Official Title: “A Multicentre, Double-Blind, Randomised, Parallel-Group Study to Evaluate the Efficacy, Safety and Tolerability of Ezetimibe/Simvastatin 10/40mg, Atorvastatin 40mg, and Rosuvastatin 10mg to Achieve an LDL-C Level of <2mmol/l in Patients With Established CVD or at "High Risk" of Developing CVD, Currently Treated With Simvastatin 40mg and With a Fasting LDL-C 2 Mmol/l”

To evaluate the percentage of patients with either established Cardio Vascular Disease (CVD), at "high risk" of developing CVD or with diabetes who are on simvastatin 40mg, with fasting LDL-C >2mmol/L, who are able to attain the recommended LDL-C target of <2mmol/L following 6 weeks treatment with either ezetimibe/simvastatin 10/40mg, atorvastatin 40mg or rosuvastatin 10mg.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2008

Intervention(s) in this Clinical Trial

• Drug: ezetimibe (+) simvastatin
  • ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, All tablet form, taken orally, cholesterol lowering medication.
• Drug: Comparator: atorvastatin
  • atorvastatin 40mg. once daily tablet formulation, All tablet form, taken orally.
• Drug: Comparator: rosuvastatin
  • rosuvastatin 10mg. once daily tablet formulation, All tablet form, taken orally.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Arm 1: Drug
• Active Comparator: 2
  • Arm 2: Active comparator
• Active Comparator: 3
  • Arm 3: Active comparator

Primary Measures

• The percentage of patients achieving the target of <2mmol/L at study end
  • Time Frame: 6 Weeks
    Safety Issue?: No

Inclusion Criteria:

• Patient is male or female and aged over 18
• Patient provides written informed consent
• Patient has a fasting ldl-c level >2mmol/l at both visit 1 and again at visit 2
• Patient has established cvd, diabetes or at "high risk" of cvd (>20 % risk over 10 years, framingham scale)
• Patient has taken simvastatin 40mg continuously for the past 6 weeks
• Patient has a fasting triglyceride level of <3.7mmol/l
• Patient has hba1c <9% at visit 1
• Patient is 75% compliant with medication between visit 1 and visit 2

Exclusion Criteria:

• Patient is hypersensitive to any of the study medications or their components
• Patient has a history of, or active liver disease (persistent elevation of alt / ast (>3xuln)
• Patient is pregnant, lactating, or a female patient of childbearing potential not using adequate contraception
• Patient has severe renal impairment: creatinine clearance <30ml/min (Cockcroft-Gault equation) (in patients with moderate renal impairment: <60ml/min, the dose of rosuvastatin will be 5mg in line with the spc)
• Patient has uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins (i.e. secondary causes of hyperlipidaemia such as hypothyroidism or hyperthyroidism)
• Patient has a recent history of, or current, alcohol abuse
• Patient has ck >10 x uln at visit 1 or visit 2
• Patient has fasting ldl-c >4.2mmol/l
• Patient has any acute or serious condition, or history suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g.
• sepsis, hypotension, major surgery, trauma, severe metabolic, severe endocrine and electrolyte disorders or uncontrolled seizures)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00462748

Study ID Number: 2007_013

ClinicalTrials.gov Identifier: NCT00462748

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

(MedWatch - FDA maintained medical product safety Information)

(PhRMA Clinical Study Results Database - web-based repository for clinical study results)

(Merck: Patient & Caregiver U.S. Product Web Site)