A Randomized, Double-Blind, Active-Controlled, MulticenterStudy of Patients with Primary Hypercholesterolemia and HighCardiovascular Risk and not Adequately Controlled with Atorvastatin20 mg: A Comparison of Switching to a Combination TabletEzetimibe/Simvastatin (10mg/40mg) versus Doubling the BaselineDose to Atorvastatin 40 mg

• Conditions: Primary hypercholesterolemia; MedDRA version: 9.1Level: LLTClassification code 10020604Term: Hypercholesterolemia

• Registration Number: EUCTR2008-005002-40-HU
• Lead Sponsor: Merck & Co. Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

* ATP III High Risk patients
* >=18 and <80 years of age with primary hypercholesterolemia.
* Either statin/ezetimibe naïve or on an acceptable stable dose, and willing to maintain a cholesterol-lowering diet for the duration of the study.
* Baseline LDL-C must be between = 100 mg/dL (2.59 mmol/L) and = 160 mg/dL (4.14 mmol/L), TG = 350 mg/dL (3.96 mmol/L), ALT/AST = 2.0 X ULN, and CK = 3.0 X ULN.
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

Patient is :
* hypersensitive/intolerant to any component of the study medication,
* has CHF NYHA Class III or IV,
* an uncontrolled hypertensive or diabetic, or is actively trying to lose weight.
* has estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2
based on the 4-variable MDRD (Modification of Diet in Renal Disease) equation
at Visit 1 (as done by the central lab), nephrotic syndrome or other clinically
significant renal disease at Visit 1 (Week -6).
* has uncontrolled endocrine or metabolic disease known to influence serum
lipids or lipoproteins (i.e., secondary causes of hyperlipidemia, e.g. hyper or
hypothyroidism, Cushing’s syndrome) at Visit 1 (Week -6).
* has uncontrolled cardiac arrhythmias or recent significant changes in the
patient’s electrocardiogram (ECG).
Prohibited medications include:
* CYP3A4 inhibitors,
* lipid-lowering agents,
* systemic corticosteroids,
* anti-obesity medications,
* warfarin, or medications that could increase the risk of myopathy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified