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

Organon and Co0 sites786 target enrollmentMarch 2007

ConditionsHypercholesterolemia

Interventionsezetimibe (+) simvastatin

Drugsezetimibe (+) simvastatin Comparator: atorvastatin Comparator: rosuvastatin

Overview

Phase: Phase 3
Intervention: ezetimibe (+) simvastatin
Conditions: Hypercholesterolemia
Sponsor: Organon and Co
Enrollment: 786
Primary Endpoint: Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2007

End Date

June 2008

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Organon and Co

Responsible Party

Sponsor

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)

Arms & Interventions

1

Arm 1: Drug

Intervention: ezetimibe (+) simvastatin

Outcomes

Primary Outcomes

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.