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

Last updated on November 17, 2019

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


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 18, 2011)
183
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2008)
180
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion DateMarch 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 16 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE 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
Removed Location CountriesEgypt,   Jordan,   Lebanon,   United Arab Emirates
 
Administrative Information
NCT Number  ICMJE NCT00795639
Other Study ID Numbers  ICMJE B1321001
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2015

ICMJE     Data element required by the

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

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