NCT00526136已完成2 期
Vernakalant (Oral) Prevention of Atrial Fibrillation Recurrence Post-Conversion Study
Advanz Pharma152 个研究点 分布在 9 个国家目标入组 735 人开始时间: 2007年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 735
- 试验地点
- 152
- 主要终点
- Time to first documented recurrence of symptomatic sustained AF.
研究概览
简要总结
To evaluate the safety, tolerability and efficacy of 3 doses of vernakalant (oral) (150 mg, 300 mg and 500 mg b.i.d.) administered for up to 90 days in subjects with sustained symptomatic atrial fibrillation (AF duration > 72 hours and < 6 months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Comprehend and sign a written informed consent form, (per local and national regulations, as applicable)
- •Be 18 to 85 years of age
- •Women must not be pregnant, be non-nursing and if pre-menopausal, must be using an effective form of birth control from time of screening until 3 months after the last dose of medication. Methods of birth control considered to be effective may include hormonal contraception (the pill), an intrauterine device (IUD), condoms in combination with a spermicidal cream, total abstinence or sterilisation. Men should be advised not to conceive a child and are advised to use an effective form of birth control from admission until 3 months after the last dose of study medication
- •Have symptomatic AF that has been sustained for greater than 72 hours and less than 6 months duration and is clinically indicated for cardioversion;
- •Have adequate anticoagulant therapy for cardioversion in accordance with standard of practice as recommended by ACC/AHA/ESC guidelines (Fuster V. et al, 2006);
- •Be haemodynamically stable (100 mmHg < systolic blood pressure < 190 mmHg) at screening and on Day 1 before dosing (while taking rate control drugs, if required). After resting supine for 3 minutes, blood pressures should be measured 3 times in 5 minutes with at least 1 minute between assessments;
- •Have a body weight between 45 and 113 kg (99 and 250 lbs).
排除标准
- •Have known prolonged QT syndrome or QTcB interval of >0.500 sec as measured at screening on a 12 lead ECG; familial long QT syndrome; previous Torsades de Pointes; ventricular fibrillation; or sustained ventricular tachycardia (VT).
- •Have a QRS >0.140 sec;
- •Documented previous episodes of second or third-degree atrioventricular block;
- •Have clinically significant persistent bradycardia with ventricular rate below 50 beats/min, sick-sinus syndrome or pacemaker;
- •Have clinically significant moderate or severe aortic valvular stenosis (gradient >25 mmHg), hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis;
- •Have Class III or Class IV congestive heart failure at screening or admission, or have been hospitalized for heart failure in the previous 6 months;
- •Have a myocardial infarction (MI), cardiac surgery, angioplasty, unstable angina or acute coronary syndrome within 30 days prior to entry into the study; h) Have serious pulmonary, hepatic, metabolic, renal (serum creatinine > 2.0 mg/dl), gastrointestinal, central nervous system (CNS) or psychiatric disease, end-stage disease states, or any other disease that could interfere with the conduct or validity of the study or compromise subject safety;
- •Have known concurrent temporary secondary causes of AF such as alcohol intoxication, pulmonary embolism, hyperthyroidism, pneumonia, hypoxemia (oxygen saturation < 90% on room air), acute pericarditis, or myocarditis;
- •Potassium (K+) <3.5 mmol/L or >5.5 mmol/L or magnesium (Mg2+) below the lower limit of normal (Mg2+< 0.65 mmol/L in subjects 65 years or younger and <0.80 mmol/L in subjects 66 years or older). (Both K+ and Mg2+ should be corrected prior to dosing);
- •Have clinical evidence of digoxin toxicity;
- •Have received an oral Class I or Class III antiarrhythmic agent (including sotalol) within 3 days of randomisation or oral amiodarone within 4 weeks, or have received intravenous Class I or Class III antiarrhythmic agent or i.v. amiodarone within 24 hours prior to start of dosing;
- •Have any other surgical or medical condition that, in the judgment of the clinical Investigator might warrant exclusion or be contraindicated for safety reasons;
- •Be concurrently participating in another drug study or have received an investigational drug within 30 days prior to screening;
- •Be unable to communicate well with the Investigator and to comply with the requirements of the entire study;
研究组 & 干预措施
1
Placebo Comparator
Placebo (b.i.d.)
干预措施: Placebo (Drug)
2
Experimental
Vernakalant (oral), 150 mg (b.i.d.)
干预措施: Vernakalant (oral) (Drug)
3
Experimental
Vernakalant (oral), 300 mg (b.i.d.)
干预措施: Vernakalant (oral) (Drug)
4
Experimental
Vernakalant (oral), 500 mg (b.i.d.)
干预措施: Vernakalant (oral) (Drug)
结局指标
主要结局
Time to first documented recurrence of symptomatic sustained AF.
时间窗: Time to first documented recurrence of symptomatic sustained AF within Day 90 of dosing
Safety assessments- Vital signs, safety laboratory assays, ECG parameters, physical examinations, and frequency of adverse events
时间窗: Safety assessments within Day 120 of dosing
次要结局
- Time to first documented recurrence of symptomatic or asymptomatic sustained AF(Time to first documented recurrence of symptomatic or asymptomatic sustained AF within 90 days of dosing)
- Time to first documented recurrence of symptomatic AF(Time to first documented recurrence of symptomatic AF within 90 days of dosing)
- Time to first documented recurrence of symptomatic or asymptomatic AF(Time to first documented recurrence of symptomatic or asymptomatic AF within 90 days of dosing)
- Proportion of subjects in sinus rhythm on Day 90.(Proportion of subjects in sinus rhythm on Day 90 of dosing)
- Improvement in AF symptoms as assessed by an AF symptom checklist.(Improvement in AF symptoms as assessed by an AF symptom checklist within Day 90 of dosing)
- Improvement in QOL as measured by SF-36(Improvement in QOL as measured by SF-36 within Day 90 of dosing)
研究者
研究点 (152)
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