Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients

Phase 3

Terminated

• Conditions: Hypertension, Pulmonary
• Interventions: Drug: Sitaxentan

• Registration Number: NCT01210443
• Lead Sponsor: Pfizer

Brief Summary

The safety and efficacy at 100 mg once daily for oral dose of sitaxentan sodium were demonstrated in the STRIDE clinical trial program. Sitaxentan sodium was approved in the EU, Canada and Australia. In this study, the long-term safety and efficacy after administrations of sitaxentan sodium at a dose of 100 mg alone or in combination with another medication will be investigated in Japanese PAH patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-11
• Study First Submitted QC: 2010-09-27
• Study First Posted: 2010-09-28
• Study Start: 2010-11
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-06
• Results First Submitted: 2011-11-10
• Results First Submitted QC: 2011-11-10
• Last Update Submitted: 2011-11-10
• Results First Posted: 2011-12-14
• Last Update Posted: 2011-12-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Subject who completed the B1321052 study as planned.

Exclusion Criteria

• Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure >160 mm Hg or sitting diastolic blood pressure >100 mm Hg at Screening.
• Has hypotension defined as systolic arterial pressure <90 mm Hg after sitting for 5 minutes at Screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sitaxentan treatment	Sitaxentan	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	Up to 22 days (last participant discontinuation)	Number of participants with any adverse events, severe adverse events, serious adverse events

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Clinical Worsening	Up to 22 days (last participant discontinuation)	Clinical worsening is defined as 1) Hospitalization for worsening pulmonary arterial hypertension, 2) On-study death, 3) Heart-lung or lung transplantation, 4) Atrial septostomy, 5) Addition of the chronic medications for the treatment of worsening pulmonary arterial hypertension, and 6) Initiation of oxygen.
Change From Baseline in 6-Minute Walk Distance	Up to 22 days (last participant discontinuation)	Change from baseline in 6-minute walk distance is calculated as the value at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48) minus value at baseline.
Percentage of Participants With Change From Baseline in WHO Functional Class	Up to 22 days (last participant discontinuation)	The change from baseline in WHO functional class was classified into "Improved", "No change" and "Worsened". The change from baseline in WHO functional class is summarised with percentage of participants at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48).
Change From Baseline in Blood Concentration of N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP)	Up to 22 days (last participant discontinuation)	Change from baseline in Blood Concentration of NT-pro BNP is calculated as the value at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48) minus value at baseline.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Shinjyuku-ku, Tokyo, Japan