EUCTR2005-003606-28-DE进行中（未招募）不适用
A 12 week treatment, open-label, multicenter study to investigate the efficacy and safety of valsartan 160-320 mg with regard to effects on lipid subfractions in hypertensive patients with metabolic syndrome
ovartis Pharma GmbH0 个研究点目标入组 75 人开始时间: 2005年11月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
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 outpatients = 18 years of age at Visit 1
- •2. MSSBP = 140 mmHg and < 170 and/or MSDBP = 90 mmHg and < 105 mmHg at Visit 2 for previously treated patients and at Visit 1 and 2 for previously untreated patients.
- •3. Fasting triglycerides greater than or equal to 150 mg/dL (1.69 mmol/L) at V1
- •4. Metabolic syndrome as defined by ATP III (involving one or more of the following) at Visit 1 (high triglycerides and elevated BP are mandatory in this trial):
- •Central/abdominal obesity as measured by waist circumference (Men > 102 cm; Women > 88 cm)
- •HDL cholesterol [Men < 40 mg/dL (1.04 mmol/L); Women < 50 mg/ dL (1.29 mmol/L)]
- •Fasting glucose greater than or equal to 110 mg/dL (6.1 mmol/L)
- •5. Written informed consent to participate in this 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 = 170 mmHg and/or MSDBP = 105 mmHg at any time between Visit 1 and Visit 2
- •2. Fasting plasma glucose = 126 mg/dl at Visit 1
- •3. Fasting LDL cholesterol = 160 mg/dl, fasting triglycerides = 600 mg/dl at Visit 1
- •4. Inability to discontinue all antihypertensive medications safely for a period of three weeks prior to initiation of treatment
- •5. Patients treated with lipid lowering drugs in the last 6 weeks prior to Visit 1, use of probucol in the last 6 months prior to V1
- •6. History of hypersensitivity to valsartan, inactive ingredients of valsartan capsules or to drugs with similar chemical structures
- •7. 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
- •8. Known Keith-Wagener grade III or IV hypertensive retinopathy
- •9. Second or third degree heart block without a pacemaker, concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, clinically significant valvular heart disease
- •10. Heart failure NYHA II -IV
- •11. 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
- •12. Evidence of hypercholesterolemia secondary to other causes. This includes, but is not restricted to: alcoholism, auto-immune disease, nephrotic syndrome, any viral or non-viral hepatitis clinically active within 12 months prior to Visit 1, obstructive hepatic or biliary disease, dys- or macroglobulinemia, multiple myeloma, glycogen storage disease, uncontrolled hypothyroidism or hyperthyroidism, chronic pancreatitis and porphyria
- •13. Diabetes mellitus type I or II
- •14. Major depression requiring pharmacolgical treatment
- •15. Evidence of hepatic disease as determined by AST (SGOT) or ALT (SGPT) values > 3 x ULN at Visit 1
- •16. A history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt
- •17. 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
- •18. Any severe, life-threatening disease within the past five years
- •19. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug including but not limited to any of the following:
- •- History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection, gastric bypass, gastric stapling, or gastric banding
- •- Currently active or active inflammatory bowel disease during the 12 months prior to Visit 1
- •- Currently active gastritis, ulcers, or gastrointestinal/rectal bleeding or urinary tract obstruction regarded as clinically meaningful by the investigator
- •20. 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
- •21. History of drug or alcohol abuse within the last 2 years
- •22. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives before enrollment, whicheve
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