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Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil

NCT00796666 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2015-03-24

Study results available
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Summary

As monotherapy for pulmonary arterial hypertension (PAH) begins to fail additional therapies are introduced. Although co-administration of sitaxsentan and sildenafil is well tolerated the controlled safety/efficacy database of the combination is limited.

Conditions

Interventions

DRUG

Sitaxsentan

Sitaxsentan = 100 mg tablet administered orally, once daily Sildenafil placebo = 1 tablet administered orally, three times a day

DRUG

Sitaxsentan and Sildenafil

Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day

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
2009-05-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States
  • Argentina
  • Bulgaria
  • Chile
  • China
  • Colombia
  • Czechia
  • India
  • Malaysia
  • Mexico
  • Peru
  • Romania
  • Russia
  • Serbia
  • South Africa
  • Thailand
  • Turkey (Türkiye)
  • Ukraine

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 NCT00796666 on ClinicalTrials.gov