Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2002 by ICOS-Texas Biotechnology. Recruitment status was Active, not recruiting

First Received on April 24, 2002. Last Updated on June 23, 2005 History of Changes

Sponsor:	ICOS-Texas Biotechnology
Collaborators:	ICOS Corporation Texas Biotechnology Corporation
Information provided by:	ICOS-Texas Biotechnology
ClinicalTrials.gov Identifier:	NCT00034307

Purpose

This is a clinical research study designed to evaluate an investigational new medication called sitaxsentan for the treatment of pulmonary arterial hypertension (patients with NYHA functional class II, III or IV). The purpose of this study is to evaluate the safety and effectiveness of two different doses of sitaxsentan, compared to placebo (inactive treatment) for the treatment of pulmonary arterial hypertension. Patients who complete this trial may be eligible to take part in an extension trial (Protocol FPH01-X). Eligible patients who receive placebo in the 12-week study cross over to receive sitaxsentan for the extension trial.

Condition	Intervention	Phase
Pulmonary Hypertension	Drug: sitaxsentan sodium	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension

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: Sitaxentan Sitaxsentan sodium

U.S. FDA Resources

Further study details as provided by ICOS-Texas Biotechnology:

Estimated Enrollment:

180

Eligibility

Ages Eligible for Study:	16 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

NYHA Class II, III or IV
16 to 75 years of age
Specific peak VO2 range
PPH, PAH due to connective tissue disease or select congenital heart disease
Qualifying cardiac catheterization
History of CXR and qualifying pulmonary function test
History of qualifying ventilation-perfusion lung scan
History of qualifying echocardiogram
Women of childbearing potential must use contraceptives
Stable dose of corticosteroids if prescribed

Exclusion Criteria:

Significant lung disease
Chronic liver disease
Uncontrolled sleep apnea
History of specific types of left heart disease
Any disorder that compromises ability to give informed consent
Uncontrolled sleep apnea
Inability to perform bicycle exercise test
On-going treatment with an experimental drug or device within the last 30 days
HIV infection
Specific liver dysfunction
Chronic renal disease
Pregnancy/Nursing
Chronic active hepatitis B or C
Chronic Flolan or Tracleer use within the last 30 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00034307

Show 26 Study Locations

Sponsors and Collaborators

ICOS-Texas Biotechnology

ICOS Corporation

Texas Biotechnology Corporation

Investigators

Study Director:

Lyn Frumkin, M.D., Ph.D.

ICOS Corporation

More Information

Additional Information:

Pulmonary Hypertension Association This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00034307 History of Changes
Other Study ID Numbers:	FPH01/FPH01-X
Study First Received:	April 24, 2002
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hypertension, Pulmonary
Hypertension
Lung Diseases

Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012