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A Blinded Study to Evaluate Effect on Atrial Fibrillation Burden in Patients With Paroxysmal Atrial Fibrillation
29 juli 2019 bijgewerkt door: Bristol-Myers Squibb
A Randomized, Double-Blind, Placebo-Controlled Parallel Arm Study to Evaluate the Safety, Tolerability, and Effect on Atrial Fibrillation Burden of BMS-919373 in Patients With Paroxysmal Atrial Fibrillation
The purpose of this study is to evaluate the effect of BMS-919373 on atrial fibrillation (AF) through its effect on AF burden (AFB), or the percent of time in AF, in subjects with paroxysmal AF (pAF) when administered orally at a range of doses (2 mg once daily (QD), 5 mg QD, 12 mg QD following a 1-week period of loading doses of 3 mg QD, 8 mg QD and 20 mg QD, respectively) for a total of 4 weeks.
It is hypothesized that treatment with BMS-919373 will reduce AF burden as compared to baseline relative to placebo.
Studie Overzicht
Toestand
Beëindigd
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Primary Purpose: Protocol designed to assess, by the use of long term non-invasive beat-to-beat monitoring with the SEEQ Mobile Cardiac Telemetry (MCT) system, the effect of BMS-919373 on the percent change from baseline relative to placebo of atrial fibrillation burden in subjects with paroxysmal atrial fibrillation.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
158
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Quebec, Canada, G1V 4G5
- Local Institution
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Alberta
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Edmonton, Alberta, Canada, T6G 2B7
- Local Institution
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British Columbia
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New Westminster, British Columbia, Canada, V3L 3W4
- Fraser Clinical Trials Inc.
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Ontario
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Cambridge, Ontario, Canada, N1R 7R1
- Local Institution
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Grimsby, Ontario, Canada, L3M 1P3
- Dr. Andy S.C. Lam Medicine Professional
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London, Ontario, Canada, N6G 2V4
- Stroke Prevention & Artherosclerosis Research Centre
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Newmarket, Ontario, Canada
- Local Institution
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Oshawa, Ontario, Canada, L1J 2J9
- Local Institution
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Oshawa, Ontario, Canada, L1J 2K1
- King Street Cardiology
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Toronto, Ontario, Canada, M3M 3E5
- Local Institution
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Waterloo, Ontario, Canada, N2T 0C1
- Local Institution
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Quebec
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Greenfield Park, Quebec, Canada, J4V 2G8
- Viacar Recherche Clinique
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Montreal, Quebec, Canada, H1T 1C8
- Local Institution
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Montreal, Quebec, Canada, H2W 1T8
- Local Institution
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Terrebonne, Quebec, Canada, J6V 2H2
- Csss Du Sud De Lanaudiere-Hopital Pierre-Le Gardeur
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California
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Anaheim, California, Verenigde Staten, 92801
- Oracle Clinical Research, Inc.
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Anaheim, California, Verenigde Staten, 92801
- Cardiology Consultants Of Orange County Med. Group Inc
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Costa Mesa, California, Verenigde Staten, 92626
- WCCT Global, LLC
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Long Beach, California, Verenigde Staten, 90822
- Long Beach VA Medical Center
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Moreno Valley, California, Verenigde Staten, 92553
- Spectrum Clinical Research
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Connecticut
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Waterbury, Connecticut, Verenigde Staten, 06708
- Chase Medical Research, LLC
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Florida
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Cooper City, Florida, Verenigde Staten, 33024
- ALL Medical Research, LLC
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Gainesville, Florida, Verenigde Staten, 32605
- The Cardiac And Vascular Institute Research Foundation, Llc
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Lake Worth, Florida, Verenigde Staten, 33462
- Acrc Cardiology
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Largo, Florida, Verenigde Staten, 33770
- The Heart Institute at Largo
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Georgia
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Columbus, Georgia, Verenigde Staten, 31904
- Columbus Regional Research Institute
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Indiana
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Anderson, Indiana, Verenigde Staten, 46011
- Community Clinical Research Center
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Kansas
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Overland Park, Kansas, Verenigde Staten, 66209
- Midwest Heart And Vascular Specialists, Llc.
