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:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01204853
First received: August 6, 2010
Last updated: October 26, 2011
Last verified: October 2011
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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 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, Pulmonary Hypertension Lung Diseases |
Respiratory Tract Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013