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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01445873
• Date of registration: 30/09/2011
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH)
• Scientific 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)
• Date of first enrolment: December 1, 2009
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01445873
• Study type: Observational

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Sitaxentan sodium

Primary Outcome(s)

Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Mean Time to Therapy Augmentation [Time Frame: Day 1 to Month 6]

Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Switching [Time Frame: Day 1 to Month 6]

Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Daily Dosage [Time Frame: Day 1 to Month 6]

Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Numbers of Therapy-days Dispensed [Time Frame: Day 1 to Month 6]

Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Discontinuation [Time Frame: Day 1 to Month 6]

Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Duration [Time Frame: Day 1 to Month 6]

Secondary Outcome(s)

Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications [Time Frame: Day 1 to Month 6]

Change From Baseline in Borg Dyspnoea Score [Time Frame: Baseline to Month 6]

Change From Baseline in Left Ventricular End Diastolic Pressure [Time Frame: Baseline to Month 6]

Change From Baseline in Pulmonary Capillary Wedge Pressure [Time Frame: Baseline to Month 6]

Change From Baseline in Tricuspid Regurgitant Velocity [Time Frame: Baseline to Month 6]

Change From Baseline in World Health Organization (WHO) Functional Class of Pulmonary Hypertension [Time Frame: Baseline to Month 6]

Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Heart/Lung Transplantation [Time Frame: Day 1 to Month 6]

Change From Baseline in Cardiac Output [Time Frame: Baseline to Month 6]

Pulmonary Arterial Hypertension (PAH) Severity and Functional Status: Time to Clinical Worsening [Time Frame: Day 1 to Month 6]

Change From Baseline in Tei Index [Time Frame: Baseline to Month 6]

Change From Baseline in the Total Distance Walked During 6 Minute Walk Test (6MWT) [Time Frame: Baseline to Month 6]

Change From Baseline in Mean Right Atrial Pressure [Time Frame: Baseline to Month 6]

Change From Baseline in Percent of Predicted Peak VO2 [Time Frame: Baseline to Month 6]

Change From Baseline in Pulmonary Vascular Resistance [Time Frame: Baseline to Month 6]

Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Lung Transplantation [Time Frame: Day 1 to Month 6]

Change From Baseline in Mean Pulmonary Artery Pressure [Time Frame: Baseline to Month 6]

Number of Hospitalizations [Time Frame: Day 1 to Month 6]

Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Atrial Septostomy [Time Frame: Day 1 to Month 6]

Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Mortality [Time Frame: Day 1 to Month 6]

Secondary ID(s)

B1321051

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 08/06/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01445873