location

Pfizer Investigational Site

Prague, 128 08, Czechia

Location

Pfizer Investigational Site

Copenhagen, 2100, Denmark

Location

Pfizer Investigational Site

Clamart, 92141, France

Location

Pfizer Investigational Site

Grenoble, 38043, France

Location

Pfizer Investigational Site

Vandœuvre-lès-Nancy, France

Location

Pfizer Investigational Site

Petah Tikva, 49100, Israel

Location

Pfizer Investigational Site

Bologna, 40138, Italy

Location

Pfizer Investigational Site

Amsterdam, 1081 HV, Netherlands

Location

Pfizer Investigational Site

Nieuwegein, 3435CM, Netherlands

Location

Pfizer Investigational Site

Barcelona, 08036, Spain

Location

Pfizer Investigational Site

Madrid, 28041, Spain

Location

Pfizer Investigational Site

Papworth Everard, Cambridgeshire, CB3 8RE, United Kingdom

Location

Pfizer Investigational Site

Glasgow, G11 6NT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 24815795 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: July 1, 2003
• Study Completion: January 1, 2006
• Last Updated: February 1, 2021
• Results First Posted: January 12, 2011

Record last verified: 2021-01

Locations

NL (2); CZ (1); IL (1); CA (5); US (33); DK (1); IT (1); ES (2); GB (2); BE (1); FR (3)