Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients

Phase 3TerminatedNCT01210443

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 long-term 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

2

Conditions

Hypertension, Pulmonary

Interventions

sitaxentan sodium 100 mg

Eligibility

Sex: ALLMin age: 16 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject who completed the B1321052 study as planned. Exclusion Criteria: * 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: Up to 22 days (last participant discontinuation)

Secondary Outcomes

Percentage of Participants With 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.

Time frame: Up to 22 days (last participant discontinuation)

Change From Baseline in 6-Minute Walk Distance

Change from baseline in 6-minute walk distance is calculated as the value at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48) minus value at baseline.

Time frame: Up to 22 days (last participant discontinuation)

Percentage of Participants With 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 is summarised with percentage of participants at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48).

Time frame: Up to 22 days (last participant discontinuation)

Change From Baseline in Blood Concentration of N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP)

Change from baseline in Blood Concentration of NT-pro BNP is calculated as the value at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48) minus value at baseline.

Time frame: Up to 22 days (last participant discontinuation)

Data from ClinicalTrials.gov

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NCT01210443 - Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients | Crick | Crick