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

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Nagoya, Aichi, Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Has a current diagnosis of symptomatic PAH

- Has 6MWT distances from 150 to 450 meters and distance

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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 minutes at Screening.

NCT01204853
Pfizer
Terminated
A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients

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A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients
A Phase 3, Multi-Center, Open Label Study To Evaluate The Safety And Efficacy Of Sitaxentan Sodium In Japanese Subjects With Pulmonary Arterial Hypertension
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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hypertension, Pulmonary
Drug: Sitaxentan
sitaxentan sodium 100 mg
Experimental: Sitaxentan treatment
Intervention: Drug: Sitaxentan
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
November 2010
November 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
16 Years to 80 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01204853
B1321052
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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