Essential hypertension and hypercholesterolemia
Conditions
Interventions
Product Name: Valsartan
Pharmaceutical Form: Capsule*
INN or Proposed INN: Valsartan
CAS Number: 137862-53-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 160-
Ph
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion 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] 80 mmHg for diabetic patients) and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the combination of valsartan 160mg/simvastatin 40mg has superior efficacy compared to the combination of valsartan 160mg/simvastatin 20mg in the percentage change from baseline to week 6 in LDL-C;Primary end point(s): The primary efficacy variable is the percentage change from baseline in LDL-C to week 6. ;Secondary Objective: •To compare the effects of valsartan 160mg/simvastatin 20mg versus valsartan 160mg/simvastatin 40mg in reducing total cholesterol (TC), triglycerides (TG), non-high density lipoprotein cholesterol (non-HDL-C) and in increasing high density lipoprotein cholesterol (HDL-C) from baseline to week 6 •To compare the effects of valsartan 320mg/simvastatin 20mg titrated treatment versus valsartan 320mg/simvastatin 40mg titrated treatment in reducing LDL-C, TC, TG, non-HDL-C and in increasing HDL-C from baseline to week 12 •To estimate the percentage of patients who reach BP (BP <140/90 mmHg non-diabetic patients and < 130/80 mmHg diabetic patients) and/or LDL-C control at week 6 and 12 in each treatment group For detailed list see full protocol | — |
Countries
Germany, Sweden
Outcome results
None listed