Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial Hypertension

This study has been completed.

Sponsor:

Information provided by:

Encysive Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00080457

First received: April 1, 2004

Last updated: November 8, 2007

Last verified: November 2007

History of Changes

Tracking Information
First Received Date ^ICMJE	April 1, 2004
Last Updated Date	November 8, 2007
Start Date ^ICMJE	May 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00080457 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial Hypertension
Official Title ^ICMJE	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium (Thelin™) Treatment With an Open-Label Bosentan Arm in Patients With Pulmonary Arterial Hypertension (PAH)
Brief Summary	The purpose of this study is to evaluate the safety and efficacy of Thelin™ (sitaxsentan sodium) compared to placebo (sugar pill) in the treatment of patients with pulmonary arterial hypertension (PAH).
Detailed Description	The purpose of this study is to evaluate the safety and efficacy of Thelin™ (sitaxsentan sodium) as compared to placebo in the treatment of patients with PAH. A cohort of patients will be randomized to usual treatment with Tracleer® (bosentan) for observational comparisons of safety and efficacy.
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Pulmonary Hypertension
Intervention ^ICMJE	Drug: sitaxsentan sodium
Study Arm (s)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	240
Completion Date	January 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Have a current diagnosis of symptomatic PAH classified by one of the following: primary pulmonary hypertension (PPH) - also known as idiopathic pulmonary arterial hypertension (IPAH); PAH associated with connective tissue diseases; PAH associated with one of the following congenital heart defects: repaired ASD, VSD or PDA greater than one year post-operative un-repaired secundum ASD (with resting oxygen saturation greater than 88 percent in room air measured by oximeter) World Health Organization (WHO) functional class II, III, IV Greater than 12 and less than 75 years of age Women of childbearing potential must be using two forms of medically acceptable contraception (at least one barrier method) Have a cardiac catheterization within 6 months before study entry that shows the following values: mean pulmonary artery pressure (PAPm) greater than 25 mmHg (at rest), pulmonary capillary wedge pressure (PCWP) or left ventricular-end diastolic pressure less than 15 mmHg, and pulmonary vascular resistance (PVR) greater than 3 mmHg/L/min. Exclusion Criteria: Portal hypertension or chronic liver disease ALT or AST levels greater than 1.5 times the upper limit of normal at the Screening Visit Contraindication to treatment with an endothelin receptor antagonist Recent history of abusing alcohol or illicit drugs Chronic renal insufficiency Pregnant or breastfeeding Atrial septostomy within 30 days before study entry Previous failure on bosentan because of safety concerns of the lack of clinical response
Gender	Both
Ages	12 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00080457
Other Study ID Numbers ^ICMJE	STRIDE 2
Has Data Monitoring Committee
Responsible Party
Study Sponsor ^ICMJE	Encysive Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Encysive Pharmaceuticals
Verification Date	November 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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