| Primary | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 | Participants had LDL-C levels assessed at baseline and after 12 weeks of study drug administration. The change from baseline was calculated. | All participants who received at least 1 dose of study treatment, and had a baseline observation or at least 1 post-baseline observation. One participant who received misallocated study medication during placebo run-in period was excluded from the main population for the analysis of efficacy data. | Posted | | Least Squares Mean | 95% Confidence Interval | Percentage Change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | 1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks. | | OG001 | Atorvastatin 10 mg | 1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks. | | OG002 | Atorvastatin 20 mg | 2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks. | | OG003 | Ezetimibe 10 mg + Atorvastatin 10 mg | 1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks | | OG004 | Ezetimibe 10 mg + Atorvastatin 20 mg | 1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks |
| | Units | Counts |
|---|
| Participants | - OG00035
- OG00168
- OG00268
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-19.3(-22.7 to -15.8)
- OG001-44.0(-46.5 to -41.6)
- OG002-49.1(-51.5 to -46.7)
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Constrained longitudinal data analysis | | <0.001 | | Difference in Least Squares Means | -36.3 | | | 2-Sided | 95 | -40.5 | -32.2 | | | | | Superiority or Other (legacy) | | | | | Constrained longitudinal data analysis | |
|
| Primary | Percentage of Participants Who Experience 1 or More Gastrointestinal-related Adverse Events (AEs) | Gastrointestinal-related AEs included all preferred terms within system organ class of Gastrointestinal Disorders except Chapped Lips and Toothache. | All randomized participants who received at least 1 dose of actual study treatment. | Posted | | Number | | Percentage of Participants | | up to 14 weeks | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | 1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks. | | OG001 | Atorvastatin 10 mg | 1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks. | | OG002 | Atorvastatin 20 mg | 2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks. | | OG003 | Ezetimibe 10 mg + Atorvastatin 10 mg | 1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks |
|
| Primary | Percentage of Participants Who Experience 1 or More Gallbladder-related AEs | Gallbladder-related AEs included Bile Duct Obstruction, Bile Duct Stone, Bile Duct Stenosis, Biliary Colic, Cholangitis, Cholecystectomy, Cholecystitis, Cholelithiasis, Gallbladder Disorder, Gallbladder Perforation, Hepatic Pain, and Hydrocholecystis. | All randomized participants who received at least 1 dose of actual study treatment. | Posted | | Number | | Percentage of Participants | | up to 14 weeks | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | 1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks. | | OG001 | Atorvastatin 10 mg | 1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks. | | OG002 | Atorvastatin 20 mg | 2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks. | | OG003 | Ezetimibe 10 mg + Atorvastatin 10 mg | |
|
| Primary | Percentage of Participants Who Experience 1 or More Allergic Reaction or Rash AEs | Allergic Reaction or Rash AEs included Allergy to Arthropod Sting, Anaphylactoid Reaction, Anaphylactic Reaction, Anaphylatic Shock, Anaphylactoid Shock, Angioedema, Conjunctivitis Allergic, Contrast Media Reaction, Dermatitis, Dermatitis Allergic, Dermatitis Atopic, Dermatitis Bullous, Dermatitis Contact, Dermatitis Psoriasiform, Drug Hypersensitivity, Eczema, Eosinophila, Erythema, Eye Allergy, Face Oedema, Hypersensitivity, Mechanical Urticaria, Palmar Erythema, Periorbital Oedema, Photodermatosis, Photosensitivity Allergic reaction, Photosensitivity Reaction, Pigmentation Disorder, Pruritus, Pruritus Generalised, Rash, Rash Erythematous, Rash Follicular, Rash Generalised, Rash Maculo-Papular, Rash Papulosquamous, Rash Pruritic, Rash Pustular, Rash Vesicular, Rhinitis, Rhinitis Allergic, Rosacea, Skin Exfoliation, Skin Disorder, Skin Hyperpigmentation, Skin Lesion, Skin Mass, Skin Ulcer, Subcutaneous Nodule, Swelling Face, Systemic Lupus Erythematosus Rash, Urticaria. | All randomized participants who received at least 1 dose of actual study treatment. | Posted | | Number | | Percentage of Participants | | up to 14 weeks | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | 1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks. | | OG001 | Atorvastatin 10 mg | 1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks. |
|
| Primary | Percentage of Participants Who Experience 1 or More Hepatitis-related AEs | Hepatitis-related AEs included Cholestasis, Cytolytic Hepatitis, Hepatic Cyst, Hepatic Failure, Hepatic Lesion, Hepatic Necrosis, Hepatitis, Hepatitis Cholestatic, Hepatitis Fulminant, Hepatitis Infectious, Hepatocellular Injury, Hepatomegaly, Jaundice, Jaundice Cholestatic. | All randomized participants who received at least 1 dose of actual study treatment. | Posted | | Number | | Percentage of Participants | | up to 14 weeks | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | 1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks. | | OG001 | Atorvastatin 10 mg | 1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks. | | OG002 | Atorvastatin 20 mg | 2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks. | | OG003 | Ezetimibe 10 mg + Atorvastatin 10 mg | |
