Trial Outcomes & Findings for Effects of Ezetimibe, Simvastatin, and Vytorin on Reducing L5 a Subfraction of LDL in Patients With Metabolic Syndrome. (NCT NCT00988364)
NCT ID: NCT00988364
Last Updated: 2023-11-30
Results Overview
Patient's blood samples were collected before treatment. L5 were purified by ultracentrifugation then FPLC. Quantification analysis will indicate the L5 concentration (mg/dL) per group.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
0 months, at the start
Results posted on
2023-11-30
Participant Flow
Of 30 enrolled participants, 24 met inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
Ezetimibe
Participants take Ezetimibe 10mg daily for 3 months. N= 6
|
Simvastatin
Participants take Simvastatin 20mg daily for 3 months. N=6
|
Vytorin
Participants take Vytorin 20/10mg daily for 3 months. N=6
|
Placebo
Participants take Placebo tab 1 daily for 3 months. N=6
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Ezetimibe, Simvastatin, and Vytorin on Reducing L5 a Subfraction of LDL in Patients With Metabolic Syndrome.
Baseline characteristics by cohort
| Measure |
Ezetimibe
n=6 Participants
Participants take Ezetimibe 10mg daily for 3 months. N= 6 Ezetimibe: 10mg tablet
|
Simvastatin
n=6 Participants
Participants take Simvastatin 20mg daily for 3 months. N=6 Simvastatin: 20mg tablet
|
Vytorin
n=6 Participants
Participants take Vytorin 20/10mg daily for 3 months. N=6 Vytorin: 20/10mg tablet
|
Placebo
n=6 Participants
Participants take Placebo tab 1 daily for 3 months. N=6 Placebo: 1 tablet
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
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
|
|
Age, Continuous
|
53.3 years
STANDARD_DEVIATION 4.61 • n=5 Participants
|
49.5 years
STANDARD_DEVIATION 7.71 • n=7 Participants
|
52.8 years
STANDARD_DEVIATION 4.22 • n=5 Participants
|
52 years
STANDARD_DEVIATION 9.01 • n=4 Participants
|
52 years
STANDARD_DEVIATION 6.27 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
24 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 0 months, at the startPopulation: all participants assigned to Ezetimibe, Simvastatin, Vytorin and Placebo will receive the corresponding treatment according to the assigned group.
Patient's blood samples were collected before treatment. L5 were purified by ultracentrifugation then FPLC. Quantification analysis will indicate the L5 concentration (mg/dL) per group.
Outcome measures
| Measure |
Ezetimibe
n=6 Participants
Participants take Ezetimibe 10mg daily for 3 months. N= 6
|
Simvastatin
n=6 Participants
Participants take Simvastatin 20mg daily for 3 months. N=6
|
Vytorin
n=6 Participants
Participants take Vytorin 20/10mg daily for 3 months. N=6
|
Placebo
n=6 Participants
Participants take Placebo tab 1 daily for 3 months. N=6
|
|---|---|---|---|---|
|
L5 Concentration in Metabolic Syndrome Patients
|
35.97 mg/dL
Standard Deviation 28.87
|
17.8233 mg/dL
Standard Deviation 14.4558
|
29.736 mg/dL
Standard Deviation 21.143
|
23.1 mg/dL
Standard Deviation 18.338
|
SECONDARY outcome
Timeframe: 3 monthsPatient's blood samples were collected at the corresponding time point for L5 purification. L5 quantification and characterization were investigated with chemical analysis, proteomics and in-vitro cell signaling analysis. Final data analysis will determine total L5 concentration (mg/dL).
Outcome measures
| Measure |
Ezetimibe
n=6 Participants
Participants take Ezetimibe 10mg daily for 3 months. N= 6
|
Simvastatin
n=6 Participants
Participants take Simvastatin 20mg daily for 3 months. N=6
|
Vytorin
n=6 Participants
Participants take Vytorin 20/10mg daily for 3 months. N=6
|
Placebo
n=6 Participants
Participants take Placebo tab 1 daily for 3 months. N=6
|
|---|---|---|---|---|
|
L5 Concentration After Treatment of Ezetimibe, Simvastatin, or Vytorin in Metabolic Syndrome Patients
|
30.17 mg/dL
Standard Deviation 21.66
|
19.19 mg/dL
Standard Deviation 19.4648
|
14.17 mg/dL
Standard Deviation 16.721
|
15.15 mg/dL
Standard Deviation 15.027
|
Adverse Events
Ezetimibe
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Simvastatin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vytorin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ezetimibe
n=6 participants at risk
Participants take Ezetimibe 10mg daily for 3 months. N= 6
|
Simvastatin
n=6 participants at risk
Participants take Simvastatin 20mg daily for 3 months. N=6
|
Vytorin
n=6 participants at risk
Participants take Vytorin 20/10mg daily for 3 months. N=6
|
Placebo
n=6 participants at risk
Participants take Placebo tab 1 daily for 3 months. N=6
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
statin-associated muscle symptoms
|
0.00%
0/6 • 3 months later
After 3 months treatment, all participants went through systematic review of any serious adverse events (such as stain-associated muscle symptoms), other adverse events, and all-cause mortality.
|
0.00%
0/6 • 3 months later
After 3 months treatment, all participants went through systematic review of any serious adverse events (such as stain-associated muscle symptoms), other adverse events, and all-cause mortality.
|
0.00%
0/6 • 3 months later
After 3 months treatment, all participants went through systematic review of any serious adverse events (such as stain-associated muscle symptoms), other adverse events, and all-cause mortality.
|
0.00%
0/6 • 3 months later
After 3 months treatment, all participants went through systematic review of any serious adverse events (such as stain-associated muscle symptoms), other adverse events, and all-cause mortality.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place