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

ovartis Pharma Services AG0 sites796 target enrollmentSeptember 27, 2005

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 27, 2005

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ovartis Pharma Services AG

Eligibility Criteria

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