A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension

NCT ID: NCT00811018

Last Updated: 2012-04-24

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2011-07-31

Brief Summary

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This is a multi-center, open-label study of sitaxsentan sodium 100 mg taken orally once daily by subjects with PAH until sitaxsentan, in a particular country or region, is commercially available for the treatment of PAH or the study is closed.

Detailed Description

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Open-label extension

Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Sitaxsentan

Sitaxsentan

Group Type EXPERIMENTAL

Sitaxsentan

Intervention Type DRUG

Sitaxsentan 100 mg tablets once daily

Interventions

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Sitaxsentan

Sitaxsentan 100 mg tablets once daily

Intervention Type DRUG

Other Intervention Names

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Sitaxentan

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Pulmonary Arterial Hypertension (PAH) confirmed by cardiac catheterization.
* Current diagnosis of WHO group 1 PAH with functional class 2, 3, or 4 symptoms.

Exclusion Criteria

* Has portal hypertension or chronic liver disease.
* Has history of left sided heart disease or significant cardiac disease.
Minimum Eligible Age

12 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

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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Phoenix, Arizona, United States

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Los Angeles, California, United States

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San Francisco, California, United States

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Torrence, California, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Sarasota, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Decatur, Georgia, United States

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Decatur, Georgia, United States

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Chicago, Illinois, United States

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Kansas City, Kansas, United States

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Lexington, Kentucky, United States

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New Orleans, Louisiana, United States

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New Orleans, Louisiana, United States

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Portland, Maine, 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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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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Detroit, Michigan, United States

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Rochester, Minnesota, United States

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New Brunswick, New Jersey, 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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Cleveland, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Galveston, Texas, United States

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Houston, Texas, United States

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San Antonio, 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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Capital Federal, Buenos Aires, Argentina

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Capital Federal, , Argentina

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Darlinghurst, New South Wales, Australia

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Chermside Q, Queensland, Australia

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Melbourne, Victoria, Australia

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Chermside, , Australia

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Graz, , Austria

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Vienna, , Austria

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Brussels, , Belgium

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Leuven, , Belgium

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Belo Horizonte, Minas Gerais, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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São Paulo, , Brazil

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Clamart, , France

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Grenoble, , France

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Strasbourg, , France

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Berlin, , Germany

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Dresden, , Germany

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Giessen, , Germany

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Greifswald, , Germany

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Hanover, , Germany

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Heidelberg, , Germany

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Leipzig, , Germany

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Regensburg, , Germany

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Petah Tikva, , Israel

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Tel-Hashomer, Ramat Gan, , Israel

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Bologna, , Italy

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Monterrey, CP, Mexico

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Tlalpan, Mexico City, Mexico

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Monterrey, N.l., Mexico

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Amsterdam, , Netherlands

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Krakow, , Poland

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Warsaw, , Poland

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Zabrze, , Poland

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Barcelona, Barcelona, Spain

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Papworth Everard, Cambridgeshire, United Kingdom

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Glasgow, , United Kingdom

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London, , United Kingdom

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Newcastle, , United Kingdom

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Countries

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United States Argentina Australia Austria Belgium Brazil Canada France Germany Israel Italy Mexico Netherlands Poland Spain United Kingdom

Related Links

Other Identifiers

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FPH03

Identifier Type: -

Identifier Source: secondary_id

B1321007

Identifier Type: -

Identifier Source: org_study_id

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