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

This study has been terminated.
(Safety Issue: The trial was prematurely terminated on Dec 9, 2010, due to safety concerns, specifically new emerging evidence of hepatic injury.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01210443
First received: August 11, 2010
Last updated: November 10, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention Phase
Hypertension, Pulmonary
 Drug: Sitaxentan
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: Up to 22 days (last participant discontinuation) ] [ Designated as safety issue: Yes ]
    Number of participants with any adverse events, severe adverse events, serious adverse events


Secondary Outcome Measures:
  • Percentage of Participants With Clinical Worsening [ Time Frame: Up to 22 days (last participant discontinuation) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to 22 days (last participant discontinuation) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 22 days (last participant discontinuation) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Up to 22 days (last participant discontinuation) ] [ Designated as safety issue: No ]
    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.


Enrollment: 2
Study Start Date: November 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitaxentan treatment Drug: Sitaxentan
sitaxentan sodium 100 mg

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01210443

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.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01210443     History of Changes
Other Study ID Numbers: B1321053
Study First Received: August 11, 2010
Results First Received: November 10, 2011
Last Updated: November 10, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:
sitaxentan sodium pulmonary hypertension

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
 Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013