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

November 8, 2007 updated by: Encysive Pharmaceuticals

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77401
        • Encysive Pharmaceuticals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Encysive Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

April 1, 2004

First Submitted That Met QC Criteria

April 2, 2004

First Posted (Estimate)

April 5, 2004

Study Record Updates

Last Update Posted (Estimate)

November 9, 2007

Last Update Submitted That Met QC Criteria

November 8, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STRIDE 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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