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

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Pulmonary Hypertension; Pulmonary Arterial Hypertension

Treatments: Drug: Sitaxsentan and Sildenafil; Drug: Sitaxsentan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00796666

B1321003

Details and patient eligibility

About

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.

Enrollment: 131 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previously enrolled in B1321001 (NCT00795639) and completed the 12-week study as planned.

Exclusion criteria

• Treated with an investigational drug, other than sitaxsentan sodium in B1321001 (NCT00795639), or device that has not received regulatory approval within the 30 days prior to Baseline/Day 1 or during the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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131 participants in 2 patient groups

Sitaxsentan and Placebo

Experimental group

Description:

Monotherapy arm

Treatment:

Drug: Sitaxsentan

Sitaxsentan and Sildenafil

Experimental group

Description:

Combination treatment

Treatment:

Drug: Sitaxsentan and Sildenafil