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A Blinded Study to Evaluate Effect on Atrial Fibrillation Burden in Patients With Paroxysmal Atrial Fibrillation

29 luglio 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

158

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Canada
      • Quebec, Canada, G1V 4G5
        • Local Institution
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Local Institution
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W4
        • Fraser Clinical Trials Inc.
    • Ontario
      • Cambridge, Ontario, Canada, N1R 7R1
        • Local Institution
      • Grimsby, Ontario, Canada, L3M 1P3
        • Dr. Andy S.C. Lam Medicine Professional
      • London, Ontario, Canada, N6G 2V4
        • Stroke Prevention & Artherosclerosis Research Centre
      • Newmarket, Ontario, Canada
        • Local Institution
      • Oshawa, Ontario, Canada, L1J 2J9
        • Local Institution
      • Oshawa, Ontario, Canada, L1J 2K1
        • King Street Cardiology
      • Toronto, Ontario, Canada, M3M 3E5
        • Local Institution
      • Waterloo, Ontario, Canada, N2T 0C1
        • Local Institution
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2G8
        • Viacar Recherche Clinique
      • Montreal, Quebec, Canada, H1T 1C8
        • Local Institution
      • Montreal, Quebec, Canada, H2W 1T8
        • Local Institution
      • Terrebonne, Quebec, Canada, J6V 2H2
        • Csss Du Sud De Lanaudiere-Hopital Pierre-Le Gardeur
  • Stati Uniti
    • California
      • Anaheim, California, Stati Uniti, 92801
        • Oracle Clinical Research, Inc.
      • Anaheim, California, Stati Uniti, 92801
        • Cardiology Consultants Of Orange County Med. Group Inc
      • Costa Mesa, California, Stati Uniti, 92626
        • WCCT Global, LLC
      • Long Beach, California, Stati Uniti, 90822
        • Long Beach VA Medical Center
      • Moreno Valley, California, Stati Uniti, 92553
        • Spectrum Clinical Research
    • Connecticut
      • Waterbury, Connecticut, Stati Uniti, 06708
        • Chase Medical Research, LLC
    • Florida
      • Cooper City, Florida, Stati Uniti, 33024
        • ALL Medical Research, LLC
      • Gainesville, Florida, Stati Uniti, 32605
        • The Cardiac And Vascular Institute Research Foundation, Llc
      • Lake Worth, Florida, Stati Uniti, 33462
        • Acrc Cardiology
      • Largo, Florida, Stati Uniti, 33770
        • The Heart Institute at Largo
    • Georgia
      • Columbus, Georgia, Stati Uniti, 31904
        • Columbus Regional Research Institute
    • Indiana
      • Anderson, Indiana, Stati Uniti, 46011
        • Community Clinical Research Center
    • Kansas
      • Overland Park, Kansas, Stati Uniti, 66209
        • Midwest Heart And Vascular Specialists, Llc.
    • Louisiana
      • Alexandria, Louisiana, Stati Uniti, 71301
        • Cambridge Medical Trials
    • Oklahoma
      • Tulsa, Oklahoma, Stati Uniti, 74136
        • Castlerock Clinical Research Consultants, Llc
    • Pennsylvania
      • Camp Hill, Pennsylvania, Stati Uniti, 17011
        • Capital Area Research, LLC
    • Tennessee
      • Tullahoma, Tennessee, Stati Uniti, 37388
        • Tennessee Center for Clinical Trials
    • Texas
      • Austin, Texas, Stati Uniti
        • Local Institution
      • Austin, Texas, Stati Uniti, 78705
        • Local Institution
    • Utah
      • Layton, Utah, Stati Uniti, 84041
        • Utah Cardiology P.C

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Arm A: Placebo (Matching with BMS-919373)
Placebo (Matching with BMS-919373) 0 mg tablets orally once daily for approximately 28 Days
Droga: Placebo (Matching with BMS-919373)
Sperimentale: Arm B: BMS-919373
BMS-919373 3 mg tablets orally once daily for approximately 28 days
Droga: BMS-919373
Sperimentale: Arm C: BMS-919373
BMS-919373 5 mg tablets orally once daily for approximately 28 days
Droga: BMS-919373
Sperimentale: Arm D: BMS-919373
BMS-919373 12 mg tablets orally once daily for approximately 28 days
Droga: BMS-919373

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percent Change From Baseline in Atrial Fibrillation Burden (AFB) as Assessed by SEEQ Mobile Cardiac Telemetry (MCT) System
Lasso di tempo: Day 8 to Day 29
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.
Day 8 to Day 29

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs and Death
Lasso di tempo: Up to Day 50
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.
Up to Day 50
Maximum Observed Concentarion (Cmax) of BMS-919373
Lasso di tempo: Day 1 and Day 22: Predose 1, 2, and 4 hours postdose
Cmax is defined as the maximum observed concentration of BMS-919373.
Day 1 and Day 22: Predose 1, 2, and 4 hours postdose
Trough Observed Concentration (Cmin) of BMS-919373
Lasso di tempo: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
Ctrough is defined as the minimum estimated plasma concentration at steady state.
Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
Oral Clearance (CL/F) of BMS-919373
Lasso di tempo: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
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.
Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
Central Volume of Distribution (Vc/F) of BMS-919373
Lasso di tempo: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
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.
Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
Absorption Rate Constant (Ka) of BMS-919373
Lasso di tempo: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
Ka is the absorption rate constant.
Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
Average Concentration (Cavg) of BMS-919373 at Steady State
Lasso di tempo: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
Cavg is defines as the average concentration at steady state.
Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
Area Under the Concentration-time Curve (AUC) at Steady State of BMS-919373
Lasso di tempo: Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
AUC is defined as the area under the concentration-time curve at steady state.
Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)
Time to First Atrial Fibrillation Recurrence (TTFR) (Symptomatic or Asymptomatic)
Lasso di tempo: Day 8 to Day 29
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.
Day 8 to Day 29
Total Number of Atrial Fibrillation Episodes
Lasso di tempo: Day 8 to Day 29
The total number AF episodes were derived from AF episode histogram data over the monitoring period.
Day 8 to Day 29
Average Duration of Atrial Fibrillation Per Episode
Lasso di tempo: Day 8 to Day 29
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.
Day 8 to Day 29

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Bristol-Myers Squibb

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

25 luglio 2014

Completamento primario (Effettivo)

1 giugno 2016

Completamento dello studio (Effettivo)

1 giugno 2016

Date di iscrizione allo studio

Primo inviato

12 maggio 2014

Primo inviato che soddisfa i criteri di controllo qualità

3 giugno 2014

Primo Inserito (Stima)

5 giugno 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

31 luglio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 luglio 2019

Ultimo verificato

1 luglio 2019

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CV205-005

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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