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

NCT ID: NCT00795639

Last Updated: 2015-03-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Arterial Hypertension Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sitaxsentan

Monotherapy

Group Type EXPERIMENTAL

Sitaxsentan

Intervention Type DRUG

Sitaxsentan = 100 mg tablet administered orally, once daily

Sitaxsentan Placebo

Monotherapy

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Sitaxsentan Placebo = 1 tablet administered orally, once daily

Interventions

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Sitaxsentan

Sitaxsentan = 100 mg tablet administered orally, once daily

Intervention Type DRUG

Placebo

Sitaxsentan Placebo = 1 tablet administered orally, once daily

Intervention Type DRUG

Other Intervention Names

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Sitaxsentan Placebo

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Fountain Valley, California, United States

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Mather, California, United States

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Sacramento, California, United States

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Englewood, Colorado, United States

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Littleton, Colorado, United States

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Gainesville, Florida, United States

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Sarasota, Florida, United States

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Weston, Florida, United States

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Chicago, Illinois, United States

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Olathe, Kansas, United States

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Towson, Maryland, United States

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Boston, Massachusetts, United States

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Omaha, Nebraska, United States

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New Brunswick, New Jersey, United States

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Islandia, New York, United States

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Stony Brook, New York, United States

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Chapel Hill, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Lancaster, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Temple, Texas, United States

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Lynchburg, Virginia, United States

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Richmond, Virginia, United States

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Milwaukee, Wisconsin, United States

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Veliko Tarnovo, , Bulgaria

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Temuco, , Chile

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Changsha, Hunan, China

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Xi’an, Shanxi, China

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Beijing, , China

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Shanghai, , China

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Shanghai, , China

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Bogotá, Cundinamarca, Colombia

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Escazú, Provincia de San José, Costa Rica

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Prague, , Czechia

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Santo Domingo, República Dominicana, Dominican Republic

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Santo Domingo, Santo Domingo Province, Dominican Republic

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Guatemala City, Departamento de Guatemala, Guatemala

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Hyderabad, Andhera Pradesh, India

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Hyderabad, Andhra Pradesh, India

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Ahmedabad, Gujarat, India

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Surat, Gujarat, India

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Vadodara, Gujarat, India

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Pune, Maharashtra, India

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Coimbatore, Tamil Nadu, India

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Madurai, Tamil Nadu, India

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George Town, Pulau Pinang, Malaysia

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Mexico City, Mexico City, Mexico

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Mexico City, Mexico City, Mexico

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Monterrey, Nuevo León, Mexico

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Lima, , Peru

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Lima, , Peru

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Quezon City, , Philippines

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Cluj-Napoca, Romania, Romania

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Iași, , Romania

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Moscow, , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Riyadh, , Saudi Arabia

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Belgrade, , Serbia

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Bratislava, , Slovakia

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Cape Town, Western Cape, South Africa

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Cape Town, , South Africa

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Johannesburg, , South Africa

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Stellenbosch, , South Africa

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Bangkoknoi, Bangkok, Thailand

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Bangkok, , Thailand

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Istanbul, Fatih, , Turkey (Türkiye)

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Countries

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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

Related Links

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Other Identifiers

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B1321001

Identifier Type: -

Identifier Source: org_study_id

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