Trial Outcomes & Findings for A Study of the Efficacy and Safety of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-832) (NCT NCT02741245)
NCT ID: NCT02741245
Last Updated: 2024-05-16
Results Overview
Participants had LDL-C levels assessed at baseline and after 12 weeks of study drug administration. The change from baseline was calculated. Results were reported as a M-estimate.
COMPLETED
PHASE3
321 participants
Baseline and Week 12
2024-05-16
Participant Flow
Participant milestones
| Measure |
Ezetimibe 10 mg
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
|
Rosuvastatin 2.5 mg
1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
|
Rosuvastatin 5.0 mg
2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 2.5 mg
1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 5.0 mg
1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
72
|
71
|
71
|
72
|
|
Overall Study
COMPLETED
|
35
|
71
|
71
|
67
|
70
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
4
|
2
|
Reasons for withdrawal
| Measure |
Ezetimibe 10 mg
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
|
Rosuvastatin 2.5 mg
1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
|
Rosuvastatin 5.0 mg
2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 2.5 mg
1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 5.0 mg
1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
2
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of the Efficacy and Safety of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-832)
Baseline characteristics by cohort
| Measure |
Ezetimibe 10 mg
n=35 Participants
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
|
Rosuvastatin 2.5 mg
n=72 Participants
1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
|
Rosuvastatin 5.0 mg
n=71 Participants
2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 2.5 mg
n=71 Participants
1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 5.0 mg
n=72 Participants
1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
|
Total
n=321 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.0 Years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
55.7 Years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
58.9 Years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
56.0 Years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
58.2 Years
STANDARD_DEVIATION 10.6 • n=21 Participants
|
57.0 Years
STANDARD_DEVIATION 10.1 • n=8 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
166 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
155 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
35 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
72 Participants
n=21 Participants
|
321 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who received at least 1 dose of study drug, had baseline or post-baseline data and had baseline data for those analyses that required baseline data.
Participants had LDL-C levels assessed at baseline and after 12 weeks of study drug administration. The change from baseline was calculated. Results were reported as a M-estimate.
Outcome measures
| Measure |
Ezetimibe 10 mg+ Rosuvastatin 5.0 mg
n=72 Participants
1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
|
Ezetimibe 10 mg
n=35 Participants
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
|
Rosuvastatin 2.5 mg
n=72 Participants
1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
|
Rosuvastatin 5.0 mg
n=71 Participants
2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 2.5 mg
n=71 Participants
1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C)
|
-60.5 Percentage Change
Interval -62.8 to -58.2
|
-18.7 Percentage Change
Interval -21.9 to -15.5
|
-39.8 Percentage Change
Interval -42.0 to -37.5
|
-47.2 Percentage Change
Interval -49.4 to -44.9
|
-54.6 Percentage Change
Interval -56.9 to -52.3
|
PRIMARY outcome
Timeframe: up to 14 weeksPopulation: All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.
An AE was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized
Outcome measures
| Measure |
Ezetimibe 10 mg+ Rosuvastatin 5.0 mg
n=72 Participants
1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
|
Ezetimibe 10 mg
n=35 Participants
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
|
Rosuvastatin 2.5 mg
n=72 Participants
1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
|
Rosuvastatin 5.0 mg
n=71 Participants
2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 2.5 mg
n=71 Participants
1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Experience at Least 1 Adverse Event (AE)
|
37.5 Percentage of Participants
|
31.4 Percentage of Participants
|
34.7 Percentage of Participants
|
42.3 Percentage of Participants
|
40.8 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to 12 weeksPopulation: All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.
An AE was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants that had study drug discontinued due to an AE was summarized.
Outcome measures
| Measure |
Ezetimibe 10 mg+ Rosuvastatin 5.0 mg
n=72 Participants
1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
|
Ezetimibe 10 mg
n=35 Participants
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
|
Rosuvastatin 2.5 mg
n=72 Participants
1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
|
Rosuvastatin 5.0 mg
n=71 Participants
2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 2.5 mg
n=71 Participants
1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Had Study Drug Discontinued Due to Adverse Event
|
1.4 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
2.8 Percentage of participants
|
PRIMARY outcome
Timeframe: up to 14 weeksPopulation: All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.
