A Study to Evaluate an Investigational Drug in Patients With Mixed Hyperlipidemia (0653A-071)(COMPLETED)

NCT00093899 | Completed Phase 3

• 2 other identifiers: 0653A-0712004_044
• Study Type: interventional
• Target: 611
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the cholesterol lowering effects of an investigational drug in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).

Conditions

Hyperlipidemia; Hypercholesterolemia; Hypertriglyceridemia

Keywords

Mixed Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Plasma LDL-C.

Secondary Outcomes (1)

• Plasma HDL-C, non-HDL-C, and TG. Tolerability

Interventions

ezetimibe (+) simvastatin DRUG

Duration of Treatment: 6 months

Also known as: MK0653A

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women 18-79 years of age with high cholesterol and high triglycerides.

You may not qualify if:

• Individuals who do not meet specific cholesterol or triglyceride levels as required by the study.

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (3)

• Farnier M, Roth E, Gil-Extremera B, Mendez GF, Macdonell G, Hamlin C, Perevozskaya I, Davies MJ, Kush D, Mitchel YB; Ezetimibe/Simvastatin + Fenofibrate Study Group. Efficacy and safety of the coadministration of ezetimibe/simvastatin with fenofibrate in patients with mixed hyperlipidemia. Am Heart J. 2007 Feb;153(2):335.e1-8. doi: 10.1016/j.ahj.2006.10.031.

  PMID: 17239698 BACKGROUND

• Farnier M, Perevozskaya I, Taggart WV, Kush D, Mitchel YB. VAP II analysis of lipoprotein subclasses in mixed hyperlipidemic patients on treatment with ezetimibe/simvastatin and fenofibrate. J Lipid Res. 2008 Dec;49(12):2641-7. doi: 10.1194/jlr.P800034-JLR200. Epub 2008 Jul 31.

  PMID: 18669979 BACKGROUND

• Gil-Extremera B, Mendez G, Zakson M, Meehan A, Shah A, Lin J, Mitchel Y. Efficacy and safety of ezetimibe/simvastatin co- administered with fenofibrate in mixed hyperlipidemic patients with metabolic syndrome. Metab Syndr Relat Disord. 2007 Dec;5(4):305-14. doi: 10.1089/met.2007.0011.

  PMID: 18370800 BACKGROUND

MeSH Terms

Conditions

Hyperlipidemias; Hypercholesterolemia; Hypertriglyceridemia; Hyperlipoproteinemia Type II

Interventions

Ezetimibe, Simvastatin Drug Combination

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias

Intervention Hierarchy (Ancestors)

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

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2004
• First Posted: October 8, 2004
• Study Start: November 1, 2004
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: August 15, 2024

Record last verified: 2022-02