MedTrace Logo

Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS)

NCT00795639 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2015-03-24

Study results available
· View outcomes & findings →

Summary

This protocol is for subjects with pulmonary arterial hypertension and is the first of 3 studies forming the Sitaxsentan efficacy and safety trial with Randomized Prospective Assessment of Adding Sildenafil (SR-PAAS) program.

Conditions

Interventions

DRUG

Sitaxsentan

Sitaxsentan = 100 mg tablet administered orally, once daily

DRUG

Placebo

Sitaxsentan Placebo = 1 tablet administered orally, once daily

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States
  • Argentina
  • Bulgaria
  • Chile
  • China
  • Colombia
  • Costa Rica
  • Czechia
  • Dominican Republic
  • Guatemala
  • India
  • Malaysia
  • Mexico
  • Peru
  • Philippines
  • Romania
  • Russia
  • Saudi Arabia
  • Serbia
  • Slovakia
  • South Africa
  • Thailand
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
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 NCT00795639 on ClinicalTrials.gov