Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Atorvastatin 10mg, Comparator: atorvastatin
Atorvastatin · 7 trials · 2 indications
Serum LDL-C calculated using Friedewald formula at baseline and after 6 weeks of treatment in each of the 2 treatment periods.
\[(6 week value - baseline value)/baseline value\]\*100%.
Percent Change in LDL-C = \[(week 6 value - baseline value)/baseline value\]\*100%
The percentage of participants achieving the target low-density-lipoprotein cholesterol (LDL-C) levels (≤100 mg/dL \[2.59 mmol/L\]) as determined from blood samples following a standard ultracentrifugation/precipitation procedure (β-quantification).
An adverse event (AE) is defined as any physical or clinical change or disease reported by a participant or observed by the investigator or member of the staff at any time during the study, regardless of potential relationship to study treatment, and included onset or discovery of new illness and exacerbation of any pre-existing condition.
An adverse event (AE) is defined as any physical or clinical change or disease reported by a participant or observed by the investigator or member of the staff at any time during the study, regardless of potential relationship to study treatment, and included onset or discovery of new illness and exacerbation of any pre-existing condition.
| Arm | Type | Description |
|---|---|---|
| Ezetimibe and atorvastatin | ACTIVE_COMPARATOR | Medication will be administered in a double dummy fashion as 3 tablets orally on a daily basis, including 10 mg ezetimibe, 20 mg atorvastatin, and placebo to ezetimibe/atorvastatin. |
| Ezetimibe/atorvastatin combination | EXPERIMENTAL | Medication will be administered in a double dummy fashion as 3 tablets orally on a daily basis, including ezetimibe/atorvastatin 10 mg/20 mg, placebo to ezetimibe, and placebo to atorvastatin. |
| 1 | EXPERIMENTAL | Each patient will receive 1 active treatment dose \& 2 Placebo (Pbo) doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. |
| 2 | EXPERIMENTAL | Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. |
| 3 | EXPERIMENTAL | Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. |
| 4 | EXPERIMENTAL | Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. |
| 5 | EXPERIMENTAL | Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. |
| Atorvastatin 80 mg | EXPERIMENTAL | 80 mg atorvastatin taken orally, once daily for 12 weeks |
| Ezetimibe + Atorvastatin 40 mg | EXPERIMENTAL | 10 mg ezetimibe and 40 mg atorvastatin taken orally, once daily for 12 weeks |
| Ezetimibe + Atorvastatin 80 mg | EXPERIMENTAL | 10 mg ezetimibe and 80 mg atorvastatin taken orally, once daily for 12 weeks |
| Simvastatin 80 mg | EXPERIMENTAL | 80 mg simvastatin taken orally, once daily for 12 weeks |
| Ezetimibe + Simvastatin 40 mg | EXPERIMENTAL | 10 mg ezetimibe and 40 mg simvastatin taken orally, once daily for 12 weeks |
| Ezetimibe + Simvastatin 80 mg | EXPERIMENTAL | 10 mg ezetimibe and 80 mg simvastatin taken orally, once daily for 12 weeks |
| Atorvastatin Monotherapy | EXPERIMENTAL | Participants receive double-blind atorvastatin 10 mg once daily (QD) via oral tablet PLUS open-label atorvastatin 10 mg QD via oral tablet for the entire duration of the study. Double-blind atorvastatin is to be added to the regimen for participants not achieving LDL-C target (≤100 mg/dL; 2.59 mmol/L). The maximum possible total daily dose of atorvastatin received in this group is 80 mg (10 mg open label plus 70 mg double blind). |
| Ezetimibe + Atorvastatin | EXPERIMENTAL | Participants receive double-blind ezetimibe 10 mg QD via oral tablet PLUS open-label atorvastatin 10 mg QD via oral tablet for the entire duration of the study. Double-blind atorvastatin is to be added to the regimen for participants not achieving LDL-C target (≤100 mg/dL; 2.59 mmol/L). The maximum possible total daily dose of atorvastatin received in this group is 40 mg (10 mg open label plus 30 mg double blind). |
| Name | Type | Description |
|---|---|---|
| Atorvastatin | DRUG | 20 mg tablet administered orally once daily |
| Ezetimibe | DRUG | 10 mg tablet administered orally once daily |
| Ezetimibe/atorvastatin | DRUG | Ezetimibe/atorvastatin 10 mg/20 mg combination tablet administered orally once daily |
| Placebo to atorvastatin | DRUG | Administered orally once daily |
| Placebo to ezetimibe | DRUG | Administered orally once daily |
| Placebo to ezetimibe/atorvastatin | DRUG | Administered orally once daily |
| Atorvastatin 10 mg | DRUG | Atorvastatin 10 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks |
| Ezetimibe 10 mg/simvastatin 20 mg | DRUG | Ezetimibe 10 mg/simvastatin 20 mg and Placebo for atorvastatin once daily for 12 weeks |
| Atorvastatin 20 mg | DRUG | Atorvastatin 20 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks |
| Ezetimibe 10 mg/simvastatin 40 mg | DRUG | Ezetimibe 10 mg/simvastatin 40 mg and Placebo for atorvastatin once daily for 12 weeks |
| Atorvastatin 40 mg | DRUG | Atorvastatin 40 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks |
| Comparator: atorvastatin | DRUG | Atorvastatin 40mg tablet po qd (by mouth, once a day) for 6 weeks |
| Comparator: Placebo | DRUG | Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day). for 6 weeks |
| Comparator: ezetimibe | DRUG | Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day). for 6 weeks. |
| Comparator: Placebo. | DRUG | Atorvastatin 40mg Pbo tablets po qd (by mouth, once a day). for 6 weeks. |
| Simvastatin | DRUG | Tablets taken orally once daily in the morning or evening |
| Placebo for Ezetimibe | DRUG | Tablets taken orally once daily in the morning or evening |
| Placebo for Atorvastatin | DRUG | Single placebo tablet administered orally QD |
Inclusion criteria: * At low, moderate, or moderately high cardiovascular risk (according to National Cholesterol Education Program adult treatment panel III \[NCEP ATP III\] guidelines) and either statin-naïve with LDL-C ≥130 mg/dL for low risk or ≥100 mg/dL for moderate or moderately high risk OR...