Trial Outcomes & Findings for A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-833) (NCT NCT02748057)
NCT ID: NCT02748057
Last Updated: 2024-05-16
Results Overview
An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants who reported at least 1 AE was summarized.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
135 participants
Primary outcome timeframe
Up to 2 weeks post last dose of study drug (up to 54 weeks)
Results posted on
2024-05-16
Participant Flow
Participant milestones
| Measure |
Ezetimibe 10 mg + Rosuvastatin 2.5 mg
1 Ezetimibe 10 mg tablet and 1 Rosuvastatin 2.5 mg capsule/tablet orally, once daily for 52 weeks. If participant does not achieve low-density lipoprotein-cholesterol (LDL-C) goal after Week 12, dosage of Rosuvastatin may have been increased to 5.0 mg
|
Ezetimibe 10 mg + Rosuvastatin 5.0 mg
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules/tablets orally, once daily for 52 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
114
|
21
|
|
Overall Study
COMPLETED
|
109
|
19
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Ezetimibe 10 mg + Rosuvastatin 2.5 mg
1 Ezetimibe 10 mg tablet and 1 Rosuvastatin 2.5 mg capsule/tablet orally, once daily for 52 weeks. If participant does not achieve low-density lipoprotein-cholesterol (LDL-C) goal after Week 12, dosage of Rosuvastatin may have been increased to 5.0 mg
|
Ezetimibe 10 mg + Rosuvastatin 5.0 mg
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules/tablets orally, once daily for 52 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Participant Moved
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-833)
Baseline characteristics by cohort
| Measure |
Ezetimibe 10 mg + Rosuvastatin 2.5 mg
n=114 Participants
1 Ezetimibe 10 mg tablet and 1 Rosuvastatin 2.5 mg capsule/tablet orally, once daily for 52 weeks. If participant does not achieve low-density lipoprotein-cholesterol (LDL-C) goal after Week 12, dosage of Rosuvastatin may have been increased to 5.0 mg
|
Ezetimibe 10 mg + Rosuvastatin 5.0 mg
n=21 Participants
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules/tablets orally, once daily for 52 weeks.
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.2 Years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
52.4 Years
STANDARD_DEVIATION 13.3 • n=7 Participants
|
57.3 Years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
114 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 weeks post last dose of study drug (up to 54 weeks)Population: All participants who received at least 1 dose of study drug during treatment period.
An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants who reported at least 1 AE was summarized.
Outcome measures
| Measure |
Ezetimibe 10 mg + Rosuvastatin 2.5 mg
n=114 Participants
1 Ezetimibe 10 mg tablet and 1 Rosuvastatin 2.5 mg capsule/tablet orally, once daily for 52 weeks. If participant does not achieve low-density lipoprotein-cholesterol (LDL-C) goal after Week 12, dosage of Rosuvastatin may have been increased to 5.0 mg
|
Ezetimibe 10 mg + Rosuvastatin 5.0 mg
n=21 Participants
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules/tablets orally, once daily for 52 weeks.
|
|---|---|---|
|
Percentage of Participants Who Experience at Least 1 Adverse Event (AE)
|
72.8 Percentage of Participants
|
76.2 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to 52 weeksPopulation: All participants who received at least 1 dose of study drug during treatment period.
An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants who had study drug discontinued due to an AE was summarized.
Outcome measures
| Measure |
Ezetimibe 10 mg + Rosuvastatin 2.5 mg
n=114 Participants
1 Ezetimibe 10 mg tablet and 1 Rosuvastatin 2.5 mg capsule/tablet orally, once daily for 52 weeks. If participant does not achieve low-density lipoprotein-cholesterol (LDL-C) goal after Week 12, dosage of Rosuvastatin may have been increased to 5.0 mg
|
Ezetimibe 10 mg + Rosuvastatin 5.0 mg
n=21 Participants
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules/tablets orally, once daily for 52 weeks.
|
|---|---|---|
|
Percentage of Participants Who Had Study Drug Discontinued Due to an AE
|
0.9 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline (predose) and Week 52Population: All participants that received at least 1 dose of study drug, had baseline data for those analyses that required baseline data and had post-baseline data for endpoint.
Blood was collected at baseline (predose) and after 52 weeks of treatment to determine LDL-C levels. LDL-C was calculated using the Friedewald equation. If triglycerides (TG) exceeded 400 mg/dL (4.6 mmol/L), LDL-C was determined by beta quantification ultracentrifugation. The percentage change from baseline at Week 52 was summarized.
Outcome measures
| Measure |
Ezetimibe 10 mg + Rosuvastatin 2.5 mg
n=108 Participants
1 Ezetimibe 10 mg tablet and 1 Rosuvastatin 2.5 mg capsule/tablet orally, once daily for 52 weeks. If participant does not achieve low-density lipoprotein-cholesterol (LDL-C) goal after Week 12, dosage of Rosuvastatin may have been increased to 5.0 mg
|
Ezetimibe 10 mg + Rosuvastatin 5.0 mg
n=17 Participants
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules/tablets orally, once daily for 52 weeks.
|
|---|---|---|
|
Percentage Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
|
-33.8 Percentage change
Interval -36.9 to -30.8
|
-23.9 Percentage change
Interval -29.1 to -18.6
|
Adverse Events
Ezetimibe 10 mg + Rosuvastatin 2.5 mg
Serious events: 2 serious events
Other events: 53 other events
Deaths: 0 deaths
Ezetimibe 10 mg + Rosuvastatin 5.0 mg
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ezetimibe 10 mg + Rosuvastatin 2.5 mg
n=114 participants at risk
1 Ezetimibe 10 mg tablet and 1 Rosuvastatin 2.5 mg capsule/tablet orally, once daily for 52 weeks. If participant does not achieve low-density lipoprotein-cholesterol (LDL-C) goal after Week 12, dosage of Rosuvastatin may have been increased to 5.0 mg
|
Ezetimibe 10 mg + Rosuvastatin 5.0 mg
n=21 participants at risk
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules/tablets orally, once daily for 52 weeks.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/114 • Up to 2 weeks post last dose of study drug (up to 54 weeks)
Population included all participants who received at least 1 dose of study drug during treatment period.
|
4.8%
1/21 • Number of events 1 • Up to 2 weeks post last dose of study drug (up to 54 weeks)
Population included all participants who received at least 1 dose of study drug during treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.88%
1/114 • Number of events 1 • Up to 2 weeks post last dose of study drug (up to 54 weeks)
Population included all participants who received at least 1 dose of study drug during treatment period.
|
0.00%
0/21 • Up to 2 weeks post last dose of study drug (up to 54 weeks)
Population included all participants who received at least 1 dose of study drug during treatment period.
|
|
Psychiatric disorders
Anxiety disorder
|
0.88%
1/114 • Number of events 1 • Up to 2 weeks post last dose of study drug (up to 54 weeks)
Population included all participants who received at least 1 dose of study drug during treatment period.
|
0.00%
0/21 • Up to 2 weeks post last dose of study drug (up to 54 weeks)
Population included all participants who received at least 1 dose of study drug during treatment period.
|
Other adverse events
| Measure |
Ezetimibe 10 mg + Rosuvastatin 2.5 mg
n=114 participants at risk
1 Ezetimibe 10 mg tablet and 1 Rosuvastatin 2.5 mg capsule/tablet orally, once daily for 52 weeks. If participant does not achieve low-density lipoprotein-cholesterol (LDL-C) goal after Week 12, dosage of Rosuvastatin may have been increased to 5.0 mg
|
Ezetimibe 10 mg + Rosuvastatin 5.0 mg
n=21 participants at risk
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules/tablets orally, once daily for 52 weeks.
|
|---|---|---|
|
Infections and infestations
Gastroenteritis
|
7.0%
8/114 • Number of events 8 • Up to 2 weeks post last dose of study drug (up to 54 weeks)
Population included all participants who received at least 1 dose of study drug during treatment period.
|
4.8%
1/21 • Number of events 2 • Up to 2 weeks post last dose of study drug (up to 54 weeks)
Population included all participants who received at least 1 dose of study drug during treatment period.
|
|
Infections and infestations
Nasopharyngitis
|
36.0%
41/114 • Number of events 69 • Up to 2 weeks post last dose of study drug (up to 54 weeks)
Population included all participants who received at least 1 dose of study drug during treatment period.
|
38.1%
8/21 • Number of events 18 • Up to 2 weeks post last dose of study drug (up to 54 weeks)
Population included all participants who received at least 1 dose of study drug during treatment period.
|
|
Infections and infestations
Rhinitis
|
0.88%
1/114 • Number of events 1 • Up to 2 weeks post last dose of study drug (up to 54 weeks)
Population included all participants who received at least 1 dose of study drug during treatment period.
|
9.5%
2/21 • Number of events 2 • Up to 2 weeks post last dose of study drug (up to 54 weeks)
Population included all participants who received at least 1 dose of study drug during treatment period.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.8%
2/114 • Number of events 2 • Up to 2 weeks post last dose of study drug (up to 54 weeks)
Population included all participants who received at least 1 dose of study drug during treatment period.
|
9.5%
2/21 • Number of events 3 • Up to 2 weeks post last dose of study drug (up to 54 weeks)
Population included all participants who received at least 1 dose of study drug during treatment period.
|
|
Investigations
Liver function test abnormal
|
2.6%
3/114 • Number of events 3 • Up to 2 weeks post last dose of study drug (up to 54 weeks)
Population included all participants who received at least 1 dose of study drug during treatment period.
|
9.5%
2/21 • Number of events 2 • Up to 2 weeks post last dose of study drug (up to 54 weeks)
Population included all participants who received at least 1 dose of study drug during treatment period.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
2.6%
3/114 • Number of events 3 • Up to 2 weeks post last dose of study drug (up to 54 weeks)
Population included all participants who received at least 1 dose of study drug during treatment period.
|
9.5%
2/21 • Number of events 2 • Up to 2 weeks post last dose of study drug (up to 54 weeks)
Population included all participants who received at least 1 dose of study drug during treatment period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.9%
9/114 • Number of events 11 • Up to 2 weeks post last dose of study drug (up to 54 weeks)
Population included all participants who received at least 1 dose of study drug during treatment period.
|
4.8%
1/21 • Number of events 1 • Up to 2 weeks post last dose of study drug (up to 54 weeks)
Population included all participants who received at least 1 dose of study drug during treatment period.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
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