Trial Outcomes & Findings for Effects of Statin and Ezetimibe Association on Kinetics of Artificial Chilomicrons (NCT NCT00481351)
NCT ID: NCT00481351
Last Updated: 2011-01-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
25 participants
Primary outcome timeframe
6 weeks
Results posted on
2011-01-26
Participant Flow
Participant milestones
| Measure |
group1 Ezetimibe
6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
|
Group 2 Simvastatin
6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Statin and Ezetimibe Association on Kinetics of Artificial Chilomicrons
Baseline characteristics by cohort
| Measure |
group1 Ezetimibe
n=13 Participants
6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
|
Group 2 Simvastatin
n=12 Participants
6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age Continuous
|
61.23 years
STANDARD_DEVIATION 6.4 • n=99 Participants
|
60.08 years
STANDARD_DEVIATION 3.42 • n=107 Participants
|
60.68 years
STANDARD_DEVIATION 4.96 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Waist
|
94.85 cm
STANDARD_DEVIATION 9.18 • n=99 Participants
|
97.08 cm
STANDARD_DEVIATION 8.63 • n=107 Participants
|
95.92 cm
STANDARD_DEVIATION 8.81 • n=206 Participants
|
|
Body Mass Index
|
27.11 kg/m2
STANDARD_DEVIATION 3.41 • n=99 Participants
|
27.96 kg/m2
STANDARD_DEVIATION 3.63 • n=107 Participants
|
27.96 kg/m2
STANDARD_DEVIATION 3.63 • n=206 Participants
|
|
alanine aminotransferase
|
24.23 mg/dl
STANDARD_DEVIATION 11.54 • n=99 Participants
|
20 mg/dl
STANDARD_DEVIATION 4.88 • n=107 Participants
|
22.2 mg/dl
STANDARD_DEVIATION 9.06 • n=206 Participants
|
|
Glucose
|
93.46 mg/dl
STANDARD_DEVIATION 9.40 • n=99 Participants
|
102.17 mg/dl
STANDARD_DEVIATION 11.39 • n=107 Participants
|
97.64 mg/dl
STANDARD_DEVIATION 11.10 • n=206 Participants
|
|
Apolipoprotein A
|
139.18 mg/dl
STANDARD_DEVIATION 29.36 • n=99 Participants
|
136.5 mg/dl
STANDARD_DEVIATION 30.66 • n=107 Participants
|
137.89 mg/dl
STANDARD_DEVIATION 29.39 • n=206 Participants
|
|
Apolipoprotein B
|
123.67 mg/dl
STANDARD_DEVIATION 32.99 • n=99 Participants
|
115.74 mg/dl
STANDARD_DEVIATION 19.37 • n=107 Participants
|
119.86 mg/dl
STANDARD_DEVIATION 27.06 • n=206 Participants
|
|
Total cholesterol
|
222.54 mg/dl
STANDARD_DEVIATION 24.35 • n=99 Participants
|
215.33 mg/dl
STANDARD_DEVIATION 33.32 • n=107 Participants
|
219.08 mg/dl
STANDARD_DEVIATION 28.61 • n=206 Participants
|
|
Low Density Lipoprotein
|
141.85 mg/dl
STANDARD_DEVIATION 21.91 • n=99 Participants
|
139.42 mg/dl
STANDARD_DEVIATION 22.19 • n=107 Participants
|
140.68 mg/dl
STANDARD_DEVIATION 21.61 • n=206 Participants
|
|
High Density Lipoprotein
|
48.08 mg/dl
STANDARD_DEVIATION 11.88 • n=99 Participants
|
45.08 mg/dl
STANDARD_DEVIATION 13.04 • n=107 Participants
|
46.64 mg/dl
STANDARD_DEVIATION 12.28 • n=206 Participants
|
|
Triglycerides
|
165.23 mg/dl
STANDARD_DEVIATION 80.76 • n=99 Participants
|
213.75 mg/dl
STANDARD_DEVIATION 112.85 • n=107 Participants
|
188.52 mg/dl
STANDARD_DEVIATION 19.60 • n=206 Participants
|
|
cholesteryl ester fractional clearance rate
|
0.0051 min-1
STANDARD_DEVIATION 0.0046 • n=99 Participants
|
0.0046 min-1
STANDARD_DEVIATION 0.0029 • n=107 Participants
|
0.0048576 min-1
STANDARD_DEVIATION 0.00381 • n=206 Participants
|
|
triglycerides fractional clearance rate
|
0.0171 min-1
STANDARD_DEVIATION 0.0108 • n=99 Participants
|
0.0161 min-1
STANDARD_DEVIATION 0.0096 • n=107 Participants
|
0.016602 min-1
STANDARD_DEVIATION 0.01004 • n=206 Participants
|
PRIMARY outcome
Timeframe: 6 weeksOutcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 12weekOutcome measures
| Measure |
group1 Ezetimibe
n=13 Participants
6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
|
Group 2 Simvastatin
n=12 Participants
6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
|
|---|---|---|
|
Low Density Lipoprotein
|
74.85 mg/dl
Standard Deviation 16.76
|
71.92 mg/dl
Standard Deviation 15.35
|
SECONDARY outcome
Timeframe: 6weekOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
group1 Ezetimibe
n=13 Participants
6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
|
Group 2 Simvastatin
n=12 Participants
6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
|
|---|---|---|
|
Alanine Aminotransferase
|
30.46 mg/dl
Standard Deviation 16.08
|
18.33 mg/dl
Standard Deviation 8.08
|
SECONDARY outcome
Timeframe: 12 weekOutcome measures
| Measure |
group1 Ezetimibe
n=13 Participants
6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
|
Group 2 Simvastatin
n=12 Participants
6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
|
|---|---|---|
|
CPK
|
169 mg/dl
Standard Deviation 95.41
|
131 mg/dl
Standard Deviation 97.54
|
SECONDARY outcome
Timeframe: 12 weekOutcome measures
| Measure |
group1 Ezetimibe
n=13 Participants
6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
|
Group 2 Simvastatin
n=12 Participants
6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
|
|---|---|---|
|
Total Cholesterol
|
152.61 mg/dl
Standard Deviation 26.36
|
148.29 mg/dl
Standard Deviation 21.29
|
SECONDARY outcome
Timeframe: 12 weekOutcome measures
| Measure |
group1 Ezetimibe
n=13 Participants
6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
|
Group 2 Simvastatin
n=12 Participants
6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
|
|---|---|---|
|
High Density Lipoprotein
|
51.31 mg/dl
Standard Deviation 16.33
|
44.33 mg/dl
Standard Deviation 14.13
|
Adverse Events
group1 Ezetimibe
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2 Simvastatin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place