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Long-Term Open-Label, Safety 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

About this trial

This is an interventional treatment trial for Hypertension, Pulmonary focused on measuring sitaxentan sodium pulmonary hypertension

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

Secondary Outcome Measures

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.

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.

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).

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.

Full Information

NCT ID

NCT01210443

First Posted

August 11, 2010

Last Updated

November 10, 2011

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01210443

Brief Title

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

Official Title

A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Sitaxentan Sodium In Japanese Subjects With Pulmonary Arterial Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

June 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

November 2010 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Pulmonary

Keywords

sitaxentan sodium pulmonary 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