Status:
COMPLETED
A Study to Determine the Number of Patients Who Reach Optimal Cholesterol Levels on Each of Three Different Treatments (0653A-121)
Lead Sponsor:
Organon and Co
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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/...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
786 Patients enrolled
Trial Details
Trial ID
NCT00462748
Start Date
March 1 2007
End Date
June 1 2008
Last Update
May 16 2024
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