Open-Label Study Providing Monotherapy (Sitaxsentan) and Combination Therapy (Sitaxsentan+Sildenafil) to Subjects With PAH to Assess Long-Term Safety This is One of Three Protocols in the SR-PAAS Program - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00796510

Purpose

As sitaxsentan is the agent most highly selective for ETA (Endothelin Type A (receptor)), and does not significantly impact sildenafil pharmacokinetics the combination of most promise for PAH therapy is these two oral drugs administered in combination.

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

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: Dietary Sodium High Blood Pressure Pulmonary Hypertension

Drug Information available for: Sildenafil citrate Sildenafil Citric acid Sodium Citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety Study
Official Title:	A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Monotherapy Sitaxsentan Sodium And Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension.

Further study details as provided by Pfizer:

Primary Outcome Measures:

The primary objective is to evaluate the long-term safety in subjects with PAH who are eligible for this study if B1321003 was completed, if early escape was met in B1321001, or early discontinuation in B1321003. [ Time Frame: Throughout ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The secondary objective is to evaluate the efficacy in subjects with PAH who are eligible for this study if B1321003 was completed, if early escape was met in B1321001, or early discontinuation in B1321003 by determining change in 6MWD. [ Time Frame: Baseline/Day 1 to Weeks 12 and 24 ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	March 2009
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sitaxsentan: Experimental Monotherapy arm	Drug: Sitaxsentan Sitaxsentan = 100 mg tablet administered orally, once daily
Sitaxsentan and Sildenafil: Experimental Combination treatment	Drug: Sitaxsentan and Sildenafil Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day

Eligibility

Ages Eligible for Study:	16 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Previously enrolled in B1321001 for at least 4 weeks
Previously enrolled in B1321003, discontinued from the study.
Completed the B1321003 study as planned

Exclusion Criteria:

Treated with an investigational drug (other than sitaxsentan or sildenafil in either B1321001 or B1321003) or device that has not received regulatory approval within the 30 days prior to Baseline/Day 1 or during the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796510

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45219
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78229

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:	B1321002, B1321002
Study First Received:	November 20, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00796510
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

ETRA sitaxsentan

Study placed in the following topic categories:

Idiopathic pulmonary hypertension
Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases

Citric Acid
Vascular Diseases
Sildenafil
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Enzyme Inhibitors
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009