EUCTR2005-001256-20-HU进行中（未招募）不适用
A randomized, double blind, double dummy, parallel group,placebo controlled study to evaluate the pharmacodynamic andpharmacokinetic response and safety and tolerability ofSB424323 (250 mg, 375 mg and 500 mg) administered twicedaily for 16 weeks, on top of aspirin (325 mg, qd) in men andwomen with non valvular atrial fibrillation at a low orintermediate risk for stroke
GlaxoSmithKline Research and Development Ltd.0 个研究点目标入组 640 人开始时间: 2005年9月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 640
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
- •A subject will be eligible for inclusion in this study only if all of the following criteria
- •1. Male or female =18 years of age at the time informed consent is signed.
- •2. Women must be surgically sterile or postmenopausal (greater than 1 year since their
- •last menstrual period with an FSH level of greater than 30 IMU/ml). Surgically sterile is defined as a total hysterectomy or bilateral oopherectomy. A tubal ligation
- •is not acceptable as surgically sterile.
- •3. Diagnosis of chronic non valvular atrial fibrillation with a low or intermediate risk
- •for stroke within 6 months of the screening visit confirmed by either ECG or
- •Subjects diagnosed with paroxysmal AF, persistent AF or permanent AF are
- •all eligible for participation in the study. Subjects with atrial flutter do not
- •qualify for the study.
- •Subjects previously diagnosed with hyperthyroidism, with normal thyroid
- •function and continued AF are eligible for participation in the study.
- •A subject will be considered at a low or intermediate risk for stroke if one of the
- •following applies:
- •Subjects =60 years of age with no heart disease
- •Subjects <60 years of age with heart disease but no risk factors (defined as:
- •heart failure, left ventricular ejection fraction less than 35%, diabetes, history of
- •hypertension and prior embolic event)
- •Subjects =60 yrs and =75 years of age with no risk factors and no heart disease
- •4. Is available for participation in the study for at least 20 weeks.
- •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
- •A subject will not be eligible for inclusion in this study if any of the following criteria
- •1. Previous myocardial infarction, stroke (ischemic or hemorrhagic), TIA or other
- •cardiovascular event
- •2. Subjects with mechanical prosthetic valve or rheumatic valvular disease
- •3. History of hypertension (defined as medical treatment for the disease within the past
- •year), diabetes (defined as medical treatment for the disease within the past year) or
- •prior embolic event
- •4. Subjects with a LVEF less than 35%
- •5. Subjects that are greater than 75 years of age at the screening visit or subjects that
- •will become greater than 75 years of age during their participation in the study.
- •6. Subjects with hepatic disease as defined by any ALT, AST or bilirubin abnormality
- •at the screening visit.
- •7. Subjects with chronic liver disease (e.g. Hepatitis C)
- •8. Renal insufficiency as defined by creatinine clearance less than 30 ml/min
- •9. Subjects requiring treatment with Class III anti-arrhythmic drugs
- •10. Subjects with an ongoing requirement for any anti-thrombotic drug therapy such as a
- •vitamin K antagonist, heparin (standard unfractionated or low molecular weight), heparinoid, direct thrombin inhibitor, GPIIb/IIIA receptor antagonist, thrombolytic
- •agent or intravenous dextran.
- •11. Subject requires ongoing treatment with clopidogrel.
- •12. Subject requires ongoing treatment with amiodarone or dofetilide.
- •13. Subject requires ongoing treatment with a calcium channel blocker.
- •14. History of aspirin sensitivity or any contraindication to aspirin
- •15. History of gastrointestinal bleed or gastrointestinal intolerance when taking aspirin
- •16. Subjects with a history of hypercoagulable syndrome or vasculitis
- •17. Subjects with conditions that subject them to an increased risk of bleeding such as:
- •Previous gastrointestinal bleeding
- •Hemorrhagic disorders
- •History of intraocular, spinal, intracranial, retroperitoneal bleeding
- •Major surgical procedure or major hemorrhagic event within 30 days prior to
- •screening visit
- •18. Subjects with anemia as defined by hemoglobin <12 g/dL.
- •19. NVAF secondary to other reversible disorders such as thyrotoxicosis.
- •20. Malignancy within the past five years [other than superficial squamous cell
- •carcinoma which is non-invasive on pathology, basal cell carcinoma which is
- •successfully treated with local excision, and/or cervical cancer in situ treated
- •definitively at least 6 months prior to screening].
- •21. Life expectancy less than 1 year
- •22. Has any concurrent medical condition or any clinically significant abnormality
- •identified on the screening physical examination, laboratory tests or
- •electrocardiogram, which otherwise contraindicates participation in a clinical trial
- •with a new chemical entity.
- •23. Has a history of alcohol abuse, substance abuse or both, within the past year, as
- •determined by the investigator.
- •24. Use of any investigational drug or device within 30 days or 5 half lives (whichever is
- •longer) prior to screening.
- •25. There is a known hypersensitivity to any drugs chemically related to the
- •investigational product.
- •26. In the opinion of the Investigator, has a risk of non-compliance with study
- •procedures, cannot read, and cannot understand study-related materials.
研究者
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