Simvastatin With or Without Ezetimibe and Atherothrombotic Biomarker Assessment

NCT00819403 | Completed Phase 4 Results

• 2 other identifiers: HP-00040970MSP-JV IISP #32031
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

Brief Summary

To determine whether the combination of ezetimibe and simvastatin improves biomarkers of atherothrombosis compared to simvastatin alone in patients with the metabolic syndrome.

Conditions

Metabolic Syndrome

Keywords

triglycerides; hypertension; low hdl; obesity

Outcome Measures

Primary Outcomes (1)

• Ex Vivo Effects of Treatment With Vytorin Versus Zocor for 6 Weeks on Platelet Alpha Thrombin PAR-1 Receptor Expression

  Measured using whole blood flow cytometry

  6 weeks

Secondary Outcomes (1)

• Biomarkers of Inflammation

  6 weeks

Study Arms (2)

simvastatin

ACTIVE COMPARATOR

Simvastatin 40 mg daily

Drug: simvastatin

simvastatin/ezetimibe

ACTIVE COMPARATOR

Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.

Drug: ezetimibe/simvastatin

Interventions

simvastatin DRUG

Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.

Also known as: zocor

simvastatin

ezetimibe/simvastatin DRUG

Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.

Also known as: vytorin

simvastatin/ezetimibe

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women greater than or equal to 21 years of age
• Diagnosis of metabolic syndrome. We defined the presence of metabolic syndrome based on the US National Cholesterol Education Program's Adult Treatment Panel III guidelines. Specifically, metabolic syndrome will be diagnosed and documented when 3 of the following 5 characteristics will be present:
• abdominal obesity, given as waist circumference for men \> 102 cm, and for women \> 88 cm
• triglycerides \> 150 mg/dL
• HDL cholesterol \< 40 mg/dL for men, and \< 50 mg/dL for women
• blood pressure \> 130/85 mm Hg
• fasting glucose \> 100 mg/dL

You may not qualify if:

• Patients will be excluded for a history of bleeding diathesis
• drug or alcohol abuse
• prothrombin time greater than 1.5 times control
• platelet count \< 100,000/mm3
• hematocrit \< 25%
• creatinine \> 4.0 mg/dl
• surgery or angioplasty performed within 3 months or planned for the future
• history of gastrointestinal or other bleeding
• history of drug-induced disorders
• trauma, cancer, rheumatic diseases, coronary artery disease or stroke
• Patients participating in other investigational drug trials within one month of completion will be also excluded
• Patients treated with intravenous platelet glycoprotein IIb/IIIa inhibitors or thienopyridines, within past 6 months
• Patients treated with statins or aspirin within past four weeks

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (3)

VA Maryland Health Care System

Baltimore, Maryland, 21201, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21202, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Hypertension; Obesity

Interventions

Simvastatin; Ezetimibe, Simvastatin Drug Combination

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr Michael Miller
• Organization: Univ Maryland

mmiller@medicine.umaryland.edu

410 328-6299

Study Officials

• MICHAEL MILLER, MD

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

• VICTOR L. Serebruany, MD, PhD

  President, HeartDrug Research LLC

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 7, 2009
• First Posted: January 9, 2009
• Study Start: January 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: January 14, 2020
• Results First Posted: December 18, 2014

Record last verified: 2020-01

Locations

US (3)