Study to Assess the Longterm Safety of Sildenafil Citrate in Patients With Pulmonary Arterial Hypertension

NCT ID: NCT00159887

Last Updated: 2021-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2007-02-28

Brief Summary

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Open label extension study to the pivotal efficacy study to assess the safety of sildenafil citrate 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

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Sildenafil citrate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with PAH who had completed the 12 week pivotal study

Exclusion Criteria

* Any other patients with PAH that had not been included into the pivotal study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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La Jolla, California, United States

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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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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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Denver, Colorado, United States

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Denver, Colorado, United States

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Chicago, Illinois, United States

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Baltimore, Maryland, 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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New York, New York, United States

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Durham, North Carolina, 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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Milwaukee, Wisconsin, United States

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Darlinghurst, New South Wales, Australia

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Melbourne, Victoria, Australia

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Brussels, , Belgium

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Leuven, , Belgium

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São Paulo, São Paulo, Brazil

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Prague, , Czechia

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Prague, , Czechia

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Copenhagen, , Denmark

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Clamart, , France

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Giessen, , Germany

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Hanover, , Germany

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Leipzig, , Germany

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Shatin NT, , Hong Kong

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Budapest, , Hungary

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Zalaegerszeg, , Hungary

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Petah Tikva, , Israel

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Tel Litwinsky, , Israel

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Bologna, , Italy

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Pisa, , Italy

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Pisa, , Italy

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Kuala Lumpur, , Malaysia

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Petaling Jaya, , Malaysia

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Tlalpan Mexico, Mexico City, Mexico

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Tlalpan, Mexico DF, Mexico

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Amsterdam, , Netherlands

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Warsaw, , Poland

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Zabrze, , Poland

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Singapore, , Singapore

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Parow, Western Cape, South Africa

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Parktown, , South Africa

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Parktown West, , South Africa

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Suwon, , South Korea

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Barcelona, , Spain

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Barcelona, , Spain

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Madrid, , Spain

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Gothenburg, , Sweden

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Papworth Everard, Cambridgeshire, United Kingdom

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Sheffield, South Yorkshire, United Kingdom

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Newcastle upon Tyne, Tyne and Wear, United Kingdom

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Cambridge, , United Kingdom

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Glasgow, , United Kingdom

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Countries

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United States Australia Belgium Brazil Czechia Denmark France Germany Hong Kong Hungary Israel Italy Malaysia Mexico Netherlands Poland Singapore South Africa South Korea Spain Sweden United Kingdom

References

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Wirostko BM, Tressler C, Hwang LJ, Burgess G, Laties AM. Ocular safety of sildenafil citrate when administered chronically for pulmonary arterial hypertension: results from phase III, randomised, double masked, placebo controlled trial and open label extension. BMJ. 2012 Feb 21;344:e554. doi: 10.1136/bmj.e554.

Reference Type DERIVED
PMID: 22354598 (View on PubMed)

Rubin LJ, Badesch DB, Fleming TR, Galie N, Simonneau G, Ghofrani HA, Oakes M, Layton G, Serdarevic-Pehar M, McLaughlin VV, Barst RJ; SUPER-2 Study Group. Long-term treatment with sildenafil citrate in pulmonary arterial hypertension: the SUPER-2 study. Chest. 2011 Nov;140(5):1274-1283. doi: 10.1378/chest.10-0969. Epub 2011 May 5.

Reference Type DERIVED
PMID: 21546436 (View on PubMed)

Related Links

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Other Identifiers

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A1481142

Identifier Type: -

Identifier Source: org_study_id

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