Back to resultsA 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients
Primary Purpose
Hypertension, Pulmonary
Status
Terminated
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Sitaxentan
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension, Pulmonary focused on measuring sitaxentan sodium hypertension
Eligibility 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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sitaxentan treatment
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events
Number of participants with any adverse events, severe adverse events, serious adverse events
Change From Baseline in 6-minute Walk Distance
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
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
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)
Change from baseline in NT-pro BNP is calculated as the value at Week 12 minus value at baseline.
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.
Number of Participants With Pharmacokinetic (PK) Parameters at Steady State
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01204853
Brief Title
A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients
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 Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Terminated
Why Stopped
Safety Issue: The trial was prematurely terminated on Dec 9, 2010, due to safety concerns, specifically new emerging evidence of hepatic injury.
Study Start Date
August 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pulmonary
Keywords
sitaxentan sodium hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sitaxentan treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sitaxentan
Intervention Description
sitaxentan sodium 100 mg
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
Number of participants with any adverse events, severe adverse events, serious adverse events
Time Frame
12 weeks
Title
Change From Baseline in 6-minute Walk Distance
Description
Change from baseline in 6-minute walk distance is calculated as the value at Week 12 minus value at baseline.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in WHO Functional Class
Description
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.
Time Frame
12 weeks
Title
Number of Participants With Haemodynamics Parameters
Description
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.
Time Frame
12 weeks
Title
Change From Baseline in N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP)
Description
Change from baseline in NT-pro BNP is calculated as the value at Week 12 minus value at baseline.
Time Frame
12 weeks
Title
Clinical Worsening
Description
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.
Time Frame
12 weeks
Title
Number of Participants With Pharmacokinetic (PK) Parameters at Steady State
Description
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.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shinjyuku-ku
State/Province
Tokyo
Country
Japan
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1321052&StudyName=A%2012%20Week%20Safety%20And%20Efficacy%20Study%20Of%20Sitaxentan%20Sodium%20In%20Japanese%20Pulmonary%20Arterial%20Hypertension%20Patients
Description
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A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients
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