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

NCT ID: NCT00462748

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 786 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2008-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Arm 1: Drug

Group Type: EXPERIMENTAL

ezetimibe (+) simvastatin

Intervention Type: DRUG

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

2

Arm 2: Active comparator

Group Type: ACTIVE_COMPARATOR

Comparator: atorvastatin

Intervention Type: DRUG

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

3

Arm 3: Active comparator

Group Type: ACTIVE_COMPARATOR

Comparator: rosuvastatin

Intervention Type: DRUG

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

Interventions

ezetimibe (+) simvastatin

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

Intervention Type: DRUG

Comparator: atorvastatin

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

Intervention Type: DRUG

Comparator: rosuvastatin

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

Intervention Type: DRUG

Other Intervention Names

MK0653A; atorvastatin; rosuvastatin

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: DERIVED

PMID: 20487050 (View on PubMed)

Other Identifiers

MK0653A-121

Identifier Type: -

Identifier Source: secondary_id

2007_013

Identifier Type: -

Identifier Source: secondary_id

0653A-121

Identifier Type: -

Identifier Source: org_study_id