Trial Outcomes & Findings for Adding Ezetimibe Tablet to Ongoing Treatment With Atorvastatin in Subjects With High Cholesterol and Multiple Coronary Heart Disease Risk Factors (Study P04060)(COMPLETED) (NCT NCT00319449)
NCT ID: NCT00319449
Last Updated: 2022-02-09
Results Overview
12-hour fasting blood samples were collected in participants to measure high density lipoprotein-cholesterol (HDL-C), triglycerides and total cholesterol. LDL-C was measured using Friedewald calculation (LDL-C = Total C - \[HDL-C + TG/5\]) before and after treatment.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
22 participants
Primary outcome timeframe
Baseline and 6 weeks
Results posted on
2022-02-09
Participant Flow
Participant milestones
| Measure |
Ezetimibe 10 mg
Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
|
Placebo 10 mg
Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
12
|
|
Overall Study
COMPLETED
|
8
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Ezetimibe 10 mg
Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
|
Placebo 10 mg
Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
|
|---|---|---|
|
Overall Study
Subject did not wish to continue
|
1
|
0
|
|
Overall Study
Noncompliance with the protocol
|
1
|
0
|
Baseline Characteristics
Adding Ezetimibe Tablet to Ongoing Treatment With Atorvastatin in Subjects With High Cholesterol and Multiple Coronary Heart Disease Risk Factors (Study P04060)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Ezetimibe 10 mg
n=10 Participants
Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
|
Placebo 10 mg
n=12 Participants
Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.4 Years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
52.2 Years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
54.5 Years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Age, Customized
18 to <65 years
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Customized
65 or older
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
Indonesia
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 weeksPopulation: Participants who completed the study.
12-hour fasting blood samples were collected in participants to measure high density lipoprotein-cholesterol (HDL-C), triglycerides and total cholesterol. LDL-C was measured using Friedewald calculation (LDL-C = Total C - \[HDL-C + TG/5\]) before and after treatment.
Outcome measures
| Measure |
Ezetimibe 10 mg
n=8 Participants
Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
|
Placebo 10 mg
n=12 Participants
Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
|
|---|---|---|
|
Low Density Lipoprotein-cholesterol (LDL-C) at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg
Baseline
|
148.125 mg/dL
Interval 130.126 to 166.124
|
151.083 mg/dL
Interval 136.387 to 165.78
|
|
Low Density Lipoprotein-cholesterol (LDL-C) at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg
6 weeks post treatment
|
106.000 mg/dL
Interval 89.03 to 122.97
|
108.273 mg/dL
Interval 92.923 to 123.622
|
SECONDARY outcome
Timeframe: 6 weeks post treatmentPopulation: Participants who completed the study.
12-hour fasting blood samples were collected in participants to measure high density lipoprotein-cholesterol (HDL-C), triglycerides and total cholesterol. LDL-C was measured using Friedewald calculation (LDL-C = Total C - \[HDL-C + TG/5\] after treatment for 6 weeks.
Outcome measures
| Measure |
Ezetimibe 10 mg
n=8 Participants
Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
|
Placebo 10 mg
n=12 Participants
Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
|
|---|---|---|
|
Number of Participants Who Achieve the Target LDL-C Concentration of < 3.3 mmol/L (130 mg/dL)
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 6 weeks post treatmentPopulation: Participants who completed the study.
12-hour fasting blood samples were collected in participants and the high density lipoprotein-cholesterol (HDL-C), triglycerides and total cholesterol was measured with the basic lipid panel test.
Outcome measures
| Measure |
Ezetimibe 10 mg
n=8 Participants
Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
|
Placebo 10 mg
n=12 Participants
Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
|
|---|---|---|
|
High Density Lipoprotein-cholesterol (HDL-C), Total Cholesterol and Triglycerides at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg
HDL-C at 6 weeks
|
52.625 mg/dL
Interval 43.954 to 61.296
|
53.500 mg/dL
Interval 46.42 to 60.58
|
|
High Density Lipoprotein-cholesterol (HDL-C), Total Cholesterol and Triglycerides at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg
HDL-C at baseline
|
53.250 mg/dL
Interval 44.579 to 61.921
|
57.667 mg/dL
Interval 50.586 to 67.747
|
|
High Density Lipoprotein-cholesterol (HDL-C), Total Cholesterol and Triglycerides at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg
Total Cholesterol at baseline
|
219.125 mg/dL
Interval 202.355 to 235.895
|
226.000 mg/dL
Interval 212.307 to 239.693
|
|
High Density Lipoprotein-cholesterol (HDL-C), Total Cholesterol and Triglycerides at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg
Total Cholesterol at 6 weeks
|
156.375 mg/dL
Interval 139.605 to 173.145
|
185.667 mg/dL
Interval 171.974 to 199.359
|
|
High Density Lipoprotein-cholesterol (HDL-C), Total Cholesterol and Triglycerides at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg
Triglycerides at baseline
|
139.500 mg/dL
Interval 105.213 to 173.787
|
131.667 mg/dL
Interval 103.672 to 159.662
|
|
High Density Lipoprotein-cholesterol (HDL-C), Total Cholesterol and Triglycerides at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg
Triglycerides at 6 weeks
|
115.250 mg/dL
Interval 80.963 to 149.537
|
120.250 mg/dL
Interval 92.255 to 148.245
|
Adverse Events
Ezetimibe 10 mg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo 10 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ezetimibe 10 mg
n=10 participants at risk
Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
|
Placebo 10 mg
n=12 participants at risk
Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
|
|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
10.0%
1/10
|
0.00%
0/12
|
Other adverse events
| Measure |
Ezetimibe 10 mg
n=10 participants at risk
Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
|
Placebo 10 mg
n=12 participants at risk
Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/10
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/10
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
1/10
|
0.00%
0/12
|
|
Nervous system disorders
Headache
|
10.0%
1/10
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
pruritis
|
10.0%
1/10
|
0.00%
0/12
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The principal investigator (PI) agrees not to publish or publicly present any interim results of the Study without prior written consent of the SPONSOR. The PI further agrees to provide thirty (30) days written notice to the SPONSOR prior to submission for publication or presentation to allow SPONSOR to review abstracts or manuscripts for publication.
- Publication restrictions are in place
Restriction type: OTHER