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

Phase 3

Terminated

• Conditions: Pulmonary Hypertension; Pulmonary Arterial Hypertension
• Interventions: Drug: Sitaxsentan; Drug: Sitaxsentan and Sildenafil

• Registration Number: NCT00796510
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-20
• Study First Submitted QC: 2008-11-20
• Study First Posted: 2008-11-24
• Study Start: 2010-07
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2011-12-09
• Results First Submitted QC: 2012-01-20
• Results First Posted: 2012-02-20
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-26
• Last Update Posted: 2018-10-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sitaxsentan	Sitaxsentan	Monotherapy arm
Sitaxsentan and Sildenafil	Sitaxsentan and Sildenafil	Combination treatment

Primary Outcome Measures

Name	Time	Method
Overall Survival	Baseline and every 12 weeks up to Week 18	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in 6 Minute Walk Distance at Weeks 12 and 24	Baseline, Weeks 12 up to Early Termination (ET) (up to Week 18)	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.
Number of Participants in Each World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension (PAH)	Baseline, Week 12 and ET (up to Week 18)	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).

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇦 Kyiv, Ukraine