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)
Collecte de données
Hypertension artérielle pulmonaire+5
+ Maladies Cardiovasculaires
+ Hypertension pulmonaire
Étude thérapeutique
Résumé
Date de début de l'étude : 1 mai 2003
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.240 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 12 à 75 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Centres d'étude
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