Official Title: “A MC, DB, Rand, Study to Evaluate Efficacy, Safety and Tolerability of Eze/Simva 10/40mg, Atorva 40mg, Rosuva 10mg in Achieving LDL-C <2mmol/l in Pts With CVD...on Simva 40mg With LDL-C ³2 Mmol/l”

To evaluate the percentage of patients with either established CVD, at "high risk" of developing CVD or with diabetes who are on simvastatin 40mg, with fasting LDL-C &gt;2mmol/l, who are able to attain the recommended LDL-C target of &lt;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 10 mg. 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 July 02, 2009

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