Efficacy of Ezetimibe/Simvastatin 10/20 mg and MK0524A (1-2 g/Day) in Mixed Hyperlipidemia and Two or More Risk Factors

NCT00738985 | Withdrawn Phase 4

• 1 other identifier: 2008_019
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To measure the percentage of patients who achieve all the treatment lipid goals being treated with ezetimibe/simvastatin 10/20 with or without MK0524A (1-2 g/day).

Conditions

Cardiovascular Diseases; Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Lipid parameters efficacy comparing ezetimibe/simvastatin alone vs. ezetimibe/simvastatin plus MK0524A (CORDAPTIVE)

  18 Week(s)

Study Arms (2)

ezetimibe/simvastatin 10/20 mg + placebo

PLACEBO COMPARATOR

The intervention consisted of an isocaloric diet, an exercise program (30 min/day of aerobic activity) and ezetimibe (+) simvastatin 10/20 mg + placebo for 12 weeks. Safety and efficacy parameters are measured at baseline and 12 weeks later

Drug: ezetimibe/simvastatin 10/20 mg + placebo

ezetimibe/simvastatin 10/20 mg + MK0524A

ACTIVE COMPARATOR

The intervention consisted of an isocaloric diet, an exercise program (30 min/day of aerobic activity) and ezetimibe/simvastatin 10/20 mg + MK0524A 1 gr for 6 weeks, if efficacy achieved will continue with ezetimibe (+) simvastatin 10/20 mg + MK0524A 1 gr + placebo; if not achieved, will receive ezetimibe (+) simvastatin 10/20 mg + MK0524A 2 gr for 6 weeks.

Drug: ezetimibe/simvastatin 10/20 mg + MK0524A

Interventions

ezetimibe/simvastatin 10/20 mg + placebo DRUG

Patients will receive placebo (sugar tablets) for up to 22 weeks.

Also known as: No other drug is used per protocol in this study arm

ezetimibe/simvastatin 10/20 mg + placebo

ezetimibe/simvastatin 10/20 mg + MK0524A DRUG

ezetimibe (+) simvastatin 10/20 mg for 18 weeks. Tablets

Also known as: Vytorin, MK0653A

ezetimibe/simvastatin 10/20 mg + MK0524A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient Without Ischemic Cardiovascular Disease Who During The Treatment With Statin Have LDL-C \<130 Mg/Dl at Visit 1 Or Within The 6 Month Period Before Visit 1

You may not qualify if:

• The use of any other lipid lowering agent
• Life expectancy lower than a year.
• Any condition that may interfere with the adherence to the study protocol

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead
• Merck Sharp & Dohme LLC: collaborator

MeSH Terms

Conditions

Cardiovascular Diseases; Hyperlipidemias

Interventions

Ezetimibe; Simvastatin; Ezetimibe, Simvastatin Drug Combination

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 19, 2008
• First Posted: August 21, 2008
• Study Start: November 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: March 24, 2015

Record last verified: 2015-03