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

18. august 2020 opdateret af: Pfizer

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

36

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
PAH patients receiving Sitaxentan
Medicin: Sitaxentan sodium
Sitaxentan sodium 100 mg / day

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Mean Time to Therapy Augmentation
Tidsramme: 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.
Day 1 to Month 6
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Switching
Tidsramme: 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.
Day 1 to Month 6
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Discontinuation
Tidsramme: 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.
Day 1 to Month 6
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Duration
Tidsramme: 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.
Day 1 to Month 6
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Numbers of Therapy-days Dispensed
Tidsramme: 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.
Day 1 to Month 6
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Daily Dosage
Tidsramme: 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.
Day 1 to Month 6

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications
Tidsramme: Day 1 to Month 6
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
Tidsramme: 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.
Baseline to Month 6
Change From Baseline in Mean Right Atrial Pressure
Tidsramme: Baseline to Month 6
Difference between pre-index and follow-up value.
Baseline to Month 6
Change From Baseline in Mean Pulmonary Artery Pressure
Tidsramme: Baseline to Month 6
Difference between pre-index and follow-up value.
Baseline to Month 6
Change From Baseline in Pulmonary Capillary Wedge Pressure
Tidsramme: Baseline to Month 6
Difference between pre-index and follow-up value.
Baseline to Month 6
Change From Baseline in Left Ventricular End Diastolic Pressure
Tidsramme: Baseline to Month 6
Difference between pre-index and follow-up value.
Baseline to Month 6
Change From Baseline in Pulmonary Vascular Resistance
Tidsramme: Baseline to Month 6
Difference between pre-index and follow-up value.
Baseline to Month 6
Change From Baseline in Cardiac Output
Tidsramme: Baseline to Month 6
Difference between pre-index and follow-up value.
Baseline to Month 6
Change From Baseline in Tei Index
Tidsramme: 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.
Baseline to Month 6
Change From Baseline in Tricuspid Regurgitant Velocity
Tidsramme: Baseline to Month 6
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)
Tidsramme: 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.
Baseline to Month 6
Change From Baseline in Borg Dyspnoea Score
Tidsramme: 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.
Baseline to Month 6
Change From Baseline in Percent of Predicted Peak VO2
Tidsramme: Baseline to Month 6
Difference between pre-index and follow-up value.
Baseline to Month 6
Pulmonary Arterial Hypertension (PAH) Severity and Functional Status: Time to Clinical Worsening
Tidsramme: 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.
Day 1 to Month 6
Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Mortality
Tidsramme: Day 1 to Month 6
Number of participants who died during the follow-up period.
Day 1 to Month 6
Number of Hospitalizations
Tidsramme: Day 1 to Month 6
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
Tidsramme: Day 1 to Month 6
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
Tidsramme: Day 1 to Month 6
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
Tidsramme: Day 1 to Month 6
Number of participants who received an atrial septostomy (balloon or blade) during hospitalization.
Day 1 to Month 6

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. december 2009

Primær færdiggørelse (Faktiske)

28. marts 2011

Studieafslutning (Faktiske)

28. marts 2011

Datoer for studieregistrering

Først indsendt

30. september 2011

Først indsendt, der opfyldte QC-kriterier

30. september 2011

Først opslået (Skøn)

4. oktober 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. september 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. august 2020

Sidst verificeret

1. august 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B1321051

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Pulmonal arteriel hypertension

Kliniske forsøg med Sitaxentan sodium

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Betingelser

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Placeringer

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