Clinical Trials List
2010-08-30 - 2012-11-30
Phase III
Terminated16
ICD-10I48.0
Paroxysmal atrial fibrillation
ICD-10I48.2
Chronic atrial fibrillation
ICD-10I48.91
Unspecified atrial fibrillation
ICD-9427.31
Atrial fibrillation
A Phase III, Prospective, Randomized, Double-Blind, PlaceboControlled Multicenter Study to Evaluate the Efficacy and Safety of MK-6621 in Patients with Atrial Fibrillation
-
Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
-
Sponsor
MERCK SHARP & DOHME (I.A.) LLC. TAIWAN BRANCH (U.S.A.)
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Li-Wei Lo Division of Cardiovascular Diseases
- 胡瑜峰 Division of Cardiovascular Diseases
- 顏鴻章 Division of Emergency Medicine
- Shih-Lin Chang Division of Cardiovascular Diseases
- Yenn-Jiang Lin Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 吳茲睿 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Ju-Yi Chen Division of Cardiovascular Diseases
- Cheng-Han Lee Division of Cardiovascular Diseases
- Po-Sheng Chen Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 陳建仁 Division of Cardiovascular Diseases
- 鄭正一 Division of Cardiovascular Diseases
- 郭必芳 Division of Cardiovascular Diseases
- 陳永隆 Division of Cardiovascular Diseases
- 方志元 Division of Cardiovascular Diseases
- 蔡子賢 Division of Cardiovascular Diseases
- 楊正旭 Division of Cardiovascular Diseases
- 吳炯仁 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 劉言彬 Division of Cardiovascular Diseases
- WEI-TIEN CHANG Division of Emergency Medicine
- CHIA-TI TSAI Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 許志雄 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Yung-Kuo Lin Division of Cardiovascular Diseases
- Yi-Jen Chen Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Proportion of patients with
treatment-induced conversion of
AF to sinus rhythm (for a
minimum duration of 1 minute)
within the 90-minute period after
first exposure to study drug
Secondary:
1.Time to conversion of AF to sinus
rhythm (for a minimum duration
of 1 minute) within the 24-hour
period after first infusion..
2. Number of symptoms associated
with AF at 90 minutes after first
infusion.
3.Maintenance of sinus rhythm at 24
hours
4.Maintenance of sinus rhythm at 7
days
Inclution Criteria
2. Patient understands the study procedures and risks involved with the study,
and voluntarily agrees to participate by giving written informed consent.
3. Patient who is of reproductive potential agrees to remain abstinent or use (or
have their partner use) 2 acceptable methods of birth control from time of screening
until 30-day follow-up. Acceptable methods of birth control are: intrauterine
device (IUD), diaphragm with spermicide, contraceptive sponge, condom,
vasectomy, hormonal contraception.
Note: If non-cyclical oral hormonal contraception is used as one of the methods,
non-cyclical hormonal contraceptives must have been used for at least 2 months
prior to randomization for patients to be eligible for entry to the study.
A female patient who is not of reproductive potential is eligible without requiring
the use of contraception. A female patient who is not of reproductive potential is
defined as: one who has either 1) reached natural menopause defined as age 46
or older with a minimum of 12 months spontaneous amenorrhea, or 2) a minimum
of 6 weeks post surgical bilateral oophorectomy or hysterectomy, or 3) bilateral
tubal ligation.
4. Patient has an atrial arrhythmia with dysrhythmic symptoms that has been
sustained for greater than 3 hours and up to 7 days.
5. Patient has atrial fibrillation (in which the atrial activity is either absent or
chaotic both in amplitude and in rate) on the Screening ECG.
6. Patient is receiving adequate anticoagulant therapy as defined by the clinical
practice of the Investigator. If the PI believes that the patient does not need
anticoagulant therapy, that is acceptable.
7. Patient is hemodynamically stable at screening (100 mm Hg < systolic blood
pressure < 160 mm Hg and diastolic blood pressure < 95 mm Hg at screening and
continuously through to baseline). There should be no evidence of hemodynamic
instability over the 12 hours prior to screening. Blood pressures will be measured
3 times after resting supine for 3 minutes and averaged to determine a baseline BP.
