Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety

Phase 3TerminatedNCT00796510

Pfizer3 enrolled

Overview

As sitaxsentan is the agent most highly selective for ETA (Endothelin Type A (receptor)), and does not significantly impact sildenafil pharmacokinetics the combination of most promise for pulmonary arterial hypertension (PAH) therapy is these two oral drugs administered in combination.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Arterial Hypertension Pulmonary Hypertension

Interventions

SitaxsentanDRUG

Sitaxsentan = 100 mg tablet administered orally, once daily

Sitaxsentan and SildenafilDRUG

Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day

Eligibility

Sex: ALLMin age: 16 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Previously enrolled in B1321001 for at least 4 weeks. * Previously enrolled in B1321003, discontinued from the study. * Completed the B1321003 study as planned. Exclusion Criteria: * Treated with an investigational drug (other than sitaxsentan or sildenafil in either B1321001 or B1321003) or device that has not received regulatory approval within the 30 days prior to Baseline/Day 1 or during the study.

Locations (3)

Pfizer Investigational Site

Fountain Valley, California, United States

Pfizer Investigational Site

Cluj-Napoca, Romania

Pfizer Investigational Site

Kyiv, Ukraine

Outcomes

Primary Outcomes

Overall Survival

Overall survival is the duration from first dose to death. For participants who are lost to follow-up, survival was censored at the last date of follow-up.

Time frame: Baseline and every 12 weeks up to Week 18

Secondary Outcomes

Change From Baseline in 6 Minute Walk Distance at Weeks 12 and 24

The walk distance was the total distance walked during the 6-minute test. Change is distance walked at week x minus distance walked at baseline.

Time frame: Baseline, Weeks 12 up to Early Termination (ET) (up to Week 18)

Number of Participants in Each World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension (PAH)

The WHO functional classes of PAH range from Class 1 (no limitation in physical activity) to Class IV (can not perform a physical activity without any symptoms).

Time frame: Baseline, Week 12 and ET (up to Week 18)

Data from ClinicalTrials.gov

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