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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 796

Inclusion Criteria

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] < 4.9 mmol/l (190mg/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

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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