Phase 4
Completed N=24
Effects of Ezetimibe, Simvastatin, and Vytorin on Reducing L5 a Subfraction of LDL in Patients With Metabolic Syndrome.
Source: ClinicalTrials.gov NCT00988364 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcomePrimary: L5 Concentration in Metabolic Syndrome Patients — 35.97; 17.8233; 29.736; 23.1 mg/dL
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is:
* To identify the common factor for L5 prevalence in patients with Metabolic Syndrome.
* To determine whether Ezetimibe, Simvastatin, and Vytorin can correct the L5- promoting factor and reduce L5 in Metabolic Syndrome patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY L5 Concentration in Metabolic Syndrome Patients |
35.97; 17.8233; 29.736; 23.1 | — |
| SECONDARY L5 Concentration After Treatment of Ezetimibe, Simvastatin, or Vytorin in Metabolic Syndrome Patients |
30.17; 19.19; 14.17; 15.15 | — |
Eligibility Criteria
Inclusion Criteria
- Participants who meet 3 or more of the 5 criteria specified in the ATPIII guidelines will be recruited.
- The 5 criteria are:
- abdominal obesity (men>40 inches, women >35 inches);
- TG> 150mg/dL;
- low HDL-C (men or=130/>or=85 mmHg);
- fasting glucose > or = 110mg/dL.
- People with different ethnic backgrounds will be included.
Exclusion Criteria
- symptomatic coronary artery disease
- peripheral vascular disease
- cerebral ischemia (stroke)
- smoking
- hypothyroidism
- kidney diseases
- consumption of antioxidation supplements/drugs or use of lipid-lowering drugs in the last 3 months
- women who are pregnant, nursing, or planning to become pregnant
Data sourced from ClinicalTrials.gov (NCT00988364). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.