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

Pulmonary Arterial Hypertension Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01445873
• Other study ID #: B1321051
• Status: Completed
• Start date: December 1, 2009
• Est. completion date: March 28, 2011

Study information

• Verified date: August 2020
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 28, 2011
• Est. primary completion date: March 28, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Sitaxentan sodium
Sitaxentan sodium 100 mg / day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Change From Baseline in Mean Right Atrial Pressure	Difference between pre-index and follow-up value.	Baseline to Month 6
Secondary	Change From Baseline in Mean Pulmonary Artery Pressure	Difference between pre-index and follow-up value.	Baseline to Month 6
Secondary	Change From Baseline in Pulmonary Capillary Wedge Pressure	Difference between pre-index and follow-up value.	Baseline to Month 6
Secondary	Change From Baseline in Left Ventricular End Diastolic Pressure	Difference between pre-index and follow-up value.	Baseline to Month 6
Secondary	Change From Baseline in Pulmonary Vascular Resistance	Difference between pre-index and follow-up value.	Baseline to Month 6
Secondary	Change From Baseline in Cardiac Output	Difference between pre-index and follow-up value.	Baseline to Month 6
Secondary	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
Secondary	Change From Baseline in Tricuspid Regurgitant Velocity	Difference between pre-index and follow-up value.	Baseline to Month 6
Secondary	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
Secondary	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
Secondary	Change From Baseline in Percent of Predicted Peak VO2	Difference between pre-index and follow-up value.	Baseline to Month 6
Secondary	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
Secondary	Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Mortality	Number of participants who died during the follow-up period.	Day 1 to Month 6
Secondary	Number of Hospitalizations	All hospitalizations during the follow-up period recorded in medical records.	Day 1 to Month 6
Secondary	Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Lung Transplantation	Number of participants who received an lung transplant during hospitalization.	Day 1 to Month 6
Secondary	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
Secondary	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

External Links

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