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

NCT00988364 | Completed Phase 4 Results DMC

• 2 other identifiers: H-20169MK0653A
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Syndrome

Keywords

Metabolic Syndrome; LDL subfraction L5; The reduction of LDL in patients with Metabolic Syndrome; The prevalence of L5 in patients with Metabolic Syndrome; The reduction of L5 in patients with Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• L5 Concentration in Metabolic Syndrome Patients

  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.

  0 months, at the start

Secondary Outcomes (1)

• L5 Concentration After Treatment of Ezetimibe, Simvastatin, or Vytorin in Metabolic Syndrome Patients

  3 months

Study Arms (4)

Ezetimibe

ACTIVE COMPARATOR

Randomly chosen participants will receive ezetimibe 10mg daily for 3 months.

Drug: Ezetimibe

Simvastatin

ACTIVE COMPARATOR

Randomly chosen participants will receive Simvastatin 20mg daily for 3 months.

Drug: Simvastatin

Vytorin

ACTIVE COMPARATOR

Randomly chosen participants will receive Vytorin 20/10mg daily for 3 months.

Drug: Vytorin

Placebo

PLACEBO COMPARATOR

Randomly chosen participants will receive Placebo tab 1 daily for 3 months.

Drug: Placebo

Interventions

Simvastatin DRUG

Simvastatin 20mg daily for 3 months.

Also known as: Zocor

Simvastatin

Vytorin DRUG

Vytorin 20/10mg daily for 3 months.

Also known as: Ezetimibe/Simvastatin

Vytorin

Placebo DRUG

Placebo one tablet daily times 3 months.

Also known as: Control

Placebo

Ezetimibe DRUG

Ezetimibe 10mg daily for 3 months.

Also known as: Zetia

Ezetimibe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \< 40mg/dL, women \< 50 mg/dL);
• high blood pressure (\>or=130/\>or=85 mmHg);
• fasting glucose \> or = 110mg/dL.
• People with different ethnic backgrounds will be included.

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (20)

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MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Simvastatin; Ezetimibe, Simvastatin Drug Combination; Ezetimibe

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Chu-Huang Chen
• Organization: Baylor College of Medicine

chu-huang.chen@bcm.edu

832-355-9026

Study Officials

• Chu-Huang Chen, M.D., Ph.D.

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Christie Ballantyne, M.D.

  Baylor College of Medicine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, placebo-controlled clinical trial with 4 arms

Study Record Dates

• First Submitted: October 1, 2009
• First Posted: October 2, 2009
• Study Start: March 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: November 30, 2023
• Results First Posted: November 30, 2023

Record last verified: 2023-11

Locations

US (1)