A 12 Week Safety And Efficacy 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:
NCT01204853
First received: August 6, 2010
Last updated: October 26, 2011
Last verified: October 2011
  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 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 Safety And Efficacy Of Sitaxentan Sodium In Japanese Subjects With Pulmonary Arterial Hypertension

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Number of participants with any adverse events, severe adverse events, serious adverse events

  • Change From Baseline in 6-minute Walk Distance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in 6-minute walk distance is calculated as the value at Week 12 minus value at baseline.


Secondary Outcome Measures:
  • Change From Baseline in WHO Functional Class [ Time Frame: 12 weeks ] [ 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 at Week 12 was to be summarized with frequency count and percentage in each category based on imputed data for missing values at Week 12.

  • Number of Participants With Haemodynamics Parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    The following haemodynamic measurements were assessed: right arterial pressure, pulmonary arterial systolic pressure, pulmonary arterial diastolic pressure, mean pulmonary arterial pressure, pulmonary capillary wedge pressure, left ventricular-end diastolic pressure, cardiac output, systemic arterial blood pressure (systolic, diastolic and mean), and heart rate.

    Change from baseline in haemodynamics parameters is calculated as the value at Week 12 minus value at baseline.


  • Change From Baseline in N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in NT-pro BNP is calculated as the value at Week 12 minus value at baseline.

  • Clinical Worsening [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Pharmacokinetic (PK) Parameters at Steady State [ Time Frame: pre-dose at Week 2, 4, 8, and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours post-dose at Week 12 or study termination ] [ Designated as safety issue: No ]
    The following PK parameters at the steady state were evaluated: maximum observed concentration during the dosing interval (Cmax), time for maximum observed concentration during the dosing interval (Tmax), area under the plasma concentration-time curve over dosing interval tau for multiple dose (AUCtau), terminal elimination half-life (t1/2), apparent clearance (CL/F) and apparent volume of distribution during the terminal elimination phase (Vz/F) at Week 12/Termination (as data permit), and concentration predose during multiple dosing (Ctrough) at Week 2, 4, 8 and 12/Termination.


Enrollment: 2
Study Start Date: August 2010
Study Completion Date: November 2010
Primary Completion Date: November 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:

  • Has a current diagnosis of symptomatic PAH
  • Has 6MWT distances from 150 to 450 meters and distance

Exclusion Criteria:

  • Previous exposure to an endothelin receptor antagonist
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204853

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:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01204853     History of Changes
Other Study ID Numbers: B1321052
Study First Received: August 6, 2010
Results First Received: October 26, 2011
Last Updated: October 26, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:
sitaxentan sodium hypertension

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

ClinicalTrials.gov processed this record on October 20, 2014