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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Drug: Sitaxentan sodium

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.

• Study Type: Observational
• Enrollment (Actual): 36

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PAH patients receiving Sitaxentan	Drug: Sitaxentan sodium; Sitaxentan sodium 100 mg / day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Mean Time to Therapy Augmentation	Participants still receiving Thelin with evidence of receipt of another PAH-related therapy (eg. bosentan, sildenafil) not previously received during the study period. Mean time in months to therapy augmentation.	Day 1 to Month 6
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Switching	Participants with evidence of discontinuation of Thelin therapy and evidence of receipt of another PAH-related therapy not previously received during the study period.	Day 1 to Month 6
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Discontinuation	Participants were designated as having discontinued Thelin therapy if there was evidence in the medical records that treatment had been terminated.	Day 1 to Month 6
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Duration	Duration of Thelin therapy based on time from index date (Day 1 of treatment) until the date of discontinuation of Thelin therapy.	Day 1 to Month 6
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Numbers of Therapy-days Dispensed	Duration of Thelin therapy from initial receipt until date of discontinuation of thelin therapy or the end of follow-up, whichever occurred first.	Day 1 to Month 6
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Daily Dosage	Daily dosage of Thelin based on information in the medical record for the baseline visit and all follow-up clinic visits.	Day 1 to Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications	Use of PAH-related medications other than Thelin described by class of agent received.	Day 1 to Month 6
Change From Baseline in World Health Organization (WHO) Functional Class of Pulmonary Hypertension	Class I: no limitation of usual (usl) physical activity (PA); PA does not increase(d) (incr) dyspnea (dys), fatigue (ftg), chest pain (CP), or syncope (syn); Class II: mild limitation of usl PA; no discomfort at rest, but normal PA causes incr dys, ftg, CP, or presyncope (presyn); Class III: marked limitation of PA; no discomfort at rest but < ordinary activity causes incr dys, ftg, CP, or presyn; Class IV: unable to perform any PA at rest; may have signs of right ventricular failure; sys and/or ftg at rest and symptoms are incr by almost any PA.	Baseline to Month 6
Change From Baseline in Mean Right Atrial Pressure	Difference between pre-index and follow-up value.	Baseline to Month 6
Change From Baseline in Mean Pulmonary Artery Pressure	Difference between pre-index and follow-up value.	Baseline to Month 6
Change From Baseline in Pulmonary Capillary Wedge Pressure	Difference between pre-index and follow-up value.	Baseline to Month 6
Change From Baseline in Left Ventricular End Diastolic Pressure	Difference between pre-index and follow-up value.	Baseline to Month 6
Change From Baseline in Pulmonary Vascular Resistance	Difference between pre-index and follow-up value.	Baseline to Month 6
Change From Baseline in Cardiac Output	Difference between pre-index and follow-up value.	Baseline to Month 6
Change From Baseline in Tei Index	Difference between pre-index and follow-up value. Combined myocardial performance index calculated by adding isovolumic contraction time and isovolumic relaxation time and dividing the resulting sum by ejection time.	Baseline to Month 6
Change From Baseline in Tricuspid Regurgitant Velocity	Difference between pre-index and follow-up value.	Baseline to Month 6
Change From Baseline in the Total Distance Walked During 6 Minute Walk Test (6MWT)	6MWT was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety. Difference between pre-index and follow-up value.	Baseline to Month 6
Change From Baseline in Borg Dyspnoea Score	Borg dyspnoea scale is a 10-point scale where following scores stands for severity of dyspnoea: 0 (no breathlessness at all); 0.5 (very very slight [just noticeable]); 1 (very slight); 2 (slight breathlessness); 3 (moderate); 4 (some what severe); 5 (severe breathlessness); 7 (very severe breathlessness); 9 (very very severe [almost maximum] and 10 (maximum). Difference between pre-index and follow-up value.	Baseline to Month 6
Change From Baseline in Percent of Predicted Peak VO2	Difference between pre-index and follow-up value.	Baseline to Month 6
Pulmonary Arterial Hypertension (PAH) Severity and Functional Status: Time to Clinical Worsening	Occurrence of any of the following: death, unplanned PAH-related hospitalization, initiation of epoprostenol, arterial septostomy, lung or heart/lung transplantation, ≥15% decrease from baseline in 6 minute walk test, signs/symptoms of right sided heart failure, and/or worsening WHO functional class.	Day 1 to Month 6
Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Mortality	Number of participants who died during the follow-up period.	Day 1 to Month 6
Number of Hospitalizations	All hospitalizations during the follow-up period recorded in medical records.	Day 1 to Month 6
Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Lung Transplantation	Number of participants who received an lung transplant during hospitalization.	Day 1 to Month 6
Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Heart/Lung Transplantation	Number of participants who received an heart/lung transplant during hospitalization.	Day 1 to Month 6
Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Atrial Septostomy	Number of participants who received an atrial septostomy (balloon or blade) during hospitalization.	Day 1 to Month 6

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2009
• Primary Completion (Actual): March 28, 2011
• Study Completion (Actual): March 28, 2011

Study Registration Dates

• First Submitted: September 30, 2011
• First Submitted That Met QC Criteria: September 30, 2011
• First Posted (Estimate): October 4, 2011

Study Record Updates

• Last Update Posted (Actual): September 1, 2020
• Last Update Submitted That Met QC Criteria: August 18, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Pulmonary arterial hypertension; Thelin; sitaxentan sodium
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Molecular Mechanisms of Pharmacological Action; Endothelin Receptor Antagonists; Sitaxsentan
• Other Study ID Numbers: B1321051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.