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)
Data Collection
Pulmonary Arterial Hypertension+5
+ Cardiovascular Diseases
+ Hypertension
Treatment Study
Summary
Study start date: May 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.240 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 12 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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: 1. mean pulmonary artery pressure (PAPm) greater than 25 mmHg (at rest), 2. pulmonary capillary wedge pressure (PCWP) or left ventricular-end diastolic pressure less than 15 mmHg, and 3. 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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location