Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-28 @ 5:52 AM
Study NCT ID:
NCT00080457
Status:
COMPLETED
Last Update Posted:
2007-11-09
First Post:
2004-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D045743', 'term': 'Scleroderma, Diffuse'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-05'}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-08', 'studyFirstSubmitDate': '2004-04-01', 'studyFirstSubmitQcDate': '2004-04-02', 'lastUpdatePostDateStruct': {'date': '2007-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-04-05', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Primary or secondary pulmonary arterial hypertension', 'Scleroderma', 'Connective tissue disease', 'Congenital heart defects', 'Lupus', 'Pulmonary Arterial Hypertension'], 'conditions': ['Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a current diagnosis of symptomatic PAH classified by one of the following:\n\n 1. primary pulmonary hypertension (PPH) - also known as idiopathic pulmonary arterial hypertension (IPAH);\n 2. PAH associated with connective tissue diseases;\n 3. PAH associated with one of the following congenital heart defects:\n\n 1. repaired ASD, VSD or PDA greater than one year post-operative\n 2. un-repaired secundum ASD (with resting oxygen saturation greater than 88 percent in room air measured by oximeter)\n* World Health Organization (WHO) functional class II, III, IV\n* Greater than 12 and less than 75 years of age\n* Women of childbearing potential must be using two forms of medically acceptable contraception (at least one barrier method)\n* Have a cardiac catheterization within 6 months before study entry that shows the following values:\n\n 1. mean pulmonary artery pressure (PAPm) greater than 25 mmHg (at rest),\n 2. pulmonary capillary wedge pressure (PCWP) or left ventricular-end diastolic pressure less than 15 mmHg, and\n 3. pulmonary vascular resistance (PVR) greater than 3 mmHg/L/min.\n\nExclusion Criteria:\n\n* Portal hypertension or chronic liver disease\n* ALT or AST levels greater than 1.5 times the upper limit of normal at the Screening Visit\n* Contraindication to treatment with an endothelin receptor antagonist\n* Recent history of abusing alcohol or illicit drugs\n* Chronic renal insufficiency\n* Pregnant or breastfeeding\n* Atrial septostomy within 30 days before study entry\n* Previous failure on bosentan because of safety concerns of the lack of clinical response'}, 'identificationModule': {'nctId': 'NCT00080457', 'briefTitle': 'Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Encysive Pharmaceuticals'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'STRIDE 2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'sitaxsentan sodium', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '77401', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Encysive Pharmaceuticals', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Encysive Pharmaceuticals', 'class': 'INDUSTRY'}}}}