Not Signed In -
Pulmonary Hypertension |
Ayerza Syndrome; familial primary pulmonary hypertension (FPPH); Hypertension, Pulmonary; Idiopathic pulmonary hypertension; PPH; Primary Pulmonary Hypertension; pulmonary arterial hypertension; sporadic primary pulmonary hypertension |
Clinical Trial: Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients with Pulmonary Arterial Hypertension
This study is no longer recruiting patients.
|
Purpose
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).
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Pulmonary Hypertension | Drug: sitaxsentan sodium | Phase III |
MedlinePlus related topics: Pulmonary Hypertension
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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)
Expected Total Enrollment: 240
Study start: May 2003
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
Ages Eligible for Study: 12 Years - 75 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Have a current diagnosis of symptomatic PAH classified by one of the following: (a) primary pulmonary hypertension (PPH) - also known as idiopathic pulmonary arterial hypertension (IPAH); (b) PAH associated with connective tissue diseases; (c) 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
Location Information
Texas
Encysive Pharmaceuticals, Houston, Texas, 77401, United States
More Information
Record last reviewed: September 2004
Last Updated: October 13, 2004
Record first received: April 1, 2004
ClinicalTrials.gov Identifier: NCT00080457
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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