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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00738985
• Other study ID #: 2008_019
• Status: Withdrawn
• Phase: Phase 4
• First received: August 19, 2008
• Last updated: March 23, 2015
• Start date: November 2009
• Est. completion date: September 2010

Study information

• Verified date: March 2015
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Description:

Patients will receive placebo for 4 weeks, then Vytorin 10/20 mg for 6 weeks, if efficacy of treatment is achieved, they will continue with Vytorin 10/20 mg + placebo for 12 more weeks, if not achieved, will receive Vytorin 10/20 mg + MK0524A 1 gr for 6 weeks, if efficacy achieved will continue with Vytorin 10/20 mg + MK0524A 1 gr + placebo; if not achieved, will receive Vytorin 10/20 mg + MK0524A 2 gr for 6 weeks.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hyperlipidemia
• Hyperlipidemia, Familial Combined
• Hyperlipidemias

Intervention

Drug:
• ezetimibe/simvastatin 10/20 mg + placebo
Patients will receive placebo (sugar tablets) for up to 22 weeks.
• ezetimibe/simvastatin 10/20 mg + MK0524A
ezetimibe (+) simvastatin 10/20 mg for 18 weeks. Tablets

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipid parameters efficacy comparing ezetimibe/simvastatin alone vs. ezetimibe/simvastatin plus MK0524A (CORDAPTIVE)		18 Week(s)	No