Gastrointestinal-related AEs included all preferred terms within system organ class of Gastrointestinal Disorders except Chapped Lips and Toothache.
Outcome measures
| Measure |
Ezetimibe 10 mg+ Rosuvastatin 5.0 mg
n=72 Participants
1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
|
Ezetimibe 10 mg
n=35 Participants
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
|
Rosuvastatin 2.5 mg
n=72 Participants
1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
|
Rosuvastatin 5.0 mg
n=71 Participants
2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 2.5 mg
n=71 Participants
1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Experience 1 or More Gastrointestinal-related AEs
|
2.8 Percentage of Participants
|
0.0 Percentage of Participants
|
6.9 Percentage of Participants
|
4.2 Percentage of Participants
|
8.5 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to 14 weeksPopulation: All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.
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.
Outcome measures
| Measure |
Ezetimibe 10 mg+ Rosuvastatin 5.0 mg
n=72 Participants
1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
|
Ezetimibe 10 mg
n=35 Participants
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
|
Rosuvastatin 2.5 mg
n=72 Participants
1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
|
Rosuvastatin 5.0 mg
n=71 Participants
2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 2.5 mg
n=71 Participants
1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Experience 1 or More Gallbladder-related AEs
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to 14 weeksPopulation: All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.
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.
Outcome measures
| Measure |
Ezetimibe 10 mg+ Rosuvastatin 5.0 mg
n=72 Participants
1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
|
Ezetimibe 10 mg
n=35 Participants
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
|
Rosuvastatin 2.5 mg
n=72 Participants
1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
|
Rosuvastatin 5.0 mg
n=71 Participants
2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 2.5 mg
n=71 Participants
1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Experience 1 or More Allergic Reaction or Rash AEs
|
2.8 Percentage of Participants
|
0.0 Percentage of Participants
|
1.4 Percentage of Participants
|
4.2 Percentage of Participants
|
2.8 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to 14 weeksPopulation: All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.
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.
Outcome measures
| Measure |
Ezetimibe 10 mg+ Rosuvastatin 5.0 mg
n=72 Participants
1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
|
Ezetimibe 10 mg
n=35 Participants
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
|
Rosuvastatin 2.5 mg
n=72 Participants
1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
|
Rosuvastatin 5.0 mg
n=71 Participants
2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 2.5 mg
n=71 Participants
1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Experience 1 or More Hepatitis-related AEs
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to 12 weeksPopulation: All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.
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.
Outcome measures
| Measure |
Ezetimibe 10 mg+ Rosuvastatin 5.0 mg
n=72 Participants
1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
|
Ezetimibe 10 mg
n=35 Participants
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
|
Rosuvastatin 2.5 mg
n=72 Participants
1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
|
Rosuvastatin 5.0 mg
n=71 Participants
2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 2.5 mg
n=71 Participants
1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) ≥3 Times Upper Normal Limit (ULN)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
1.4 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to 12 weeksPopulation: All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.
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..
Outcome measures
| Measure |
Ezetimibe 10 mg+ Rosuvastatin 5.0 mg
n=72 Participants
1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
|
Ezetimibe 10 mg
n=35 Participants
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
|
Rosuvastatin 2.5 mg
n=72 Participants
1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
|
Rosuvastatin 5.0 mg
n=71 Participants
2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 2.5 mg
n=71 Participants
1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Experience Consecutive Elevations in Aspartate Aminotransferase (AST) ≥3 Times Upper Normal Limit (ULN)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to 12 weeksPopulation: All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.
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.
Outcome measures
| Measure |
Ezetimibe 10 mg+ Rosuvastatin 5.0 mg
n=72 Participants
1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
|
Ezetimibe 10 mg
n=35 Participants
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
|
Rosuvastatin 2.5 mg
n=72 Participants
1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
|
Rosuvastatin 5.0 mg
n=71 Participants
2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 2.5 mg
n=71 Participants
1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) ≥3 Times Upper Normal Limit (ULN)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
1.4 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to 12 weeksPopulation: All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.
Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had an assessments of ALT that was 5x ULN or greater were recorded. The ALT ULN was 40 U/L.
Outcome measures
| Measure |
Ezetimibe 10 mg+ Rosuvastatin 5.0 mg
n=72 Participants
1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
|
Ezetimibe 10 mg
n=35 Participants
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
|
Rosuvastatin 2.5 mg
n=72 Participants
1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
|
Rosuvastatin 5.0 mg
n=71 Participants
2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 2.5 mg
n=71 Participants
1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Experience Elevation in Alanine Aminotransferase (ALT) ≥5 Times Upper Normal Limit (ULN)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to 12 weeksPopulation: All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.
Participants had AST levels assessed throughout the 12 week treatment period. Participants who had an assessments of AST that was 5x ULN or greater were recorded. The AST ULN was 40 U/L.
Outcome measures
| Measure |
Ezetimibe 10 mg+ Rosuvastatin 5.0 mg
n=72 Participants
1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
|
Ezetimibe 10 mg
n=35 Participants
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
|
Rosuvastatin 2.5 mg
n=72 Participants
1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
|
Rosuvastatin 5.0 mg
n=71 Participants
2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 2.5 mg
n=71 Participants
1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Experience Elevation in Aspartate Aminotransferase (AST) ≥5 Times Upper Normal Limit (ULN)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to 12 weeksPopulation: All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.
Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had an assessments of ALT that was 10x ULN or greater were recorded. The ALT ULN was 40 U/L.
Outcome measures
| Measure |
Ezetimibe 10 mg+ Rosuvastatin 5.0 mg
n=72 Participants
1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
|
Ezetimibe 10 mg
n=35 Participants
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
|
Rosuvastatin 2.5 mg
n=72 Participants
1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
|
Rosuvastatin 5.0 mg
n=71 Participants
2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 2.5 mg
n=71 Participants
1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Experience Elevation in Alanine Aminotransferase (ALT) ≥10 Times Upper Normal Limit (ULN)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to 12 weeksPopulation: All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.
Participants had AST levels assessed throughout the 12 week treatment period. Participants who had an assessments of AST that was 10x ULN or greater were recorded. The AST ULN was 40 U/L.
Outcome measures
| Measure |
Ezetimibe 10 mg+ Rosuvastatin 5.0 mg
n=72 Participants
1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
|
Ezetimibe 10 mg
n=35 Participants
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
|
Rosuvastatin 2.5 mg
n=72 Participants
1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
|
Rosuvastatin 5.0 mg
n=71 Participants
2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 2.5 mg
n=71 Participants
1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Experience Elevation in Aspartate Aminotransferase (AST) ≥10 Times Upper Normal Limit (ULN)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to 12 weeksPopulation: All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.
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.
Outcome measures
| Measure |
Ezetimibe 10 mg+ Rosuvastatin 5.0 mg
n=72 Participants
1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
|
Ezetimibe 10 mg
n=35 Participants
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
|
Rosuvastatin 2.5 mg
n=72 Participants
1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
|
Rosuvastatin 5.0 mg
n=71 Participants
2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 2.5 mg
n=71 Participants
1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) ≥10 Times Upper Normal Limit (ULN)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to 12 weeksPopulation: All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.
Percentage of Participants with Potential Hy's Law Condition (defined as serum ALT or serum AST elevations \>3xULN, with serum alkalinephosphatase \<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.
Outcome measures
| Measure |
Ezetimibe 10 mg+ Rosuvastatin 5.0 mg
n=72 Participants
1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
|
Ezetimibe 10 mg
n=35 Participants
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
|
Rosuvastatin 2.5 mg
n=72 Participants
1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
|
Rosuvastatin 5.0 mg
n=71 Participants
2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 2.5 mg
n=71 Participants
1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Potential Hy's Law Condition
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to 12 weeksPopulation: All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.
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.
