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Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial Hypertension | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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)

NCT00080457•Encysive Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

12 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Have a current diagnosis of symptomatic PAH classified by one of the following:
•1. primary pulmonary hypertension (PPH) - also known as idiopathic pulmonary arterial hypertension (IPAH);
•2. PAH associated with connective tissue diseases;
•3. PAH associated with one of the following congenital heart defects:
•1. repaired ASD, VSD or PDA greater than one year post-operative
•2. 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:
+3 more criteria

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

Locations (1)

Encysive Pharmaceuticals

Houston, Texas, United States

Key Dates

Start Date

May 1, 2003

Completion Date

January 1, 2005

Last Updated

November 9, 2007

Enrollment

240

Estimated participants

Conditions

Pulmonary Hypertension

Interventions

sitaxsentan sodium

DRUG

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

NCT07073820

Pulmonary Hypertension

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 9, 2007Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

Preliminary Human Trials of F230 Tablets

Sildinafil in Pulmonary Hypertension-Rheumatic Chronic Valvular Disease(RCT)

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CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH