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

Pulmonary Hypertension Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00080457
• Other study ID #: STRIDE 2
• Status: Completed
• Phase: Phase 3
• First received: April 1, 2004
• Last updated: November 8, 2007
• Start date: May 2003
• Est. completion date: January 2005

Study information

• Verified date: November 2007
• Source: Encysive Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Drug:
• sitaxsentan sodium

Locations

Country	Name	City	State
United States	Encysive Pharmaceuticals	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Encysive Pharmaceuticals

Country where clinical trial is conducted

United States,