A Double-Blind, Multicenter Study to Assess the LDL-C Lowering of Combination tablets Ezetimibe/Simvastatin (10mg/20mg) and Ezetimibe/Simvastatin (10mg/40mg) compared to Atorvastatin 20mg in Patients with Type II Diabetes. - Eze/Simva Switch Study in Diabetics
- Conditions
- Hypercholesterolemia in patients with Type II DiabetesMedDRA version: 7.0 Level: LLT Classification code 10020603
- Registration Number
- EUCTR2004-003000-37-BE
- Lead Sponsor
- Merck Sharp & Dohme BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 500
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
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 < 3 month, contact the Clinical Monitor for a case-by-case evaluation.)
e.Any condition or situation which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study.
PROHIBITED MEDICAL CONDITIONS:
f.Congestive heart failure defined by NYHA Class III or IV.
g.Myocardial infarction, coronary artery bypass surgery, or angioplasty within 3 months prior to Visit 1.
h.Uncontrolled hypertension (treated or untreated) with systolic blood pressure > 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 < 4 ?g/dL) at Visit 1. Note: Patient with a history of hypothyroidism, who is on stable therapy of thyroid hormone replacement for at least 6 weeks is eligible for enrollment if TSH level is within normal limits at screening Visit 1.
j.Impaired renal function [creatinine ? 177 ?mol/L (? 2.0 mg/dL)] or nephrotic syndrome at Visit 1.
k.Disorder of the hematologic, digestive, or central nervous systems including cerebrovascular disease and degenerative disease that would limit study evaluation or participation.
l.Patient who is known HIV positive.
m.Cancer within the past 5 years (except for successfully treated basal and squamous cell carcinoma).
n.History of mental instability, drug/alcohol abuse within the past 5 years, or major psychiatric illness not adequately controlled and stable on pharmacotherapy.
PROHIBITED CONCOMITANT THERAPIES:
o.Medications that are potent inhibitors of CYP3A4, including cyclosporin, systemic itraconazole or ketoconazole, erythromycin, telithromycin or clarithromycin, nefazodone, protease inhibitors. In addition, patients should not take amiodarone, verapamil, or danazol. Patient is consuming > 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the additional LDL-C lowering achieved by switching to Ezetimibe/Simvastatin compared to doubling the dose of Atorvastatin.;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.;Primary end point(s): 6 weeks of treatment for elevated cholesterol only
- Secondary Outcome Measures
Name Time Method