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

Phase 3TerminatedNCT01204853

Pfizer2 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension, Pulmonary

Interventions

SitaxentanDRUG

sitaxentan sodium 100 mg

Eligibility

Sex: ALLMin age: 16 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (2)

Pfizer Investigational Site

Nagoya, Aichi-ken, Japan

Pfizer Investigational Site

Shinjyuku-ku, Tokyo, Japan

Outcomes

Primary Outcomes

Number of Participants With Adverse Events

Number of participants with any adverse events, severe adverse events, serious adverse events

Time frame: 12 weeks

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.

Time frame: 12 weeks

Secondary Outcomes

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.

Time frame: 12 weeks

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.

Time frame: 12 weeks

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.

Time frame: 12 weeks

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.

Data from ClinicalTrials.gov

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