A Study to Determine the Number of Patients Who Reach Optimal Cholesterol Levels on Each of Three Different Treatments.

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00462748
First received: April 18, 2007
Last updated: April 20, 2010
Last verified: April 2010

April 18, 2007
April 20, 2010
March 2007
June 2008   (final data collection date for primary outcome measure)
Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
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.
The percentage of patients achieving the target of <2mmol/L at study end
Complete list of historical versions of study NCT00462748 on ClinicalTrials.gov Archive Site
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A Study to Determine the Number of Patients Who Reach Optimal Cholesterol Levels on Each of Three Different Treatments.
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

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.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypercholesterolemia
  • Drug: ezetimibe (+) simvastatin
    ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally, cholesterol lowering medication.
    Other Name: MK0653A
  • Drug: Comparator: atorvastatin
    atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
    Other Name: atorvastatin
  • Drug: Comparator: rosuvastatin
    rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally.
    Other Name: rosuvastatin
  • Experimental: 1
    Arm 1: Drug
    Intervention: Drug: ezetimibe (+) simvastatin
  • Active Comparator: 2
    Arm 2: Active comparator
    Intervention: Drug: Comparator: atorvastatin
  • Active Comparator: 3
    Arm 3: Active comparator
    Intervention: Drug: Comparator: rosuvastatin
McCormack T, Harvey P, Gaunt R, Allgar V, Chipperfield R, Robinson P; IN-PRACTICE study. Incremental cholesterol reduction with ezetimibe/simvastatin, atorvastatin and rosuvastatin in UK General Practice (IN-PRACTICE): randomised controlled trial of achievement of Joint British Societies (JBS-2) cholesterol targets. Int J Clin Pract. 2010 Jul;64(8):1052-61. Epub 2010 May 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
786
June 2008
June 2008   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00462748
2007_013, MK0653A-121
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP