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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00811018

Purpose

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.

Condition	Intervention	Phase
PAH Pulmonary Arterial Hypertension	Drug: Sitaxsentan	Phase III

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: Dietary Sodium High Blood Pressure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension

Further study details as provided by Pfizer:

Primary Outcome Measures:

The primary objective of this study is to evaluate the long-term safety of sitaxsentan sodium 100 mg taken orally once daily by subjects with PAH. [ Time Frame: At study completion ] [ Designated as safety issue: No ]

Enrollment:	1208
Study Start Date:	March 2003
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sitaxsentan: Experimental Sitaxsentan	Drug: Sitaxsentan Sitaxsentan 100 mg tablets once daily

Detailed Description:

Open-label extension

Eligibility

Ages Eligible for Study:	12 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811018

Show 53 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	B1321007, FPH03
Study First Received:	December 9, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00811018
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Open-label study

Study placed in the following topic categories:

Idiopathic pulmonary hypertension
Respiratory Tract Diseases
Hypertension, Pulmonary

Lung Diseases
Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009