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Completed

NCT Number: NCT01445873

Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) 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.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sitaxentan sodium

Drug

Sitaxentan sodium 100 mg / day

Primary outcomes

  1. Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Mean Time to Therapy Augmentation

    Time frame: Day 1 to Month 6

    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.

  2. Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Switching

    Time frame: Day 1 to Month 6

    Participants with evidence of discontinuation of Thelin therapy and evidence of receipt of another PAH-related therapy not previously received during the study period.

  3. Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Discontinuation

    Time frame: Day 1 to Month 6

    Participants were designated as having discontinued Thelin therapy if there was evidence in the medical records that treatment had been terminated.

  4. Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Duration

    Time frame: Day 1 to Month 6

    Duration of Thelin therapy based on time from index date (Day 1 of treatment) until the date of discontinuation of Thelin therapy.

  5. Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Numbers of Therapy-days Dispensed

    Time frame: Day 1 to Month 6

    Duration of Thelin therapy from initial receipt until date of discontinuation of thelin therapy or the end of follow-up, whichever occurred first.

  6. Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Daily Dosage

    Time frame: Day 1 to Month 6

    Daily dosage of Thelin based on information in the medical record for the baseline visit and all follow-up clinic visits.

Secondary outcomes

  1. Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications

    Time frame: Day 1 to Month 6

    Use of PAH-related medications other than Thelin described by class of agent received.

  2. Change From Baseline in World Health Organization (WHO) Functional Class of Pulmonary Hypertension

    Time frame: Baseline to Month 6

    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.

  3. Change From Baseline in Mean Right Atrial Pressure

    Time frame: Baseline to Month 6

    Difference between pre-index and follow-up value.

  4. Change From Baseline in Mean Pulmonary Artery Pressure

    Time frame: Baseline to Month 6

    Difference between pre-index and follow-up value.

  5. Change From Baseline in Pulmonary Capillary Wedge Pressure

    Time frame: Baseline to Month 6

    Difference between pre-index and follow-up value.

  6. Change From Baseline in Left Ventricular End Diastolic Pressure

    Time frame: Baseline to Month 6

    Difference between pre-index and follow-up value.

  7. Change From Baseline in Pulmonary Vascular Resistance

    Time frame: Baseline to Month 6

    Difference between pre-index and follow-up value.

  8. Change From Baseline in Cardiac Output

    Time frame: Baseline to Month 6

    Difference between pre-index and follow-up value.

  9. Change From Baseline in Tei Index

    Time frame: Baseline to Month 6

    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.

  10. Change From Baseline in Tricuspid Regurgitant Velocity

    Time frame: Baseline to Month 6

    Difference between pre-index and follow-up value.

  11. Change From Baseline in the Total Distance Walked During 6 Minute Walk Test (6MWT)

    Time frame: Baseline to Month 6

    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.

  12. Change From Baseline in Borg Dyspnoea Score

    Time frame: Baseline to Month 6

    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.

  13. Change From Baseline in Percent of Predicted Peak VO2

    Time frame: Baseline to Month 6

    Difference between pre-index and follow-up value.

  14. Pulmonary Arterial Hypertension (PAH) Severity and Functional Status: Time to Clinical Worsening

    Time frame: Day 1 to Month 6

    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.

  15. Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Mortality

    Time frame: Day 1 to Month 6

    Number of participants who died during the follow-up period.

  16. Number of Hospitalizations

    Time frame: Day 1 to Month 6

    All hospitalizations during the follow-up period recorded in medical records.

  17. Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Lung Transplantation

    Time frame: Day 1 to Month 6

    Number of participants who received an lung transplant during hospitalization.

  18. Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Heart/Lung Transplantation

    Time frame: Day 1 to Month 6

    Number of participants who received an heart/lung transplant during hospitalization.

  19. Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Atrial Septostomy

    Time frame: Day 1 to Month 6

    Number of participants who received an atrial septostomy (balloon or blade) during hospitalization.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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)

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 4, 2011
Registry last updated
Sep 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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