A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01204853
Recruitment Status : Terminated (Safety Issue: The trial was prematurely terminated on Dec 9, 2010, due to safety concerns, specifically new emerging evidence of hepatic injury.)
First Posted : September 17, 2010
Results First Posted : December 1, 2011
Last Update Posted : December 1, 2011
Information provided by (Responsible Party):

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 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 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 Safety And Efficacy Of Sitaxentan Sodium In Japanese Subjects With Pulmonary Arterial Hypertension
Study Start Date : August 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

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

Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: 12 weeks ]
    Number of participants with any adverse events, severe adverse events, serious adverse events

  2. Change From Baseline in 6-minute Walk Distance [ Time Frame: 12 weeks ]
    Change from baseline in 6-minute walk distance is calculated as the value at Week 12 minus value at baseline.

Secondary Outcome Measures :
  1. Change From Baseline in WHO Functional Class [ Time Frame: 12 weeks ]
    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.

  2. Number of Participants With Haemodynamics Parameters [ Time Frame: 12 weeks ]

    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.

  3. Change From Baseline in N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP) [ Time Frame: 12 weeks ]
    Change from baseline in NT-pro BNP is calculated as the value at Week 12 minus value at baseline.

  4. Clinical Worsening [ Time Frame: 12 weeks ]
    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.

  5. 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 ]
    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.

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01204853

Pfizer Investigational Site
Nagoya, Aichi, Japan
Pfizer Investigational Site
Shinjyuku-ku, Tokyo, Japan
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT01204853     History of Changes
Other Study ID Numbers: B1321052
First Posted: September 17, 2010    Key Record Dates
Results First Posted: December 1, 2011
Last Update Posted: December 1, 2011
Last Verified: October 2011

Keywords provided by Pfizer:
sitaxentan sodium hypertension

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action