|
| Primary | Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) ≥3 Times Upper Limit of Normal (ULN) | Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT that were 3 x ULN or greater were recorded. The ALT ULN was 40 U/L. | All randomized participants who received at least 1 dose of actual study treatment. | Posted | | Number | | Percentage of Participants | | up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | 1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks. | | OG001 | Atorvastatin 10 mg | 1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks. | | OG002 | Atorvastatin 20 mg | 2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks. | | OG003 | Ezetimibe 10 mg + Atorvastatin 10 mg | |
|
| Primary | Percentage of Participants Who Experience Consecutive Elevations in Aspartate Aminotransferase (AST) ≥3 Times ULN | Participants had AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of AST that were 3 x ULN or greater were recorded. The AST ULN was 40 U/L. | All randomized participants who received at least 1 dose of actual study treatment. | Posted | | Number | | Percentage of Participants | | up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | 1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks. | | OG001 | Atorvastatin 10 mg | 1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks. | | OG002 | Atorvastatin 20 mg | 2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks. | | OG003 | Ezetimibe 10 mg + Atorvastatin 10 mg | 1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks |
|
| Primary | Percentage of Participants Who Experience Consecutive Elevations in ALT and/or AST ≥3 Times ULN | Participants had ALT and AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 3 x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L. | All randomized participants who received at least 1 dose of actual study treatment. | Posted | | Number | | Percentage of Participants | | up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | 1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks. | | OG001 | Atorvastatin 10 mg | 1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks. | | OG002 | Atorvastatin 20 mg | 2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks. | | OG003 | Ezetimibe 10 mg + Atorvastatin 10 mg | |
|
| Primary | Percentage of Participants Who Experience Consecutive Elevations in ALT ≥5 Times ULN | Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had an assessment of ALT that was 5x ULN or greater were recorded. The ALT ULN was 40 U/L. | All randomized participants who received at least 1 dose of actual study treatment. | Posted | | Number | | Percentage of Participants | | up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | 1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks. | | OG001 | Atorvastatin 10 mg | 1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks. | | OG002 | Atorvastatin 20 mg | 2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks. | | OG003 | Ezetimibe 10 mg + Atorvastatin 10 mg | 1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks |
|
| Primary | Percentage of Participants Who Experience Consecutive Elevations in AST ≥5 Times ULN | Participants had AST levels assessed throughout the 12 week treatment period. Participants who had an assessment of AST that was 5x ULN or greater were recorded. AST ULN was 40 U/L. | All randomized participants who received at least 1 dose of actual study treatment. | Posted | | Number | | Percentage of Participants | | up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | 1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks. | | OG001 | Atorvastatin 10 mg | 1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks. | | OG002 | Atorvastatin 20 mg | 2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks. | | OG003 | Ezetimibe 10 mg + Atorvastatin 10 mg | 1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks |
|
| Primary | Percentage of Participants Who Have Consecutive Elevations in ALT and/or AST ≥5 Times ULN | Participants had ALT and AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 5 x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L. | All randomized participants who received at least 1 dose of actual study treatment. | Posted | | Number | | Percentage of Participants | | up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | 1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks. | | OG001 | Atorvastatin 10 mg | 1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks. | | OG002 | Atorvastatin 20 mg | 2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks. | | OG003 | Ezetimibe 10 mg + Atorvastatin 10 mg | |
|
| Primary | Percentage of Participants Who Experience Consecutive Elevations in ALT ≥10 Times ULN | Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had an assessment of ALT that was 10x ULN or greater were recorded. The ALT ULN was 40 U/L. | All randomized participants who received at least 1 dose of actual study treatment. | Posted | | Number | | Percentage of Participants | | up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | 1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks. | | OG001 | Atorvastatin 10 mg | 1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks. | | OG002 | Atorvastatin 20 mg | 2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks. | | OG003 | Ezetimibe 10 mg + Atorvastatin 10 mg | 1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks |