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Louisiana
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Alexandria, Louisiana, Verenigde Staten, 71301
- Cambridge Medical Trials
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Oklahoma
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Tulsa, Oklahoma, Verenigde Staten, 74136
- Castlerock Clinical Research Consultants, Llc
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Pennsylvania
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Camp Hill, Pennsylvania, Verenigde Staten, 17011
- Capital Area Research, LLC
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Tennessee
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Tullahoma, Tennessee, Verenigde Staten, 37388
- Tennessee Center for Clinical Trials
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Texas
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Austin, Texas, Verenigde Staten
- Local Institution
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Austin, Texas, Verenigde Staten, 78705
- Local Institution
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Utah
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Layton, Utah, Verenigde Staten, 84041
- Utah Cardiology P.C
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Signed informed consent
- Paroxysmal Atrial Fibrillation (pAF) with available documentation of AF and reporting symptoms within 6 months prior to screening
- Able to tolerate withdrawal of antiarrhythmic therapy (rhythm control)
- Echocardiographically measured left ventricular ejection fraction (LVEF) ≥40%,measured within 12 months of enrollment
- Echocardiographically measured left atrial (LA) diameter ≤ 5.0 cm, measured within 12 months of enrollment
Exclusion Criteria:
- Women of childbearing potential
- AFB < 3% or > 70%, during both screening periods independently
- Permanent or persistent Atrial Fibrillation
- Cardioversion within 3 months of study drug administration
- Stroke within 12 months of study drug administration
- TIA within 12 months of study drug administration
- Heart failure of NYHA class III or greater (symptoms of heart failure at rest or with minimal exertion)
- Heart failure of NYHA class II (symptoms of heart failure with routine levels of exertion)with ejection fraction <40% as measured by echocardiography at any time within 12 months of study enrollment (i.e. additional ejection fraction measurements ≥ 40% over this period will not counter this exclusion)
- Valvular heart disease (including any valvular insufficiency or stenosis greater than"mild")
- Ablation within 3 months of study enrollment
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Placebo-vergelijker: Arm A: Placebo (Matching with BMS-919373)
Placebo (Matching with BMS-919373) 0 mg tablets orally once daily for approximately 28 Days
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Experimenteel: Arm B: BMS-919373
BMS-919373 3 mg tablets orally once daily for approximately 28 days
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Experimenteel: Arm C: BMS-919373
BMS-919373 5 mg tablets orally once daily for approximately 28 days
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Experimenteel: Arm D: BMS-919373
BMS-919373 12 mg tablets orally once daily for approximately 28 days
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Percent Change From Baseline in Atrial Fibrillation Burden (AFB) as Assessed by SEEQ Mobile Cardiac Telemetry (MCT) System
Tijdsspanne: Day 8 to Day 29
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AFB is defined as the percent of time spent in atrial fibrillation (AF).
AFB will be assessed by use of long term non- invasive beat-to-beat monitoring with the SEEQ MCT system.
This technology consists of a low-profile adhesive patch that has been approved for continuous use for up to 30 days.
The patch is able to continuously record electrocardiographic signals and, in conjunction with a wirelessly connected portable cellular communications device, transmit these signals for real-time analysis, including atrial and ventricular arrhythmias and AFB.
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Day 8 to Day 29
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs and Death
Tijdsspanne: Up to Day 50
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An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.
An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect.
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Up to Day 50
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Maximum Observed Concentarion (Cmax) of BMS-919373
Tijdsspanne: Day 1 and Day 22: Predose 1, 2, and 4 hours postdose
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Cmax is defined as the maximum observed concentration of BMS-919373.
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Day 1 and Day 22: Predose 1, 2, and 4 hours postdose
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Trough Observed Concentration (Cmin) of BMS-919373
Tijdsspanne: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
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Ctrough is defined as the minimum estimated plasma concentration at steady state.
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Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
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Oral Clearance (CL/F) of BMS-919373
Tijdsspanne: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
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Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
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Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
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Central Volume of Distribution (Vc/F) of BMS-919373
Tijdsspanne: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
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Volume of distribution is defined as the theoretical volume in which the total amount of drug is uniformly distributed to produce the desired plasma concentration of a drug.
Vc/F is a hypothetical volume into which a drug initially distributes upon administration.
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Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
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Absorption Rate Constant (Ka) of BMS-919373
Tijdsspanne: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
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Ka is the absorption rate constant.
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Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
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Average Concentration (Cavg) of BMS-919373 at Steady State
Tijdsspanne: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
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Cavg is defines as the average concentration at steady state.
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Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
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Area Under the Concentration-time Curve (AUC) at Steady State of BMS-919373
Tijdsspanne: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
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AUC is defined as the area under the concentration-time curve at steady state.
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Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
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Time to First Atrial Fibrillation Recurrence (TTFR) (Symptomatic or Asymptomatic)
Tijdsspanne: Day 8 to Day 29
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The TTFR is defined as the time to the first MCT-recorded AF episode after the first loading dose on Day 1. MCT will provide both "System-triggered" and "Patient-triggered" results and report them separately.
"System-triggered" results will include both symptomatic and asymptomatic findings, while "Patient-triggered" results will be the symptomatic ones triggered to report by patients.
The analysis will be done both for "System-triggered" and for "Patient-triggered" results.
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Day 8 to Day 29
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Total Number of Atrial Fibrillation Episodes
Tijdsspanne: Day 8 to Day 29
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The total number AF episodes were derived from AF episode histogram data over the monitoring period.
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Day 8 to Day 29
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Average Duration of Atrial Fibrillation Per Episode
Tijdsspanne: Day 8 to Day 29
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The average duration of AF per episode was calculated from the total time a participant in AF and the total number of AF episodes over the monitoring period.
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Day 8 to Day 29
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
25 juli 2014
Primaire voltooiing (Werkelijk)
1 juni 2016
Studie voltooiing (Werkelijk)
1 juni 2016
Studieregistratiedata
Eerst ingediend
12 mei 2014
Eerst ingediend dat voldeed aan de QC-criteria
3 juni 2014
Eerst geplaatst (Schatting)
5 juni 2014
Updates van studierecords
Laatste update geplaatst (Werkelijk)
31 juli 2019
Laatste update ingediend die voldeed aan QC-criteria
29 juli 2019
Laatst geverifieerd
1 juli 2019
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CV205-005
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op BMS-919373
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Bristol-Myers SquibbWervingLupusVerenigde Staten, Argentinië, Duitsland, Mexico, Polen, Roemenië, Bulgarije, Spanje
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Bristol-Myers SquibbVoltooidIdiopathische longfibroseVerenigde Staten, Mexico, Australië, Colombia, Chili, Peru