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

NCT ID: NCT00159861

Last Updated: 2021-02-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

267 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2006-01-31

Brief Summary

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

Detailed Description

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Conditions

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Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Interventions

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Sildenafil citrate

Intervention Type DRUG

Eligibility 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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

La Jolla, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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San Diego, California, United States

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Torrance, California, United States

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Torrance, California, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Chicago, Illinois, United States

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Kansas City, Kansas, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Rochester, Minnesota, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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New York, New York, United States

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Durham, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Pittsburgh, Pennsylvania, United States

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Providence, Rhode Island, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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Salt Lake City, Utah, United States

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Milwaukee, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Leuven, , Belgium

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Edmonton, Alberta, Canada

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Ottawa, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Prague, , Czechia

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Copenhagen, , Denmark

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Clamart, , France

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Grenoble, , France

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Vandœuvre-lès-Nancy, , France

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Petah Tikva, , Israel

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Bologna, , Italy

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Amsterdam, , Netherlands

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Nieuwegein, , Netherlands

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Barcelona, , Spain

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Madrid, , Spain

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Papworth Everard, Cambridgeshire, United Kingdom

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Glasgow, , United Kingdom

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Countries

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

References

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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.

Reference Type DERIVED
PMID: 24815795 (View on PubMed)

Related Links

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Other Identifiers

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A1481141

Identifier Type: -

Identifier Source: org_study_id

NCT00147641

Identifier Type: -

Identifier Source: nct_alias

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