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

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Pulmonary Hypertension; Pulmonary Arterial Hypertension

Treatments: Drug: Placebo; Drug: Sitaxsentan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00795639

B1321001

Details and patient eligibility

About

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.

Enrollment: 183 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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183 participants in 2 patient groups, including a placebo group

Sitaxsentan

Experimental group

Description:

Monotherapy

Treatment:

Drug: Sitaxsentan

Sitaxsentan Placebo

Placebo Comparator group

Description:

Monotherapy

Treatment:

Drug: Placebo