Hypercholesterolemia in patients with Type II Diabetes MedDRA version: 7.0 Level: LLT Classification code 10020603
Conditions
Interventions
Trade Name: INEGY
Product Name: INEGY
Product Code: MK0653a
Pharmaceutical Form: Tablet
INN or Proposed INN: Ezetimibe/Simvastatin
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Patient is currently treated with atorvastatin 10 mg for at least 6 weeks. b. Patient has Diabetes Mellitus, Type II. c. Patient has HbA1C of less than or equal to 10.0%. d. Patient having liver transaminases (ALT, AST) less than or equal to 50% above the upper limit of normal at Visit 1, with no active liver disease, and/or creatine kinase (CK) less than or equal to 50% above the upper limit of normal. 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
Exclusion criteria: a. Female patient receiving hormone therapy not on a stable dose and regimen for at least 8 weeks prior to Visit 1 or is unwilling to continue the same regimen throughout the study. b. Patients with alcohol consumption > 14 drink per week. (A drink is: a can of beer, glass of wine, or single measure of spirits.) c. Patients who are pregnant or lactating. d. Patients who have been treated with any other investigational drug within 3 months of Visit 1. (If 160 mm Hg or diastolic > 100 mm Hg at Visit 1. i. Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins (i.e. secondary causes of hyperlipidemia) or secondary hypercholesterolemia due to hypothyroidism, (T4 1 quart of grapefruit juice/day. p. Lipid-lowering agents including fish oils, Cholestin, bile-acid sequestrants, other HMG-CoA reductase inhibitors, and niacin (>200 mg/day) taken within 6 weeks and fibrates within 8 weeks prior to randomization at Visit 2 (Day 1). q. Oral corticosteroids (unless used as replacement therapy for pituitary/adrenal disease and on a stable regimen for at least 6 weeks prior to Visit 1). r. Patient is not stable on cardiovascular medications, such as beta-blockers, calcium-channel blockers, ACE inhibitors, nitrates, a-adrenergic blockers, thiazide diuretics or anticoagulants (i.e. warfarin), or psyllium, other fiber-based laxatives, and/or an OTC therapy known to affect serum lipid (phytosterol margarine) for at least 6-weeks. Note: Patient will be eligible to participate if on a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the additional LDL-C lowering achieved by switching to Ezetimibe/Simvastatin compared to doubling the dose of Atorvastatin.;Primary end point(s): 6 weeks of treatment for elevated cholesterol only;Secondary Objective: To determine the effect of Ezetimibe/Simvastatin (10mg/40mg, 10mg/20mg) compared to Atorvastatin 20mg on total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, LDL-C/HDL-C ratio, TC/HDL-C ratio and apolipoprotein (apo) B. (2) To further evaluate safety of Ezetimibe/Simvastatin (10mg/40mg, 10mg/20mg) compared to Atorvastatin 20mg. | — |
Countries
Belgium, Germany, Italy, Lithuania, Spain
Outcome results
None listed