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

NCT00462748 | Completed Phase 3 Results

• 3 other identifiers: 0653A-121MK0653A-1212007_013
• Study Type: interventional
• Target: 786
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End

  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.

  6 Weeks

Study Arms (3)

1

EXPERIMENTAL

Arm 1: Drug

Drug: ezetimibe (+) simvastatin

2

ACTIVE COMPARATOR

Arm 2: Active comparator

Drug: Comparator: atorvastatin

3

ACTIVE COMPARATOR

Arm 3: Active comparator

Drug: Comparator: rosuvastatin

Interventions

ezetimibe (+) simvastatin DRUG

ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally, cholesterol lowering medication.

Also known as: MK0653A

1

Comparator: atorvastatin DRUG

atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally

Also known as: atorvastatin

2

Comparator: rosuvastatin DRUG

rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally.

Also known as: rosuvastatin

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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. doi: 10.1111/j.1742-1241.2010.02429.x. Epub 2010 May 12.

  PMID: 20487050 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Ezetimibe, Simvastatin Drug Combination; Atorvastatin; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Simvastatin; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ezetimibe; Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Sulfur Compounds; Pyrimidines

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2007
• First Posted: April 19, 2007
• Study Start: March 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: May 16, 2024
• Results First Posted: August 17, 2009

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share