A Study to Determine the Number of Patients Who Reach Optimal Cholesterol Levels on Each of Three Different Treatments (0653A-121)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00462748
Recruitment Status : Completed
First Posted : April 19, 2007
Results First Posted : August 17, 2009
Last Update Posted : April 14, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
To evaluate the percentage of patients with either established cardiovascular 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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: ezetimibe (+) simvastatin Drug: Comparator: atorvastatin Drug: Comparator: rosuvastatin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 786 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A MC, DB, Rand, Study to Evaluate Efficacy, Safety and Tolerability of Eze/Simva 10/40 mg, Atorva 40 mg, Rosuva 10 mg in Achieving LDL-C <2 mmol/l in Pts With CVD...on Simva 40 mg With LDL-C ³2 mmol/l
Study Start Date : March 2007
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Arm 1: Drug
Drug: ezetimibe (+) simvastatin
ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally, cholesterol lowering medication.
Other Name: MK0653A
Active Comparator: 2
Arm 2: Active comparator
Drug: Comparator: atorvastatin
atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
Other Name: atorvastatin
Active Comparator: 3
Arm 3: Active comparator
Drug: Comparator: rosuvastatin
rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally.
Other Name: rosuvastatin

Primary Outcome Measures :
  1. Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End [ Time Frame: 6 Weeks ]
    Fasting LDL-C was the primary efficacy variable. The primary efficacy analysis was based on the proportion of patients achieving a target of <2mmol/l in fasting LDL-C at study end.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00462748

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00462748     History of Changes
Other Study ID Numbers: 0653A-121
First Posted: April 19, 2007    Key Record Dates
Results First Posted: August 17, 2009
Last Update Posted: April 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors