Phase 3
N=786
A Study to Determine the Number of Patients Who Reach Optimal Cholesterol Levels on Each of Three Different Treatments (0653A-121)
Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT00462748 ↗Enrolled (actual)
786
Serious AEs
—
Results posted
Aug 2009
Primary outcome: Primary: Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End — 67.4; 36.3; 17.4 Percent — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ezetimibe (+) simvastatin (Drug); Comparator: atorvastatin (Drug); Comparator: rosuvastatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End |
67.4; 36.3; 17.4 | <0.001 sig |
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.
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 3xuln)
- Patient Is Pregnant, Lactating, Or A Female Patient Of Childbearing Potential Not Using Adequate Contraception
- Patient Has Severe Renal Impairment: Creatinine Clearance 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)
Data sourced from ClinicalTrials.gov (NCT00462748). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.