EUCTR2005-003958-94-DE进行中（未招募）不适用
A randomized, open-label, multicenter, cross-over trial to evaluate the efficacy of a 20 week treatment of Valsartan 320 mg (Diovan) versus Atenolol 100 mg in combination with Hydrochlorothiazide on microcirculation in hypertensive patients - DIVINATIO
ovartis Phama GmbH0 个研究点目标入组 34 人开始时间: 2005年9月29日最近更新:
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
- 34
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
- •1. Caucasian; male or female outpatients and age between 40-65 years of age, inclusive.
- •2. Diagnosed at Visit 1 to be mild-to-moderate hypertensive with a MSDBP =95 mm Hg and < 110 mm Hg for non treated patients. Previously treated patients should have a MSDBP <110 mmHg at Visit 1. Treated is defined as having taken medication until = 2 days prior to Visit 1.
- •3. At Visit 2 all patients must have a MSDBP = 90 mmHg and < 110 mmHg.
- •4. Written informed consent to participate in the study prior to any study procedures.
- •5. Ability to communicate and comply with all study requirements.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.If a single reading for arterial hypertension in MSSBP > 180 mm Hg or MSDBP of > 110 mm Hg at any visit after randomization.
- •2. Inability to discontinue all prior antihypertensive medications safely for a period of 2 weeks prior to randomization.
- •3. Known history of hypotensive symptoms or orthostatic hypotension.
- •4. Concomitant use of statins or statin intake during the four weeks prior to Visit 1.
- •5. Known or suspected contraindications as listed in the basic prescribing information, including history of hypersensitivity to any of the study drugs (valsartan, atenolol and HCTZ) or to drugs with similar chemical structures or to inactive ingredients of valsartan film-coated tablets, atenolol or hydrochlorothiazide tablets.
- •6. Known Keith-Wagener grade III or IV hypertensive retinopathy.
- •7. Concurrent life threatening arrhythmia or symptomatic arrhythmia.
- •8. History of secondary form of hypertension, such as coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing’s disease, pheochromocytoma, polycystic kidney disease, etc..
- •9. A history of stroke, transient ischemic cerebral attack, hypertensive encephalopathy, coronary artery bypass surgery, percutaneous transluminal angioplasty or myocardial infarction anytime prior to visit 1.
- •10. A history of heart failure (NYHA II-IV).
- •11. Second or third degree heart block, sick sinus syndrome or sinuatrial block.
- •12. Bradycardia at Visit 1, defined as < 50 beats per minute.
- •13. Acidosis.
- •15. Hypovolaemia
- •16. History of bronchial hypersensitivity e.g. asthma bronchiale.
- •17. Any form of clinically significant peripheral circulatory disturbances.
- •18. Clinically significant valvular heart disease.
- •19. Concomitant unstable angina pectoris
- •20. Evidence of renal impairment as determined by one of the following: Serum creatinine clearance < 30 ml/min as determined by Cockroft and Gault formula [Cockroft and Gault, 1976], serum creatinine > 1.5 mg/dL at Visit 1, a history of dialysis, history of nephritic syndrome, acute glomerulonephritis, kidney donor or kidney recipient.
- •21. Insulin dependent Diabetes mellitus.
- •22. Uncontrolled treated Type 2 Diabetes mellitus with poor glucose control defined as HbA1c > 7.0 % at Visit 1.
- •23. Evidence of hepatic disease or cholestasis as determined by any one of the following: ALT (SGPT) or AST (SGOT) values >2 x upper limit of normal (ULN) at Visit 1, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt.
- •24. Gout or known history of recurrent clinical significant hyperuricaemia
- •25. Serum potassium <3.5 mmol/l or >5.5 mmol/l at Visit 1.
- •26. Serum sodium < 132mmol/L or > 150 mmol/L at Visit 1.
- •27. Hypercalcaemia >2.7 mmol/l.
- •Further exclusion criteria are defined in the study protocol.
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