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
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, see Learn About Clinical Studies.

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 August 20, 2014