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

Phase 3

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: ezetimibe (+) simvastatin

• Registration Number: NCT00462748
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-04-18
• Study First Submitted QC: 2007-04-18
• Study First Posted: 2007-04-19
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2009-05-07
• Results First Submitted QC: 2009-07-06
• Results First Posted: 2009-08-17
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 786

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ezetimibe (+) simvastatin	Arm 1: Drug

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End	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.