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Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH)

Last updated on December 5, 2018

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

- Idiopathic PAH, or PAH secondary to connective tissue disease

- Receipt of Thelin for treatment of PAH

- 6 months of follow-up (except in the event of death) subsequent to initial receipt of
Thelin

- Minimum of one clinic visit documented in the medical record during the 6-month period
subsequent to initial receipt of Thelin

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

- Participation in any investigational study of Thelin or any other medication for the
treatment of PAH during the period beginning 6 months prior to initial receipt of
Thelin and ending 6 months subsequent to such receipt

- Receipt of Thelin prior to January 11, 2005 (i.e., the date following the last day on
which patients could be enrolled in double-blind treatment in STRIDE-1, STRIDE-2,
and/or STRIDE-6); or

- Known contraindications to Thelin therapy (i.e., known hypersensitivity to sitaxsentan
or any of its excipients; mild-to-severe hepatic impairment [Child-Pugh Class A-C];
elevated aminotransferases prior to initiation of treatment, defined as aspartate
aminotransferase [AST] and/or alanine aminotransferase [ALT] >3 times upper limit of
normal [ULN]; concomitant use of cyclosporin A; lactation)

NCT01445873
Pfizer
Completed
Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH)

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Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH)
Non-Interventional (NI) Drug Study Protocol: Three-Country Pilot Study For Retrospective Chart Review Of Effectiveness Of Thelin® (Sitaxsentan) In Patients With Pulmonary Arterial Hypertension (PAH)
The objectives of this study are to develop research methods and corresponding materials for a study of the effectiveness of sitaxentan sodium (Thelin) in "real-world" settings; to pilot test these methods at three study centers in Europe; and to refine and finalize research methods and corresponding materials for possible use in a follow-on, full-scale examination of the effectiveness of sitaxentan sodium (Thelin) in "real-world" settings.
At each centre, approximately 12-15 Pulmonary Arterial Hypertension (PAH) consecutive patients who have received Thelin and who meet all other study entry criteria.
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
Patients with Pulmonary Arterial Hypertension (PAH) (Idiopathic or secondary to connective tissue disease), receiving sitaxentan sodium (Thelin) for treatment of their PAH for at least 6 months.
Pulmonary Arterial Hypertension
Drug: Sitaxentan sodium
Sitaxentan sodium 100 mg / day
PAH patients receiving Sitaxentan
Intervention: Drug: Sitaxentan sodium
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
March 2011
March 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Idiopathic PAH, or PAH secondary to connective tissue disease
  • Receipt of Thelin for treatment of PAH
  • 6 months of follow-up (except in the event of death) subsequent to initial receipt of Thelin
  • Minimum of one clinic visit documented in the medical record during the 6-month period subsequent to initial receipt of Thelin

Exclusion Criteria:

  • Participation in any investigational study of Thelin or any other medication for the treatment of PAH during the period beginning 6 months prior to initial receipt of Thelin and ending 6 months subsequent to such receipt
  • Receipt of Thelin prior to January 11, 2005 (i.e., the date following the last day on which patients could be enrolled in double-blind treatment in STRIDE-1, STRIDE-2, and/or STRIDE-6); or
  • Known contraindications to Thelin therapy (i.e., known hypersensitivity to sitaxsentan or any of its excipients; mild-to-severe hepatic impairment [Child-Pugh Class A-C]; elevated aminotransferases prior to initiation of treatment, defined as aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT] >3 times upper limit of normal [ULN]; concomitant use of cyclosporin A; lactation)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01445873
B1321051
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2011

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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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