Phase 4 N=24 Randomized Double-blind Treatment

Effects of Ezetimibe, Simvastatin, and Vytorin on Reducing L5 a Subfraction of LDL in Patients With Metabolic Syndrome.

Metabolic Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00988364 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2023

Primary outcome: Primary: L5 Concentration in Metabolic Syndrome Patients — 35.97; 17.8233; 29.736; 23.1 mg/dL

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Simvastatin (Drug); Vytorin (Drug); Placebo (Drug); Ezetimibe (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Baylor College of Medicine
Primary completion: Feb 2008

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	—

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.

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

View full record on ClinicalTrials.gov →

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.