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

NCT00159887 | Completed Phase 3

• 1 other identifier: A1481142
• Study Type: interventional
• Target: 260
• Locations: 22 countries
• Sites: 65

Brief Summary

Open label extension study to the pivotal efficacy study to assess the safety of sildenafil citrate in patients with pulmonary arterial hypertension

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (7)

• Safety

• Standard safety data

• Efficacy

• 6-Minute Walk Test

• BORG Dyspnoea Score

• WHO Functional Class

• Quality of Life SF-36 and EQ-5D

Interventions

Sildenafil citrate DRUG

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Any other patients with PAH that had not been included into the pivotal study

Sponsors & Collaborators

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

Study Sites (65)

Pfizer Investigational Site

Birmingham, Alabama, 35233, United States

Location

Pfizer Investigational Site

Birmingham, Alabama, 35294-0006, United States

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Pfizer Investigational Site

Birmingham, Alabama, 35294, United States

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Pfizer Investigational Site

La Jolla, California, 92037, United States

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La Jolla, California, 92093, United States

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Los Angeles, California, 90024, United States

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Los Angeles, California, 90033, United States

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Los Angeles, California, 90073, United States

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Los Angeles, California, 90095, United States

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San Diego, California, 92103-8320, United States

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Torrance, California, 90502, United States

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Denver, Colorado, 80220, United States

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Denver, Colorado, 80262, United States

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Chicago, Illinois, 60637, United States

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Baltimore, Maryland, 21287, United States

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Boston, Massachusetts, 02111, United States

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Ann Arbor, Michigan, 48109, United States

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Rochester, Minnesota, 55905, United States

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New York, New York, 10032, United States

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Durham, North Carolina, 27710, United States

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Nashville, Tennessee, 37232-5735, United States

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Nashville, Tennessee, 37232, United States

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Houston, Texas, 77030, United States

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Milwaukee, Wisconsin, 53215, United States

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Darlinghurst, New South Wales, 2010, Australia

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Melbourne, Victoria, 3004, Australia

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Brussels, 1070, Belgium

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Leuven, 3000, Belgium

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São Paulo, São Paulo, 05403-900, Brazil

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Prague, 140 00, Czechia

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Prague, 140 21, Czechia

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Copenhagen, 2100, Denmark

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Clamart, 92141, France

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Giessen, 35392, Germany

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Hanover, 30625, Germany

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Leipzig, 04103, Germany

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Shatin NT, Hong Kong

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Budapest, 1529, Hungary

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Zalaegerszeg, 8900, Hungary

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Petah Tikva, 49100, Israel

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Tel Litwinsky, 52621, Israel

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Bologna, 40138, Italy

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Pisa, 56124, Italy

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Pisa, 56126, Italy

Location

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Kuala Lumpur, 59100, Malaysia

Location

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Petaling Jaya, 46200, Malaysia

Location

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Tlalpan Mexico, Mexico City, 14050, Mexico

Location

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Tlalpan, Mexico DF, 14080, Mexico

Location

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Amsterdam, 1081 HV, Netherlands

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Warsaw, 01-138, Poland

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Zabrze, 41-800, Poland

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Singapore, 168752, Singapore

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Parow, Western Cape, 7505, South Africa

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Parktown, 2193, South Africa

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Parktown West, 2193, South Africa

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Suwon, 443-721, South Korea

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Barcelona, 08035, Spain

Location

Pfizer Investigational Site

Barcelona, 08036, Spain

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Madrid, 28041, Spain

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Gothenburg, 41345, Sweden

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Papworth Everard, Cambridgeshire, CB3 8RE, United Kingdom

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Sheffield, South Yorkshire, S10 2JF, United Kingdom

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Pfizer Investigational Site

Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom

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Pfizer Investigational Site

Cambridge, CB4 9EL, United Kingdom

Location

Pfizer Investigational Site

Glasgow, G11 6NT, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 22354598 DERIVED

• 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.

  PMID: 21546436 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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: December 1, 2002
• Study Completion: February 1, 2007
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

ME (2); IT (3); FR (1); KR (1); BE (2); HK (1); SG (1); CZ (2); AU (2); HU (2); DK (1); DE (3); NL (1); GB (5); ES (3); IL (2); ZA (3); US (24); BR (1); SE (1); MY (2); PL (2)