EUCTR2005-002382-36-DE进行中（未招募）不适用
A 12-week treatment, randomized, double-blind, parallel group, multicenter study to evaluate the efficacy of the valsartan/simvastatin combinations 160/20mg up titrated to 320/20mg versus 160/40mg up titrated to 320/40mg in patients with both essential hypertension and hypercholesterolemia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 796
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.Elevated LDL-C = 3.4mmol/l (130mg/dl) [or = 2.6mmol/l (100mg/dl) for diabetic patients] and < 4.9 mmol/l (190 mg/dl) and TG = 4mmol/l (350mg/dl) based on lab results of lipid profile drawn at Visit 3 for previously treated patients and at Visit 1 and 3 for previously untreated patients.
- •3.MSSBP = 140 mmHg (or = 130 mmHg for diabetic patients) and < 180 and/or MSDBP = 90 mmHg (or > 80 mmHg for diabetic patients) and < 110 mmHg at Visit 4 for previously treated patients and at Visit 1, 2, 3, and 4 for previously untreated patients.
- •4.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 = 180 mmHg and/or MSDBP = 110 mmHg at any time between Visit 1 and Visit 4
- •2.Inability to discontinue all prior lipid lowering and antihypertensive medications safely for a period of six and four weeks respectively prior to randomization
- •3.History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
- •4.Prior or known muscular or neuromuscular disease of any type
- •5.A history of cardiovascular disease, including angina, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and peripheral artery disease
- •6.Known Keith-Wagener grade III or IV hypertensive retinopathy
- •7.Second or third degree heart block without a pacemaker, concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, clinically significant valvular heart disease
- •8.Heart failure requiring treatment
- •9.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
- •10.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
- •11.Uncontrolled diabetes mellitus type 2, as defined by glycosylated hemoglobin HbA1c > 8% at Visit 1
- •12.Diabetic patients requiring insulin treatment
- •13.Evidence of hepatic disease as determined by AST (SGOT) or ALT (SGPT) values > 2 x ULN at Visit 1
- •14.A history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt
- •15.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 randomization
- •16.Serum creatine kinase (CK) levels > 2 x ULN at Visit 1. In case of doubt the test should be redone at the discretion of the investigator
- •17.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.
- •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.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been
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