Outcome measures
| Measure |
Ezetimibe 10 mg+ Rosuvastatin 5.0 mg
n=72 Participants
1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
|
Ezetimibe 10 mg
n=35 Participants
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
|
Rosuvastatin 2.5 mg
n=72 Participants
1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
|
Rosuvastatin 5.0 mg
n=71 Participants
2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 2.5 mg
n=71 Participants
1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to 12 weeksPopulation: All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.
Participants had CK levels assessed throughout the 52 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.
Outcome measures
| Measure |
Ezetimibe 10 mg+ Rosuvastatin 5.0 mg
n=72 Participants
1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
|
Ezetimibe 10 mg
n=35 Participants
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
|
Rosuvastatin 2.5 mg
n=72 Participants
1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
|
Rosuvastatin 5.0 mg
n=71 Participants
2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 2.5 mg
n=71 Participants
1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN With Muscle Symptoms
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to 12 weeksPopulation: All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.
Participants had CK levels assessed throughout the 52 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.
Outcome measures
| Measure |
Ezetimibe 10 mg+ Rosuvastatin 5.0 mg
n=72 Participants
1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
|
Ezetimibe 10 mg
n=35 Participants
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
|
Rosuvastatin 2.5 mg
n=72 Participants
1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
|
Rosuvastatin 5.0 mg
n=71 Participants
2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 2.5 mg
n=71 Participants
1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN and Drug-Related Muscle Symptoms
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
Adverse Events
Ezetimibe 10 mg
Rosuvastatin 2.5 mg
Rosuvastatin 5.0 mg
Ezetimibe 10 mg+ Rosuvastatin 2.5 mg
Ezetimibe 10 mg+ Rosuvastatin 5.0 mg
Serious adverse events
| Measure |
Ezetimibe 10 mg
n=35 participants at risk
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
|
Rosuvastatin 2.5 mg
n=72 participants at risk
1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
|
Rosuvastatin 5.0 mg
n=71 participants at risk
2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 2.5 mg
n=71 participants at risk
1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 5.0 mg
n=72 participants at risk
1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Infections and infestations
Bacterial prostatitis
|
0.00%
0/35 • up to 2 weeks post last dose of study drug (up to 14 weeks total)
All participants that received at least 1 dose of study drug.
|
0.00%
0/72 • up to 2 weeks post last dose of study drug (up to 14 weeks total)
All participants that received at least 1 dose of study drug.
|
1.4%
1/71 • Number of events 1 • up to 2 weeks post last dose of study drug (up to 14 weeks total)
All participants that received at least 1 dose of study drug.
|
0.00%
0/71 • up to 2 weeks post last dose of study drug (up to 14 weeks total)
All participants that received at least 1 dose of study drug.
|
0.00%
0/72 • up to 2 weeks post last dose of study drug (up to 14 weeks total)
All participants that received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Ezetimibe 10 mg
n=35 participants at risk
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
|
Rosuvastatin 2.5 mg
n=72 participants at risk
1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
|
Rosuvastatin 5.0 mg
n=71 participants at risk
2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 2.5 mg
n=71 participants at risk
1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
|
Ezetimibe 10 mg+ Rosuvastatin 5.0 mg
n=72 participants at risk
1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
17.1%
6/35 • Number of events 6 • up to 2 weeks post last dose of study drug (up to 14 weeks total)
All participants that received at least 1 dose of study drug.
|
11.1%
8/72 • Number of events 9 • up to 2 weeks post last dose of study drug (up to 14 weeks total)
All participants that received at least 1 dose of study drug.
|
15.5%
11/71 • Number of events 12 • up to 2 weeks post last dose of study drug (up to 14 weeks total)
All participants that received at least 1 dose of study drug.
|
8.5%
6/71 • Number of events 6 • up to 2 weeks post last dose of study drug (up to 14 weeks total)
All participants that received at least 1 dose of study drug.
|
9.7%
7/72 • Number of events 8 • up to 2 weeks post last dose of study drug (up to 14 weeks total)
All participants that received at least 1 dose of study drug.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER