Anti-inflammatory Effects of Simvastatin

NCT04638400 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: STUDY00001035
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine which of the two ingredients of Vytorin (Simvastatin or Ezetimibe) is responsible for the anti-inflammatory effects of Vytorin

Conditions

Inflammation; Atherosclerosis; Hypercholesterolemia

Outcome Measures

Primary Outcomes (2)

• Change in mRNA Expression of CD68 in MNC

  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.

  6 weeks

• Change in mRNA Expression of PECAM on MNC

  Percentage 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.

  6 weeks

Secondary Outcomes (3)

• Change in mRNA Expression of IL-1β in MNC

  6 weeks

• Change in TNF-a mRNA Expression in MNC

  6 weeks

• Change in mRNA Expression of MMP-9 in MNC

  6 weeks

Study Arms (2)

Simvastatin

ACTIVE COMPARATOR

Obese subjects with elevated cholesterol

Drug: Simvastatin 40mg

Ezetimibe

ACTIVE COMPARATOR

Obese subjects with elevated cholesterol

Drug: Ezetimibe 10mg

Interventions

Simvastatin 40mg DRUG

Simvastatin administered daily for 6 weeks

Also known as: Simvastatin

Simvastatin

Ezetimibe 10mg DRUG

Ezetimibe administered daily for 6 weeks

Also known as: Zetia

Ezetimibe

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 to 75 years of age.
• Obese (BMI ≥30 kg/m2)
• LDL cholesterol of ≥100 mg/dl
• Not taking any vitamins or antioxidants

You may not qualify if:

• Currently using anti-hyperlipidemic therapies
• Triglycerides \>500 mg/dl.
• Myocardial infarction, angioplasty/stent placement or coronary artery bypass surgery in the past 6 months.
• Patient on chronic use of non-steroidal anti-inflammatory drugs or steroids
• Hepatic disease
• Renal impairment.
• History of drug or alcohol abuse
• Participation in any other concurrent clinical trial
• Use of an investigational agent or therapeutic regimen within 30 days of study.
• Smoker
• Pregnancy
• Premenopausal women who are not on birth control pills and have not had a hysterectomy or tubal ligation
• Anemia with hemoglobin \<12 g/dl

Sponsors & Collaborators

• paresh Dandona: lead

Study Sites (1)

Diabetes and Endocrinology Research Center of WNY

Buffalo, New York, 14221, United States

Location

MeSH Terms

Conditions

Inflammation; Atherosclerosis; Hypercholesterolemia

Interventions

Simvastatin; Ezetimibe

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid 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

Results Point of Contact

• Title: Dr. Paresh Dandona
• Organization: Division of Endocrinology, Diabetes and Metabolism, State University of New York at Buffalo, 462 Grider St, Buffalo, NY 14215, USA

pdandona@kaleidahealth.org

7169574325

Study Officials

• Paresh Dandona, MD, PhD

  Distinguished Professor of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Distinguished Professor of Medicine

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: November 20, 2020
• Study Start: May 1, 2017
• Primary Completion: August 1, 2021
• Study Completion: November 1, 2021
• Last Updated: November 8, 2024
• Results First Posted: January 23, 2024

Record last verified: 2024-10

Locations

US (1)