A Pilot Phase II, Randomised, Double-blind, Placebo-controlled, Multi-centred Safety, Tolerability and Preliminary EfficacyStudy of RSD1235-SR for the Prevention of Atrial Fibrillation/Atrial Flutter (AF/AFL) Recurrence in Subjects Post-Conversion from AF

Cardiome Pharma Corp.0 个研究点目标入组 0 人开始时间: 2005年12月8日最近更新: 2021年8月2日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Cardiome Pharma Corp.

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•To participate in the study subjects must:
•- Comprehend and sign a written informed consent form, (including at US sites, HIPAA Authorisation; and at European sites, per EU Privacy Directive as implemented by member states in national law, as applicable);
•- Be over 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 submission 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;
•- Have adequate anticoagulant therapy in accordance with standard of practice as recommended by ACC/AHA/ESC guidelines (Fuster V. et al.,2001);
•- Be haemodynamically stable (100mmHg < systolic blood pressure < 190mmHg) 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)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

排除标准

•To participate in this study a subject may not:
•- Have known prolonged QT syndrome or uncorrected QT interval of >0.460 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 >0.14 sec;
•- Documented previous episodes of second or third-degree atrioventricular block;
•- Have known bradycardia, sick-sinus syndrome or pacemaker;
•- Have significant valvular stenosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis;
•- Have Class III or Class IV congestive heart failure at screening or admission, or have been hospitalised for heart failure in the previous 6 months;
•- Have unstable angina;
•- Have a myocardial infection (MI) or acute coronary syndrome within 30 days prior to entry into the study;
•- 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 secondary causes of AF such as alcohol intoxication, pulmonary embolism, hyperthyroidism, pneumonia, hypoxemia (oxygen saturation < 90% on room air), acute pericarditis, cardiac surgery, or myocarditis;
•- Have previous thromboembolic disease (i.e. stroke);
•- Potassium (K+) <3.5 mmol/L (<3.5 mEq/L) or >5.5 mmol/L (>5.5 mEq/L) or Magnesium (Mg²+) below the lower limit of normal (<1.3 mEq/L). (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 solalol) within 3 days of randomization 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 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.

研究者

发起方

Cardiome Pharma Corp.

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