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

Last updated on November 12, 2019

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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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Descriptive Information
Brief TitlePilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH)
Official TitleNon-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)
Brief SummaryThe 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.
Detailed DescriptionAt each centre, approximately 12-15 Pulmonary Arterial Hypertension (PAH) consecutive patients who have received Thelin and who meet all other study entry criteria.
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationPatients 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.
ConditionPulmonary Arterial Hypertension
InterventionDrug: Sitaxentan sodium
Sitaxentan sodium 100 mg / day
Study Groups/CohortsPAH patients receiving Sitaxentan
Intervention: Drug: Sitaxentan sodium
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: September 30, 2011)
36
Original Actual EnrollmentSame as current
Actual Study Completion DateMarch 2011
Actual Primary Completion DateMarch 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01445873
Other Study ID NumbersB1321051
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2011

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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