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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Fountain Valley, California, 92708 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Arterial Hypertension, Pulmonary Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Current diagnosis of symptomatic pulmonary arterial hypertension (PAH) classified by
one of the following: idiopathic arterial hypertension (IPAH), primary pulmonary
hypertension (PPH), familial pulmonary arterial hypertension (FPAH) or pulmonary
arterial hypertension (PAH) associated with connective tissue diseases. Has WHO
functional class III symptoms.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Previous exposure to an endothelin receptor antagonist (ETRA) such as sitaxsentan,
bosentan or ambrisentan.

NCT00795639
Pfizer
Terminated
Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS)

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Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS)
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Safety And Efficacy Study Of Sitaxsentan Sodium In Subjects With Pulmonary Arterial Hypertension
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Pulmonary Arterial Hypertension
  • Pulmonary Hypertension
  • Drug: Sitaxsentan
    Sitaxsentan = 100 mg tablet administered orally, once daily
  • Drug: Placebo
    Sitaxsentan Placebo = 1 tablet administered orally, once daily
    Other Name: Sitaxsentan Placebo
  • Experimental: Sitaxsentan
    Monotherapy
    Intervention: Drug: Sitaxsentan
  • Placebo Comparator: Sitaxsentan Placebo
    Monotherapy
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
183
March 2011
March 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Current diagnosis of symptomatic pulmonary arterial hypertension (PAH) classified by one of the following: idiopathic arterial hypertension (IPAH), primary pulmonary hypertension (PPH), familial pulmonary arterial hypertension (FPAH) or pulmonary arterial hypertension (PAH) associated with connective tissue diseases. Has WHO functional class III symptoms.

Exclusion Criteria:

  • Previous exposure to an endothelin receptor antagonist (ETRA) such as sitaxsentan, bosentan or ambrisentan.
Sexes Eligible for Study: All
16 Years to 80 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Bulgaria,   Chile,   China,   Colombia,   Costa Rica,   Czech Republic,   Dominican Republic,   Guatemala,   India,   Malaysia,   Mexico,   Peru,   Philippines,   Romania,   Russian Federation,   Saudi Arabia,   Serbia,   Slovakia,   South Africa,   Thailand,   Turkey,   Ukraine,   United States
Egypt,   Jordan,   Lebanon,   United Arab Emirates
 
NCT00795639
B1321001
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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