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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00080457
• Date of registration: 01/04/2004
• Prospective Registration: No
• Primary sponsor: Encysive Pharmaceuticals
• Public title: Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial Hypertension
• Scientific 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)
• Date of first enrolment: May 2003
• Target sample size: 240
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00080457
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

United States

Key inclusion & exclusion 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



Age minimum: 12 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Pulmonary Hypertension

Intervention(s)

Drug: sitaxsentan sodium

Secondary ID(s)

STRIDE 2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors