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

This study has been completed.
Sponsor:
Information provided by:
Encysive Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00080457
First received: April 1, 2004
Last updated: November 8, 2007
Last verified: November 2007
  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 Intervention Phase
Pulmonary Hypertension
Drug: sitaxsentan sodium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


Further study details as provided by Encysive Pharmaceuticals:

Estimated Enrollment: 240
Study Start Date: May 2003
Study Completion Date: January 2005
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.

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00080457

Locations
United States, Texas
Encysive Pharmaceuticals
Houston, Texas, United States, 77401
Sponsors and Collaborators
Encysive Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00080457     History of Changes
Other Study ID Numbers: STRIDE 2
Study First Received: April 1, 2004
Last Updated: November 8, 2007
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014