8. Patient has a body weight between 45 and 136 kg (99 and 300 lbs). For
patients weighing >113 kg (250 lbs), dose should be based on a weight of 113 kg
(250 lbs) and not higher.
9. Patient is adequately hydrated (in the investigator’s opinion) and has an intravenous
line (IV) established and infusing maintenance fluids through a venous port which
will not be used for study drug administration.
Exclusion Criteria
1. Patient is currently participating in another drug study or has received an investigational drug
within 30 days prior to enrollment, or has previously received MK-6621.
2. Patient is pregnant (positive serum β-HCG) or breast-feeding, or expecting to conceive from
time of screening until 30-day follow-up.
3. Patient routinely consumes more than 2 alcoholic drinks per day (average >14 alcoholic drinks
per week).
4. Patient has any condition or situation which, in the opinion of the investigator, might pose a risk
to the patient or interfere with participation in the study.
Prohibited Medical Conditions
5. Patient has known or suspected prolonged QT, familial long QT syndrome, previous Torsades
de Pointes, Brugada syndrome.
6. Patient has complex ventricular ectopy (i.e., idioventricular rhythm, accelerated idioventricular
rhythm, sustained or unsustained ventricular tachycardia, ventricular fibrillation, Torsades de
pointes, ventricular flutter, or frequent polymorphic premature ventricular complexes) on any
ECG or on heart monitoring during screening or at baseline.
7. Patient has known bradycardia, advanced AV block, or sick-sinus syndrome, unless controlled
by a pacemaker.
8. Patient has severe aortic stenosis.
9. Patient has a QRS > 140 msec unless patient has pacemaker.
10. Patient has an uncorrected QT > 440 msec as measured on a 12-lead ECG.
11. Patient has a ventricular rate less than 50 bpm as documented by a 12-lead ECG.
12. Patient has atrial flutter
13. Patient has Class IV congestive heart failure (CHF) or heart failure requiring intravenous
inotrope therapy.
14. Patient has had a myocardial infarction (MI) or acute coronary syndrome (ACS), or cardiac
surgery within 30 days prior to entry into the study.
15. Patient has troponin (I or T) levels above the upper limit of normal.
16. Patient has known atrial thrombus.
17. Patient has reversible causes of AF such as alcohol intoxication, hyperthyroidism, acute
pericarditis and pulmonary embolism.
18. Patient has serious pulmonary, hepatic, metabolic, renal, gastrointestinal, CNS or psychiatric
disease, infection, febrile illness (temperature above 38.5o
C), end stage disease states, or any
other disease that could interfere with the conduct or validity of the study or compromise patient
safety.
19. Patient has uncorrected electrolyte imbalance.
Note: Patients with serum potassium levels that are less than 3.5 mEq/L (3.5mM) or greater
than 5.5 mEq/L (5.5 mM) or serum magnesium levels below the lower limit of normal are
allowed entry provided that the electrolytes be corrected prior to dosing.
20. Patient has clinical evidence of digoxin toxicity
21. Patient has failed electrical cardioversion during current episode of AF.
22. Patient has received intravenous Class I or Class III antiarrhythmic drugs or intravenous
amiodarone within 7 days prior to dosing.
23. Patient has received any oral Class I or Class III antiarrhythmic drugs for the purpose of
conversion of atrial fibrillation to sinus rhythm within 7 days prior to dosing.
Note: Oral antiarrhythmic drugs for the purpose of maintenance therapy are
allowed, provided they are withheld from screening until 2 hours post-study drug.
24. Patient has a history of malignancy ≤ 2 years prior to signing informed consent, except for
adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer (melanoma,
leukemia, lymphoma and myeloproliferative disorders of any duration are excluded).
25. Patient has a history of mental instability, drug/alcohol abuse within the past 5 years, or major
psychiatric illness not adequately controlled and stable on pharmacotherapy.
Prohibited Concomitant Therapies
26. Patient may not receive a loading dose or bolus supplementation of rate control drugs such as
β-adrenergic blocking agents, calcium antagonists or digoxin within 2 hours of screening.
27. Patient may not receive any investigational drug from 30 days prior to enrollment, until 30 days
following randomization.
The Estimated Number of Participants
-
Taiwan
65 participants
-
Global
615 participants
