Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00462748 | A Study to Determine the Number of Patients Who Reach Optimal Cholesterol Levels on Each of Three Different Treatments (0653A-121) | PHASE3 | COMPLETED | 786 | — | — | Mar 1, 2007 | Jun 1, 2008 | May 16, 2024 | - | — |
| NCT00479713 | A Study to Assess the Cholesterol Lowering Effect of an Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Patients With High Cholesterol and With High Cardiovascular Risk (0653A-809)(COMPLETED) | PHASE3 | COMPLETED | 618 | — | — | Feb 1, 2007 | Mar 1, 2008 | May 16, 2024 | - | — |
| NCT00409773 | Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED) | PHASE3 | COMPLETED | 1,143 | — | — | Jan 1, 2007 | Jul 1, 2008 | May 16, 2024 | - | — |
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.
Percent Change in LDL-C at study endpoint after six weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure \*100.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Arm 1: Drug |
| 2 | ACTIVE_COMPARATOR | Arm 2: Active comparator |
| 3 | ACTIVE_COMPARATOR | Arm 3: Active comparator |
| 4 | OTHER | Arm 4: drug + comparator + Placebo |
| 5 | OTHER | Arm 5: drug + comparator + Placebo |
| Name | Type | Description |
|---|---|---|
| ezetimibe (+) simvastatin | DRUG | ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally, cholesterol lowering medication. |
| Comparator: atorvastatin | DRUG | atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally |
| Comparator: rosuvastatin | DRUG | rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally. |
| Comparator : rosuvastatin calcium | DRUG | rosuvastatin 10mg. The treatment duration will be 6 weeks. |
| Comparator: Placebo (unspecified) | DRUG | rosuvastatin 10mg Placebo. The treatment duration will be 6 weeks. |
| Comparator: atorvastatin calcium | DRUG | Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets. Each patient will receive 1 active treatment dose \& 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks. |
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 Sca...