Trial Outcomes & Findings for Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED) (NCT NCT00871351)
NCT ID: NCT00871351
Last Updated: 2024-05-23
Results Overview
LDL-C was measured before group study drug administration (Week 4, end of atorvastatin single therapy) and at the end of study drug administration (after 12 weeks of study drug treatment, or at discontinuation).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
125 participants
Primary outcome timeframe
End of Week 4 to Week 16 or discontinuation
Results posted on
2024-05-23
Participant Flow
Participant milestones
| Measure |
Ezetimibe + Atorvastatin
Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
Atorvastatin
Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
Rosuvastatin
Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
|---|---|---|---|
|
Overall Study
STARTED
|
47
|
46
|
32
|
|
Overall Study
COMPLETED
|
43
|
45
|
32
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
0
|
Reasons for withdrawal
| Measure |
Ezetimibe + Atorvastatin
Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
Atorvastatin
Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
Rosuvastatin
Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
3
|
1
|
0
|
Baseline Characteristics
Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Ezetimibe + Atorvastatin
n=47 Participants
Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
Atorvastatin
n=46 Participants
Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
Rosuvastatin
n=32 Participants
Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
59.3 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
61.1 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
61.0 years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
47 participants
n=5 Participants
|
46 participants
n=7 Participants
|
32 participants
n=5 Participants
|
125 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: End of Week 4 to Week 16 or discontinuationPopulation: Randomized participants
LDL-C was measured before group study drug administration (Week 4, end of atorvastatin single therapy) and at the end of study drug administration (after 12 weeks of study drug treatment, or at discontinuation).
Outcome measures
| Measure |
Ezetimibe + Atorvastatin
n=47 Participants
Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
Atorvastatin
n=46 Participants
Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
Rosuvastatin
n=32 Participants
Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
|---|---|---|---|
|
Percent Change in Low-Density Lipoprotein - Cholesterol (LDL-C) Values
|
-25.8 Percent change
Interval -29.2 to -22.4
|
-15.1 Percent change
Interval -18.6 to -11.7
|
0.8 Percent change
Interval -3.3 to 4.9
|
SECONDARY outcome
Timeframe: End of washout period to Week 16 or discontinuationPopulation: Randomized participants
LDL-C was measured at the start of the atorvastatin 10 mg treatment period (end of the washout period) and at the end of administration of the study drug (Week 16 or discontinuation).
Outcome measures
| Measure |
Ezetimibe + Atorvastatin
n=47 Participants
Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
Atorvastatin
n=46 Participants
Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
Rosuvastatin
n=32 Participants
Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
|---|---|---|---|
|
Percent Change in LDL-C
|
-49.6 Percent change
Interval -52.9 to -46.4
|
-41.1 Percent change
Interval -44.4 to -37.9
|
-30.5 Percent change
Interval -34.4 to -26.6
|
SECONDARY outcome
Timeframe: Week 16 or discontinuationPopulation: Randomized participants
LDL-C was measured at the end of administration of the study drug (Week 16 or discontinuation). Target values: For participants with history of coronary artery disease: \<100 mg/dL; for participants with at least 3 cardiovascular (CV) risk factors: \<120 mg/dL; for participants with 1-2 CV risk factors: \<140 mg/dL; for participants with no CV risk factors: \<160 mg/dL.
Outcome measures
| Measure |
Ezetimibe + Atorvastatin
n=47 Participants
Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
Atorvastatin
n=46 Participants
Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
Rosuvastatin
n=32 Participants
Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
|---|---|---|---|
|
Number of Participants Whose LDL-C Levels Reached the Lipid Management Target Values
|
37 Participants
|
19 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: End of Week 4 to Week 16 or discontinuationPopulation: Randomized participants
Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at 4 weeks after the start of the treatment period (after completion of administration of atorvastatin 10 mg alone) and at Week 16 or at discontinuation.
Outcome measures
| Measure |
Ezetimibe + Atorvastatin
n=47 Participants
Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
Atorvastatin
n=46 Participants
Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
Rosuvastatin
n=32 Participants
Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
|---|---|---|---|
|
Percent Change in Total Lipids and High Sensitivity C-reactive Protein (Hs-CRP)
High-Density Lipoprotein Cholesterol (HDL-C)
|
4.5 Percent change
Interval 0.9 to 8.2
|
0.5 Percent change
Interval -2.6 to 3.5
|
2.5 Percent change
Interval -1.4 to 6.4
|
|
Percent Change in Total Lipids and High Sensitivity C-reactive Protein (Hs-CRP)
Non-HDL-C
|
-25.0 Percent change
Interval -28.5 to -21.5
|
-13.7 Percent change
Interval -17.0 to -10.3
|
2.0 Percent change
Interval -2.6 to 6.5
|
|
Percent Change in Total Lipids and High Sensitivity C-reactive Protein (Hs-CRP)
High Sensitivity C-Reactive Protein (Hs-CRP)
|
49.0 Percent change
Interval -43.2 to 141.3
|
9.9 Percent change
Interval -24.1 to 43.9
|
25.7 Percent change
Interval -4.8 to 56.1
|
|
Percent Change in Total Lipids and High Sensitivity C-reactive Protein (Hs-CRP)
Total Cholesterol
|
-18.0 Percent change
Interval -20.7 to -15.2
|
-10.3 Percent change
Interval -13.1 to -7.4
|
1.9 Percent change
Interval -1.7 to 5.5
|
|
Percent Change in Total Lipids and High Sensitivity C-reactive Protein (Hs-CRP)
Triglycerides
|
-0.8 Percent change
Interval -14.4 to 12.8
|
0.2 Percent change
Interval -10.9 to 11.4
|
14.7 Percent change
Interval 2.3 to 27.0
|
SECONDARY outcome
Timeframe: End of washout to Week 16 or discontinuationPopulation: Randomized participants
Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at the start of the treatment period (at start of administration of atorvastatin 10 mg alone) and at the end of study drug (Week 16 or discontinuation).
Outcome measures
| Measure |
Ezetimibe + Atorvastatin
n=47 Participants
Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
Atorvastatin
n=46 Participants
Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
Rosuvastatin
n=32 Participants
Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
|---|---|---|---|
|
Percent Change in Total Lipids and Hs-CRP
Total Cholesterol
|
-39.9 Percent change
Interval -42.1 to -37.7
|
-32.8 Percent change
Interval -35.8 to -29.7
|
-24.4 Percent change
Interval -27.9 to -21.0
|
|
Percent Change in Total Lipids and Hs-CRP
Triglycerides
|
-25.3 Percent change
Interval -36.0 to -14.6
|
-18.8 Percent change
Interval -29.8 to -7.8
|
-12.0 Percent change
Interval -21.3 to -2.7
|
|
Percent Change in Total Lipids and Hs-CRP
High-Density Lipoprotein Cholesterol (HDL-C)
|
10.3 Percent change
Interval 6.1 to 14.5
|
7.4 Percent change
Interval 3.7 to 11.0
|
9.9 Percent change
Interval 3.6 to 16.2
|
|
Percent Change in Total Lipids and Hs-CRP
Non-HDL-C
|
-50.1 Percent change
Interval -52.7 to -47.6
|
-41.4 Percent change
Interval -44.8 to -37.9
|
-31.3 Percent change
Interval -35.4 to -27.1
|
|
Percent Change in Total Lipids and Hs-CRP
High Sensitivity C-reactive Protein (Hs-CRP)
|
73.0 Percent change
Interval -84.4 to 230.4
|
-2.9 Percent change
Interval -36.3 to 30.4
|
-13.6 Percent change
Interval -39.7 to 12.6
|
Adverse Events
Ezetimibe + Atorvastatin
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Atorvastatin
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Rosuvastatin
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ezetimibe + Atorvastatin
n=47 participants at risk
Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
Atorvastatin
n=46 participants at risk
Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
Rosuvastatin
n=32 participants at risk
Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
|---|---|---|---|
|
General disorders
Chest discomfort
|
2.1%
1/47 • Number of events 1
Randomized participants
|
0.00%
0/46
Randomized participants
|
0.00%
0/32
Randomized participants
|
|
Infections and infestations
Pneumonia
|
0.00%
0/47
Randomized participants
|
2.2%
1/46 • Number of events 1
Randomized participants
|
0.00%
0/32
Randomized participants
|
|
Injury, poisoning and procedural complications
Heat illness
|
2.1%
1/47 • Number of events 1
Randomized participants
|
0.00%
0/46
Randomized participants
|
0.00%
0/32
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the gastrointestinal tract
|
2.1%
1/47 • Number of events 1
Randomized participants
|
0.00%
0/46
Randomized participants
|
0.00%
0/32
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
2.1%
1/47 • Number of events 1
Randomized participants
|
0.00%
0/46
Randomized participants
|
0.00%
0/32
Randomized participants
|
Other adverse events
| Measure |
Ezetimibe + Atorvastatin
n=47 participants at risk
Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
Atorvastatin
n=46 participants at risk
Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
Rosuvastatin
n=32 participants at risk
Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
14.9%
7/47 • Number of events 8
Randomized participants
|
10.9%
5/46 • Number of events 6
Randomized participants
|
9.4%
3/32 • Number of events 4
Randomized participants
|
|
Investigations
Blood creatine phosphokinase increased
|
6.4%
3/47 • Number of events 4
Randomized participants
|
0.00%
0/46
Randomized participants
|
0.00%
0/32
Randomized participants
|
|
Nervous system disorders
Dizziness
|
0.00%
0/47
Randomized participants
|
0.00%
0/46
Randomized participants
|
6.2%
2/32 • Number of events 2
Randomized participants
|
|
Nervous system disorders
Headache
|
2.1%
1/47 • Number of events 1
Randomized participants
|
0.00%
0/46
Randomized participants
|
9.4%
3/32 • Number of events 3
Randomized participants
|
|
Vascular disorders
Hypertension
|
4.3%
2/47 • Number of events 2
Randomized participants
|
0.00%
0/46
Randomized participants
|
9.4%
3/32 • Number of events 3
Randomized participants
|
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 investigator agrees not to publish/present any interim results of the study without Sponsor's prior written consent. The investigator further agrees to provide to the sponsor 45 days prior to submission, review copies of abstracts/manuscripts that report any study results. The sponsor has the right to review and comment. If the parties disagree, investigator agrees to meet with the sponsor for the purpose of making good faith efforts to discuss and resolve any such issues or disagreement.
- Publication restrictions are in place
Restriction type: OTHER