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

NCT ID: NCT01210443

Last Updated: 2011-12-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension, Pulmonary

Keywords

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sitaxentan sodium pulmonary hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sitaxentan treatment

Group Type EXPERIMENTAL

Sitaxentan

Intervention Type DRUG

sitaxentan sodium 100 mg

Interventions

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Sitaxentan

sitaxentan sodium 100 mg

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Nagoya, Aichi-ken, Japan

Site Status

Pfizer Investigational Site

Shinjyuku-ku, Tokyo, Japan

Site Status

Countries

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Japan

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1321053&StudyName=Long-Term%20Open-Label%2C%20Safety%20Study%20Of%20Sitaxentan%20Sodium%20In%20Japanese%20Pulmonary%20Arterial%20Hypertension%20Patients

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Other Identifiers

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B1321053

Identifier Type: -

Identifier Source: org_study_id