EUCTR2004-000186-35-HU进行中（未招募）不适用
A randomized, double blind, active controlled, parallel group study to evaluate the effectiveness of valsartan 320 mg in combination with lisinopril 20 mg versus monotherapy with lisinopril 40 mg or valsartan 320 mg in hypertensive patients with microalbuminuria on reduction of urinary albumin creatinine ratio. - Valeria
ovartis Pharma GmbH0 个研究点目标入组 150 人开始时间: 2005年2月9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
- 150
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
- •Male or female subjects, age between 18-75 years inclusive.
- •Patients with mild to moderate hypertension with a MSDBP >= 85 and < 110 mm Hg for non treated patients. Previously treated patients with MSDBP < 110 mm Hg. Treated is defined as having taken medication until < 2 days prior to Visit 1
- •Positive urine spot test with Micral dipstick (detection of urinary albumin concentration >= 20 mg/l) at Visit 1 (day -21).
- •Written informed consent to participate in the study prior to any study procedures.
- •Confirmation of MAU determined in the first morning urine samples performed at Visit 2 (day -14) and Visit 3 (day -7). MAU is defined for male patients as UACR >= 2.5 mg/mmol and <= 25.0 mg/mmol and for female patients as UACR >= 3.5 mg/mmol and <= 35.0 mg/mmol at both visits.
- •At Visit 4 all patients with mild to moderate hypertension with a MSDBP >= 85 mm Hg and < 110 mm Hg.
- •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
- •1. Any kind of kidney disease, which is not primarily caused by diabetes or hypertension.
- •2. Any clinically relevant abnormality in kidney ultrasound, in the urine sediment or urine analysis with dipstick at Visit 1 (decision for exclusion due to clinically relevant abnormalities for protein, glucose and pH measured via dipstick is at discretion of the investigator).
- •3. Evidence of renal impairment as determined by any one of the following: Serum creatinine clearance < 30 ml/min as determined by Cockroft and Gault and/or serum creatinine > 1.25 x ULN at Visit 1, a history of dialysis, or a history of nephrotic syndrome.
- •4. Serum potassium values <3.5 mmol/l or >5.5 mmol/l at Visit 1
- •5. Any medical condition which might significantly alter the urinary excretion of albumin
- •6. Fluid depletion; the patient is to be instructed to drink at least 2 l/day, especially during the last day prior Visit 1-4, 9 and 12.
- •7. Unwillingness or inability to avoid extensive exercise (any sport activity lasting longer than 30 minutes) during the last day prior Visit 1-4, 9 and 12.
- •8. Active urinary infection
- •9. Vaginal discharge/fluor and/or vaginal infection
- •10. Active systemic infection and/or fever
- •11. Current obstruction of the urinary tract or difficulty in voiding due to mechanical as well as inflammatory conditions which is likely to require intervention during the course of the study or is regarded as clinically meaningful by the investigator
- •12. Severe hypertension defined as grade 3 of WHO classification; mean sitting diastolic blood pressure MSDBP >=110 mm Hg and/or mean sitting systolic blood pressure (MSSBP) >=180 mm Hg
- •13. Known history of hypotensive symptoms or orthostatic hypotension
- •14. Type 1 Diabetes mellitus
- •15. Uncontrolled treated Type 2 Diabetes mellitus with poor glucose control defined as HbA1c > 8.0 % at Visit 1
- •16. Inability to discontinue all prior anti-hypertensive medications safely for a period of 3 weeks, as required by the protocol
- •17. Administration of any agent indicated for the treatment of hypertension after the visit 1, permitted exception of those anti-hypertensive medications requiring tapering down commencing at Visit 1
- •18. Mandatory indication for any concomitant medication for coronary artery disease or any other disease that is not allowed during this study
- •19. Known or suspected contraindications as listed in the basic prescribing information, including history of allergy to ARBs and ACEIs, incl. consideration on contraindications of free add-on medication amlodipine and HCTZ
- •20. History of hypertensive encephalopathy, coronary artery bypass surgery, percutaneous transluminal angioplasty, transient ischemic cerebral attack, stroke or myocardial infarction during the last 12 months prior to Visit 1
- •21. Known Keith-Wagener grade III or IV hypertensive retinopathy
- •22. Evidence of a secondary form of hypertension, to include coarctation of the aorta, hyperaldosteronism, renal artery stenosis, or pheochromocytoma
- •23. History of heart failure
- •24. Second or third degree heart block without a pacemaker
- •25. Concomitant unstable angina pectoris
- •26. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia
- •27. Clinically significant valvular heart disease
- •28. Evidence of hepatic disease or cholestasis as determined by any one of the following: ALT or AST values 2 x ULN at visit 1, a history of hepatic encephalopathy, a history of esophageal varices, or a history of a portocaval shunt
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