- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02156076
A Blinded Study to Evaluate Effect on Atrial Fibrillation Burden in Patients With Paroxysmal Atrial Fibrillation
2019년 7월 29일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
158
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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Anaheim, California, 미국, 92801
- Oracle Clinical Research, Inc.
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Anaheim, California, 미국, 92801
- Cardiology Consultants Of Orange County Med. Group Inc
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Costa Mesa, California, 미국, 92626
- WCCT Global, LLC
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Long Beach, California, 미국, 90822
- Long Beach VA Medical Center
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Moreno Valley, California, 미국, 92553
- Spectrum Clinical Research
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Connecticut
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Waterbury, Connecticut, 미국, 06708
- Chase Medical Research, LLC
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Florida
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Cooper City, Florida, 미국, 33024
- ALL Medical Research, LLC
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Gainesville, Florida, 미국, 32605
- The Cardiac And Vascular Institute Research Foundation, Llc
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Lake Worth, Florida, 미국, 33462
- Acrc Cardiology
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Largo, Florida, 미국, 33770
- The Heart Institute at Largo
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Georgia
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Columbus, Georgia, 미국, 31904
- Columbus Regional Research Institute
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Indiana
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Anderson, Indiana, 미국, 46011
- Community Clinical Research Center
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Kansas
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Overland Park, Kansas, 미국, 66209
- Midwest Heart And Vascular Specialists, Llc.
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Louisiana
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Alexandria, Louisiana, 미국, 71301
- Cambridge Medical Trials
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Oklahoma
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Tulsa, Oklahoma, 미국, 74136
- Castlerock Clinical Research Consultants, Llc
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Pennsylvania
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Camp Hill, Pennsylvania, 미국, 17011
- Capital Area Research, LLC
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Tennessee
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Tullahoma, Tennessee, 미국, 37388
- Tennessee Center For Clinical Trials
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Texas
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Austin, Texas, 미국
- Local Institution
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Austin, Texas, 미국, 78705
- Local Institution
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Utah
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Layton, Utah, 미국, 84041
- Utah Cardiology P.C
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Quebec, 캐나다, G1V 4G5
- Local Institution
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Alberta
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Edmonton, Alberta, 캐나다, T6G 2B7
- Local Institution
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British Columbia
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New Westminster, British Columbia, 캐나다, V3L 3W4
- Fraser Clinical Trials Inc.
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Ontario
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Cambridge, Ontario, 캐나다, N1R 7R1
- Local Institution
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Grimsby, Ontario, 캐나다, L3M 1P3
- Dr. Andy S.C. Lam Medicine Professional
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London, Ontario, 캐나다, N6G 2V4
- Stroke Prevention & Artherosclerosis Research Centre
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Newmarket, Ontario, 캐나다
- Local Institution
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Oshawa, Ontario, 캐나다, L1J 2J9
- Local Institution
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Oshawa, Ontario, 캐나다, L1J 2K1
- King Street Cardiology
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Toronto, Ontario, 캐나다, M3M 3E5
- Local Institution
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Waterloo, Ontario, 캐나다, N2T 0C1
- Local Institution
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Quebec
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Greenfield Park, Quebec, 캐나다, J4V 2G8
- Viacar Recherche Clinique
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Montreal, Quebec, 캐나다, H1T 1C8
- Local Institution
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Montreal, Quebec, 캐나다, H2W 1T8
- Local Institution
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Terrebonne, Quebec, 캐나다, J6V 2H2
- Csss Du Sud De Lanaudiere-Hopital Pierre-Le Gardeur
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: 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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실험적: Arm B: BMS-919373
BMS-919373 3 mg tablets orally once daily for approximately 28 days
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실험적: Arm C: BMS-919373
BMS-919373 5 mg tablets orally once daily for approximately 28 days
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실험적: Arm D: BMS-919373
BMS-919373 12 mg tablets orally once daily for approximately 28 days
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percent Change From Baseline in Atrial Fibrillation Burden (AFB) as Assessed by SEEQ Mobile Cardiac Telemetry (MCT) System
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs and Death
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2014년 7월 25일
기본 완료 (실제)
2016년 6월 1일
연구 완료 (실제)
2016년 6월 1일
연구 등록 날짜
최초 제출
2014년 5월 12일
QC 기준을 충족하는 최초 제출
2014년 6월 3일
처음 게시됨 (추정)
2014년 6월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 7월 31일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 7월 29일
마지막으로 확인됨
2019년 7월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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Bristol-Myers Squibb완전한
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