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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00080457
Recruitment Status : Completed
First Posted : April 5, 2004
Last Update Posted : November 9, 2007
Information provided by:
Encysive Pharmaceuticals

Brief 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).

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Drug: sitaxsentan sodium Phase 3

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  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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)
Study Start Date : May 2003
Study Completion Date : January 2005

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00080457

United States, Texas
Encysive Pharmaceuticals
Houston, Texas, United States, 77401
Sponsors and Collaborators
Encysive Pharmaceuticals

Additional Information: Identifier: NCT00080457     History of Changes
Other Study ID Numbers: STRIDE 2
First Posted: April 5, 2004    Key Record Dates
Last Update Posted: November 9, 2007
Last Verified: November 2007

Keywords provided by Encysive Pharmaceuticals:
Primary or secondary pulmonary arterial hypertension
Connective tissue disease
Congenital heart defects
Pulmonary Arterial Hypertension

Additional relevant MeSH terms:
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action