Study to Assess the Longterm Safety of Sildenafil Citrate in Patients With Pulmonary Arterial Hypertension - Full Text View

Purpose

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

Condition	Intervention	Phase
Pulmonary Hypertension	Drug: Sildenafil citrate	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multi-Centre, Multinational, Long-Term Extension Study, to Assess the Safety and Toleration of Subject Optimised Treatment Regimens of Oral Sildenafil Citrate for Pulmonary Arterial Hypertension in Subjects Who Have Completed Study A1481140.

Resource links provided by NLM:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: Sodium citrate Sildenafil Sildenafil citrate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Safety
Standard safety data
Efficacy
6-Minute Walk Test
BORG Dyspnoea Score
WHO Functional Class
Quality of Life SF-36 and EQ-5D

Enrollment:	260
Study Start Date:	December 2002
Study Completion Date:	February 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159887

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Locations

United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294-0006
United States, California
Pfizer Investigational Site
La Jolla, California, United States, 92037
Pfizer Investigational Site
La Jolla, California, United States, 92093
Pfizer Investigational Site
Los Angeles, California, United States, 90095
Pfizer Investigational Site
Los Angeles, California, United States, 90024
Pfizer Investigational Site
Los Angeles, California, United States, 90033
Pfizer Investigational Site
Los Angeles, California, United States, 90073
Pfizer Investigational Site
San Diego, California, United States, 92103-8320
Pfizer Investigational Site
Torrance, California, United States, 90502
United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States, 80262
Pfizer Investigational Site
Denver, Colorado, United States, 80220
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60637
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02111
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Pfizer Investigational Site
Rochester, Minnesota, United States, 55905
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10032
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27710
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232-5735
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030
United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53215
Australia, New South Wales
Pfizer Investigational Site
Darlinghurst, New South Wales, Australia, 2010
Australia, Victoria
Pfizer Investigational Site
Melbourne, Victoria, Australia, 3004
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Pfizer Investigational Site
Leuven, Belgium, 3000
Brazil
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 05403-900
Czech Republic
Pfizer Investigational Site
Prague 4, Czech Republic, 140 00
Pfizer Investigational Site
Prague 4, Czech Republic, 140 21
Denmark
Pfizer Investigational Site
Kobenhavn, Denmark, 2100
France
Pfizer Investigational Site
Clamart Cedex, France, 92141
Germany
Pfizer Investigational Site
Giessen, Germany, 35392
Pfizer Investigational Site
Hannover, Germany, 30625
Pfizer Investigational Site
Leipzig, Germany, 04103
Hong Kong
Pfizer Investigational Site
Shatin NT, Hong Kong
Hungary
Pfizer Investigational Site
Budapest, Hungary, 1529
Pfizer Investigational Site
Zalaegerszeg, Hungary, 8900
Israel
Pfizer Investigational Site
Petach Tikva, Israel, 49100
Pfizer Investigational Site
Tel Hashomer, Israel, 52621
Italy
Pfizer Investigational Site
Bologna, Italy, 40138
Pfizer Investigational Site
Pisa, Italy, 56124
Pfizer Investigational Site
Pisa, Italy, 56126
Korea, Republic of
Pfizer Investigational Site
Suwon, Korea, Republic of, 443-721
Malaysia
Pfizer Investigational Site
Kuala Lumpur, Malaysia, 59100
Pfizer Investigational Site
Petaling Jaya, Malaysia, 46200
Mexico
Pfizer Investigational Site
Tlalpan Mexico, DF, Mexico, 14050
Pfizer Investigational Site
Tlalpan, Mexico DF, Mexico, 14080
Netherlands
Pfizer Investigational Site
Amsterdam, Netherlands, 1081 HV
Poland
Pfizer Investigational Site
Warszawa, Poland, 01-138
Pfizer Investigational Site
Zabrze, Poland, 41-800
Singapore
Pfizer Investigational Site
Singapore, Singapore, 168752
South Africa
Pfizer Investigational Site
Parow, Western Cape, South Africa, 7505
Pfizer Investigational Site
Parktown, South Africa, 2193
Pfizer Investigational Site
Parktown West, South Africa, 2193
Spain
Pfizer Investigational Site
Barcelona, Spain, 08036
Pfizer Investigational Site
Barcelona, Spain, 08035
Pfizer Investigational Site
Madrid, Spain, 28041
Sweden
Pfizer Investigational Site
Goteborg, Sweden, 41345
United Kingdom
Pfizer Investigational Site
Papworth Everard, Cambridgeshire, United Kingdom, CB3 8RE
Pfizer Investigational Site
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Pfizer Investigational Site
Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
Pfizer Investigational Site
Cambridge, United Kingdom, CB4 9EL
Pfizer Investigational Site
Glasgow, United Kingdom, G11 6NT

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rubin LJ, Badesch DB, Fleming TR, Galiè 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):1274-83. Epub 2011 May 5.

ClinicalTrials.gov Identifier:	NCT00159887 History of Changes
Other Study ID Numbers:	A1481142
Study First Received:	September 8, 2005
Last Updated:	June 7, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Citric Acid
Sildenafil
Anticoagulants
Hematologic Agents

Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Cardiovascular Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013