EUCTR2005-003976-39-DE进行中（未招募）不适用
An open-label, multicenter study to evaluate the efficacy and safety of a 5 week therapy with the combination of valsartan 160 mg plus amlodipine 10 mg in hypertensive patients not adequately responding to a 5 week therapy with ramipril 5 mg and felodipine 5 mg
ovartis Pharma GmbH0 个研究点目标入组 200 人开始时间: 2005年9月22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
- 200
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. Male or female patients >= 18 years
- •2. Patients with essential hypertension:
- •- At Visit 1, untreated patients (not having been treated with antihypertensive drugs in the month priot to V1) need to have a MSSBP >= 160 mmHg and < 180 mmHg and treated patients need to have a MSSBP < 180 mmHg. Untreated patients can be included as soon as the safety laboratory parameters are available, but not at the day of Visit 1. This inclusion visit will be recorded as Visit 3 in the CRF.
- •- At Visit 2, patients previously treated for hypertension need to have a MSSBP >= 160 mmHg and < 180 mmHg for entrance into the first treatment phase. Patients previously treated for hypertension who have a MSSBP < 160 mmHg at Visit 2 will continue the wash-out phase and will be again evaluated with regard to BP criteria at Visit 3. Untreated patients do not perform Visit 2.
- •- At Visit 3, which is not performed for patients who entered the first treatment phase already at Visit 2, patients need to have a MSSBP >= 160 mmHg and < 180 mmHg for entrance into the first treatment phase.
- •- At Visit 4, all patients need to have a MSSBP >= 140 mmHg for entrance into the second treatment phase
- •3. Written informed consent to participate in the study prior to any study procedures
- •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. MSSBP = 180 mmHg and/or MSDBP = 110 mmHg at any time between Visit 1 and Baseline
- •2. Inability to discontinue all antihypertensive medications safely for a period of up to two weeks prior to initiation of treatment
- •3. History of hypersensitivity to valsartan, ramipril, felodipine, amlodipine, inactive ingredients of these study drugs or to drugs with similar chemical structure, history of angioneurotic oedema
- •4. A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and peripheral artery disease
- •5. Known Keith-Wagener grade III or IV hypertensive retinopathy
- •6. Second or third degree heart block without a pacemaker, concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, clinically significant valvular heart disease
- •7. Heart failure NYHA II -IV
- •8. Evidence of a secondary form of hypertension, to include coarctation of the aorta, hyperaldosteronism, Cushing’s disease, unilateral or bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease
- •9. Diabetes mellitus type I or type 2 diabetes mellitus with poor glucose control as defined by persistent fasting blood glucose > 11 mmol/l or > 200 mg/dl at Visit 1.
- •10. Evidence of hepatic disease as determined by AST (SGOT) or ALT (SGPT) values > 2 x ULN at Visit 1
- •11. Known bilateral kidney artery stenosis or unilateral stenosis of the kidney artery if patient has only a single kidney
- •12. Patients after kidney transplantation
- •13. Known hypertrophic obstructive cardiomyopathy
- •14. Known primary hyperaldosteronism
- •15. A history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt
- •16. Evidence of renal impairment as determined by one of the followings: serum creatinine > 1.5 x ULN at Visit 1, a history of dialysis, or a history of nephrotic syndrome. If creatinine is found to be between 1.5 and 2 x UNL, a retest can be performed prior to initiation of treatment
- •17. Any severe, life-threatening disease within the past five years
- •18. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
- •19. Any surgical or medical condition which, at the discretion of the investigator, places the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period
- •20. History of drug or alcohol abuse within the last 2 years
- •21. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives before enrollment, whichever is longer
- •22. History of noncompliance with medical regimens, or patients unwilling to comply with the study protocol
- •23. Persons directly involved in the execution of this protocol/study
- •24. Inability to communicate and comply with all study requirements
- •25. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
- •26. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml).
- •27. Women of child-bearing potential (WOCBP), defined as all women physiolo
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