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

Hypertension, Pulmonary Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01210443
• Other study ID #: B1321053
• Status: Terminated
• Phase: Phase 3
• First received: August 11, 2010
• Last updated: November 10, 2011
• Start date: November 2010
• Est. completion date: December 2010

Study information

• Verified date: June 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary

Intervention

Drug:
• Sitaxentan
sitaxentan sodium 100 mg

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Nagoya	Aichi
Japan	Pfizer Investigational Site	Shinjyuku-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events	Number of participants with any adverse events, severe adverse events, serious adverse events	Up to 22 days (last participant discontinuation)	Yes
Secondary	Percentage of Participants With Clinical Worsening	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.	Up to 22 days (last participant discontinuation)	Yes
Secondary	Change From Baseline in 6-Minute Walk Distance	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.	Up to 22 days (last participant discontinuation)	No
Secondary	Percentage of Participants With Change From Baseline in WHO Functional Class	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).	Up to 22 days (last participant discontinuation)	No
Secondary	Change From Baseline in Blood Concentration of N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP)	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.	Up to 22 days (last participant discontinuation)	No

External Links

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