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Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension

NCT00034307 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2005-06-24

No results posted yet for this study

Summary

This is a clinical research study designed to evaluate an investigational new medication called sitaxsentan for the treatment of pulmonary arterial hypertension (patients with NYHA functional class II, III or IV). The purpose of this study is to evaluate the safety and effectiveness of two different doses of sitaxsentan, compared to placebo (inactive treatment) for the treatment of pulmonary arterial hypertension. Patients who complete this trial may be eligible to take part in an extension trial (Protocol FPH01-X). Eligible patients who receive placebo in the 12-week study cross over to receive sitaxsentan for the extension trial.

Conditions

  • Pulmonary Hypertension

Interventions

DRUG

sitaxsentan sodium

Sponsors & Collaborators

  • ICOS Corporation

    collaborator INDUSTRY

  • Texas Biotechnology Corporation

    collaborator INDUSTRY

  • ICOS-Texas Biotechnology

    lead INDUSTRY

Principal Investigators

  • Lyn Frumkin, M.D., Ph.D. · ICOS Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00034307 on ClinicalTrials.gov