Clinical trial NCT01445873: Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary arterial hypertension
sitaxentan sodium
Thelin
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-10-04
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: At each centre, approximately 12-15 Pulmonary Arterial Hypertension (PAH) consecutive patients who have received Thelin and who meet all other study entry criteria.

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)

Primary outcomes:
measure: Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Mean Time to Therapy Augmentation
timeFrame: Day 1 to Month 6
measure: Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Switching
timeFrame: Day 1 to Month 6
measure: Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Discontinuation
timeFrame: Day 1 to Month 6
measure: Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Duration
timeFrame: Day 1 to Month 6
measure: Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Numbers of Therapy-days Dispensed
timeFrame: Day 1 to Month 6
measure: Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Daily Dosage
timeFrame: Day 1 to Month 6
Secondary outcomes:
measure: Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications
timeFrame: Day 1 to Month 6
measure: Change From Baseline in World Health Organization (WHO) Functional Class of Pulmonary Hypertension
timeFrame: Baseline to Month 6
measure: Change From Baseline in Mean Right Atrial Pressure
timeFrame: Baseline to Month 6
measure: Change From Baseline in Mean Pulmonary Artery Pressure
timeFrame: Baseline to Month 6
measure: Change From Baseline in Pulmonary Capillary Wedge Pressure
timeFrame: Baseline to Month 6
measure: Change From Baseline in Left Ventricular End Diastolic Pressure
timeFrame: Baseline to Month 6
measure: Change From Baseline in Pulmonary Vascular Resistance
timeFrame: Baseline to Month 6
measure: Change From Baseline in Cardiac Output
timeFrame: Baseline to Month 6
measure: Change From Baseline in Tei Index
timeFrame: Baseline to Month 6
measure: Change From Baseline in Tricuspid Regurgitant Velocity
timeFrame: Baseline to Month 6
measure: Change From Baseline in the Total Distance Walked During 6 Minute Walk Test (6MWT)
timeFrame: Baseline to Month 6
measure: Change From Baseline in Borg Dyspnoea Score
timeFrame: Baseline to Month 6
measure: Change From Baseline in Percent of Predicted Peak VO2
timeFrame: Baseline to Month 6
measure: Pulmonary Arterial Hypertension (PAH) Severity and Functional Status: Time to Clinical Worsening
timeFrame: Day 1 to Month 6
measure: Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Mortality
timeFrame: Day 1 to Month 6
measure: Number of Hospitalizations
timeFrame: Day 1 to Month 6
measure: Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Lung Transplantation
timeFrame: Day 1 to Month 6
measure: Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Heart/Lung Transplantation
timeFrame: Day 1 to Month 6
measure: Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Atrial Septostomy
timeFrame: Day 1 to Month 6
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: