Trial Outcomes & Findings for Anti-inflammatory Effects of Simvastatin (NCT NCT04638400)
NCT ID: NCT04638400
Last Updated: 2024-11-08
Results Overview
Percentage change in mRNA expression of CD68 in MNC following cream challenge at weeks 0 and 6 of treatment with simvastatin or ezetimibe. Percent change (using the formula: (x-y)/y\*100) is calculated using data collected before (0hr) and after the cream challenge (peak effect) at weeks 0 and 6 of treatment with simvastatin or ezetimibe.
TERMINATED
PHASE4
10 participants
6 weeks
2024-11-08
Participant Flow
Participant milestones
| Measure |
Simvastatin
Obese subjects with elevated cholesterol
Simvastatin 40mg: Simvastatin administered daily for 6 weeks
|
Ezetimibe
Obese subjects with elevated cholesterol
Ezetimibe 10mg: Ezetimibe administered daily for 6 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Simvastatin
n=5 Participants
Obese subjects with elevated cholesterol
Simvastatin 40mg: Simvastatin administered daily for 6 weeks
|
Ezetimibe
n=5 Participants
Obese subjects with elevated cholesterol
Ezetimibe 10mg: Ezetimibe administered daily for 6 weeks
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=10 Participants
|
|
Age, Continuous
|
53.2 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
53.2 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
53.2 years
STANDARD_DEVIATION 4.2 • n=10 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=10 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=10 Participants
|
|
Change in CD68 mRNA expression
|
48 Percent of Change
STANDARD_DEVIATION 11 • n=5 Participants
|
44.5 Percent of Change
STANDARD_DEVIATION 7 • n=5 Participants
|
46 Percent of Change
STANDARD_DEVIATION 9 • n=10 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPercentage change in mRNA expression of CD68 in MNC following cream challenge at weeks 0 and 6 of treatment with simvastatin or ezetimibe. Percent change (using the formula: (x-y)/y\*100) is calculated using data collected before (0hr) and after the cream challenge (peak effect) at weeks 0 and 6 of treatment with simvastatin or ezetimibe.
Outcome measures
| Measure |
Simvastatin
n=5 Participants
Obese subjects with elevated cholesterol
Simvastatin 40mg: Simvastatin administered daily for 6 weeks
|
Ezetimibe
n=5 Participants
Obese subjects with elevated cholesterol
Ezetimibe 10mg: Ezetimibe administered daily for 6 weeks
|
|---|---|---|
|
Change in mRNA Expression of CD68 in MNC
week 0
|
48 percentage change
Standard Error 11
|
44.5 percentage change
Standard Error 7
|
|
Change in mRNA Expression of CD68 in MNC
week 6
|
38 percentage change
Standard Error 9
|
35 percentage change
Standard Error 5
|
PRIMARY outcome
Timeframe: 6 weeksPercentage change in mRNA expression of PECAM on MNC following cream challenge before and after 6 weeks of treatment with simvastatin or ezetimibe. Percent change (using the formula: (x-y)/y\*100) was calculated using data collected before (0hr) and after the cream challenge (peak effect) at weeks 0 and 6 of treatment with simvastatin or ezetimibe.
Outcome measures
| Measure |
Simvastatin
n=5 Participants
Obese subjects with elevated cholesterol
Simvastatin 40mg: Simvastatin administered daily for 6 weeks
|
Ezetimibe
n=5 Participants
Obese subjects with elevated cholesterol
Ezetimibe 10mg: Ezetimibe administered daily for 6 weeks
|
|---|---|---|
|
Change in mRNA Expression of PECAM on MNC
week 0
|
38 percentage change
Standard Error 8
|
42 percentage change
Standard Error 6
|
|
Change in mRNA Expression of PECAM on MNC
week 6
|
36 percentage change
Standard Error 10
|
38 percentage change
Standard Error 8
|
SECONDARY outcome
Timeframe: 6 weeksPercentage change in mRNA expression of IL-1β in MNC following cream challenge calculated from data collected before (at 0 week) and after (at 6 weeks) treatment with simvastatin or ezetimibe
Outcome measures
| Measure |
Simvastatin
n=5 Participants
Obese subjects with elevated cholesterol
Simvastatin 40mg: Simvastatin administered daily for 6 weeks
|
Ezetimibe
n=5 Participants
Obese subjects with elevated cholesterol
Ezetimibe 10mg: Ezetimibe administered daily for 6 weeks
|
|---|---|---|
|
Change in mRNA Expression of IL-1β in MNC
week 0
|
41 percentage of change
Standard Error 15
|
38 percentage of change
Standard Error 11
|
|
Change in mRNA Expression of IL-1β in MNC
week6
|
36 percentage of change
Standard Error 7
|
40 percentage of change
Standard Error 12
|
SECONDARY outcome
Timeframe: 6 weeksPercentage change in mRNA expression of TNFα in MNC following cream challenge calculated using data collected before and after the cream challenge at weeks 0 and 6 of treatment with simvastatin or ezetimibe
Outcome measures
| Measure |
Simvastatin
n=5 Participants
Obese subjects with elevated cholesterol
Simvastatin 40mg: Simvastatin administered daily for 6 weeks
|
Ezetimibe
n=5 Participants
Obese subjects with elevated cholesterol
Ezetimibe 10mg: Ezetimibe administered daily for 6 weeks
|
|---|---|---|
|
Change in TNF-a mRNA Expression in MNC
week 0
|
48 percentage of change
Standard Error 17
|
43 percentage of change
Standard Error 9
|
|
Change in TNF-a mRNA Expression in MNC
week 6
|
41 percentage of change
Standard Error 13
|
38 percentage of change
Standard Error 6
|
SECONDARY outcome
Timeframe: 6 weeksPercentage change in mRNA expression of MMP-9 in MNC calculated from data collected following cream challenge before (0 week) and after (6 weeks) of treatment with simvastatin or ezetimibe
Outcome measures
| Measure |
Simvastatin
n=5 Participants
Obese subjects with elevated cholesterol
Simvastatin 40mg: Simvastatin administered daily for 6 weeks
|
Ezetimibe
n=5 Participants
Obese subjects with elevated cholesterol
Ezetimibe 10mg: Ezetimibe administered daily for 6 weeks
|
|---|---|---|
|
Change in mRNA Expression of MMP-9 in MNC
week 6
|
28 percentage of change
Standard Error 12
|
36 percentage of change
Standard Error 8
|
|
Change in mRNA Expression of MMP-9 in MNC
week 0
|
34 percentage of change
Standard Error 8
|
35 percentage of change
Standard Error 6
|
Adverse Events
Simvastatin
Ezetimibe
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Paresh Dandona
Division of Endocrinology, Diabetes and Metabolism, State University of New York at Buffalo, 462 Grider St, Buffalo, NY 14215, USA
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place