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

• ClinicalTrials.gov Identifier: NCT01210443
• Recruitment Status: Terminated
• First Posted: September 28, 2010
• Results First Posted: December 14, 2011
• Last Update Posted: December 14, 2011
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypertension, Pulmonary	Drug: Sitaxentan	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Sitaxentan Sodium In Japanese Subjects With Pulmonary Arterial Hypertension
• Study Start Date: November 2010
• Actual Primary Completion Date: December 2010
• Actual Study Completion Date: December 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Sitaxentan treatment	Drug: Sitaxentan; sitaxentan sodium 100 mg

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Adverse Events [ Time Frame: Up to 22 days (last participant discontinuation) ]
   Number of participants with any adverse events, severe adverse events, serious adverse events

Secondary Outcome Measures :

1. Percentage of Participants With Clinical Worsening [ Time Frame: 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.
2. Change From Baseline in 6-Minute Walk Distance [ Time Frame: 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.
3. Percentage of Participants With Change From Baseline in WHO Functional Class [ Time Frame: 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).
4. Change From Baseline in Blood Concentration of N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP) [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 80 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Japan

Pfizer Investigational Site

Nagoya, Aichi, Japan

Pfizer Investigational Site

Shinjyuku-ku, Tokyo, Japan

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01210443
• Other Study ID Numbers: B1321053
• First Posted: September 28, 2010
• Results First Posted: December 14, 2011
• Last Update Posted: December 14, 2011
• Last Verified: June 2011

Keywords provided by Pfizer:

sitaxentan sodium pulmonary hypertension

Additional relevant MeSH terms:

Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Hypertension; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Sitaxsentan; Endothelin Receptor Antagonists; Molecular Mechanisms of Pharmacological Action