- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01445873
Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH)
18. srpna 2020 aktualizováno: 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.
Přehled studie
Detailní popis
At each centre, approximately 12-15 Pulmonary Arterial Hypertension (PAH) consecutive patients who have received Thelin and who meet all other study entry criteria.
Typ studie
Pozorovací
Zápis (Aktuální)
36
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
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.
Popis
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)
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
---|---|
PAH patients receiving Sitaxentan
|
Sitaxentan sodium 100 mg / day
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Mean Time to Therapy Augmentation
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications
Časové okno: 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
Časové okno: 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
Časové okno: Baseline to Month 6
|
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
Change From Baseline in Mean Pulmonary Artery Pressure
Časové okno: Baseline to Month 6
|
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
Change From Baseline in Pulmonary Capillary Wedge Pressure
Časové okno: 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
Časové okno: Baseline to Month 6
|
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
Change From Baseline in Pulmonary Vascular Resistance
Časové okno: Baseline to Month 6
|
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
Change From Baseline in Cardiac Output
Časové okno: Baseline to Month 6
|
Difference between pre-index and follow-up value.
|
Baseline to Month 6
|
Change From Baseline in Tei Index
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Day 1 to Month 6
|
Number of participants who died during the follow-up period.
|
Day 1 to Month 6
|
Number of Hospitalizations
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Day 1 to Month 6
|
Number of participants who received an atrial septostomy (balloon or blade) during hospitalization.
|
Day 1 to Month 6
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. prosince 2009
Primární dokončení (Aktuální)
28. března 2011
Dokončení studie (Aktuální)
28. března 2011
Termíny zápisu do studia
První předloženo
30. září 2011
První předloženo, které splnilo kritéria kontroly kvality
30. září 2011
První zveřejněno (Odhad)
4. října 2011
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
1. září 2020
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
18. srpna 2020
Naposledy ověřeno
1. srpna 2020
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- B1321051
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu IPD
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.
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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