MedTrace Logo

A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension

NCT00811018 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1192

Last updated 2012-04-24

Study results available
· View outcomes & findings →

Summary

This is a multi-center, open-label study of sitaxsentan sodium 100 mg taken orally once daily by subjects with PAH until sitaxsentan, in a particular country or region, is commercially available for the treatment of PAH or the study is closed.

Conditions

Interventions

DRUG

Sitaxsentan

Sitaxsentan 100 mg tablets once daily

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • France
  • Germany
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00811018 on ClinicalTrials.gov