|
| Primary | Percentage of Participants Who Experience Consecutive Elevations in AST ≥10 Times ULN | Participants had AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of AST that were 10x ULN or greater were recorded. The AST ULN was 40 U/L. | All randomized participants who received at least 1 dose of actual study treatment. | Posted | | Number | | Percentage of Participants | | up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | 1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks. | | OG001 | Atorvastatin 10 mg | 1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks. | | OG002 | Atorvastatin 20 mg | 2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks. | | OG003 | Ezetimibe 10 mg + Atorvastatin 10 mg | 1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks |
|
| Primary | Percentage of Participants Who Have Consecutive Elevations in ALT and/or AST ≥10 Times ULN | Participants had ALT and AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 10x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L. | All randomized participants who received at least 1 dose of actual study treatment. | Posted | | Number | | Percentage of Participants | | up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | 1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks. | | OG001 | Atorvastatin 10 mg | 1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks. | | OG002 | Atorvastatin 20 mg | 2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks. | | OG003 | Ezetimibe 10 mg + Atorvastatin 10 mg | |
|
| Primary | Percentage of Participants With Potential Hy's Law Condition | Percentage of Participants with Potential Hy's Law Condition (defined as serum ALT or serum AST elevations >3xULN, with serum alkaline phosphatase <2xULN and total bilirubin (TBL) ≥2xULN) was summarized. The ALT and AST ULNs were 40 U/L. The ULN for alkaline phosphatase was 359 IU/L and the ULN for total bilirubin was 1.2 mg/dL. | All randomized participants who received at least 1 dose of actual study treatment. | Posted | | Number | | Percentage of Participants | | up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | 1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks. | | OG001 | Atorvastatin 10 mg | 1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks. | | OG002 | Atorvastatin 20 mg | 2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks. | | OG003 | Ezetimibe 10 mg + Atorvastatin 10 mg |
|
| Primary | Percentage of Participants Who Have Elevations in Creatine Kinase (CK) ≥10xULN | Participants had creatine phosphokinase (CK) levels assessed throughout the 12 week treatment period. Participants who had any CK level that was ≥10 x ULN were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively. | All randomized participants who received at least 1 dose of actual study treatment. | Posted | | Number | | Percentage of Participants | | up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | 1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks. | | OG001 | Atorvastatin 10 mg | 1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks. | | OG002 | Atorvastatin 20 mg | 2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks. | | OG003 | Ezetimibe 10 mg + Atorvastatin 10 mg | |
|
| Primary | Percentage of Participants Who Have Elevations in CK ≥10xULN With Muscle Symptoms | Participants had CK levels assessed throughout the 12 week treatment period. Participants who had any CK level that was ≥10 x ULN and had associated muscle symptoms present within +/- 7 days were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively. | All randomized participants who received at least 1 dose of actual study treatment. | Posted | | Number | | Percentage of Participants | | up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | 1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks. | | OG001 | Atorvastatin 10 mg | 1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks. | | OG002 | Atorvastatin 20 mg | 2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks. | | OG003 | Ezetimibe 10 mg + Atorvastatin 10 mg | |
|
| Primary | Percentage of Participants Who Have Elevations in CK ≥10xULN and Drug-Related Muscle Symptoms | Participants had CK levels assessed throughout the 12 week treatment period. Participants who had any CK level that was ≥10 x ULN and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly-related to study drug were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively. | All randomized participants who received at least 1 dose of actual study treatment. | Posted | | Number | | Percentage of Participants | | up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Ezetimibe 10 mg | 1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks. | | OG001 | Atorvastatin 10 mg | 1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks. | | OG002 | Atorvastatin 20 mg | 2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks. | | OG003 | Ezetimibe 10 mg + Atorvastatin 10 mg |
|