A Study of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia (MK0653-139)

NCT00783263 | Completed Phase 3 Results

• 2 other identifiers: 0653-1392008_567
• Study Type: interventional
• Target: 440
• Locations: 0 countries
• Sites: N/A

Brief Summary

A study to evaluate the low-density lipoprotein cholesterol (LDL-C) lowering efficacy of the addition of ezetimibe to rosuvastatin compared with doubling dose of rosuvastatin in participants treated with rosuvastatin alone and not at their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) LDL-C goal

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment

  The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment in participants who were administered ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.

  Baseline to 6 weeks

Secondary Outcomes (6)

• Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum

  Baseline to 6 weeks

• Number of Participants Who Reached Their Target LDL-C Level

  6 weeks of treatment

• Number of Participants in Each Stratum Who Reached Their Target LDL-C Level

  6 weeks of treatment

• Number of Participants Who Reached the LDL-C Level of <70 mg/dl

  6 weeks of treatment

• Number of Participants in Each Stratum Who Reached the LDL-C Level of <70 mg/dl

  6 weeks of treatment

Study Arms (4)

Rosuvastatin 5 mg + Ezetimibe 10 mg

EXPERIMENTAL

Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.

Drug: Comparator: rosuvastatin 5 mg + ezetimibe 10 mg

Rosuvastatin 10 mg

ACTIVE COMPARATOR

Participants who received rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.

Drug: Comparator: rosuvastatin 10 mg

Rosuvastatin 10 mg + Ezetimibe 10 mg

EXPERIMENTAL

Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.

Drug: Comparator: rosuvastatin 10 mg + ezetimibe 10 mg

Rosuvastatin 20 mg

ACTIVE COMPARATOR

Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.

Drug: Comparator: rosuvastatin 20 mg

Interventions

Comparator: rosuvastatin 5 mg + ezetimibe 10 mg DRUG

Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.

Also known as: Crestor, Zetia

Rosuvastatin 5 mg + Ezetimibe 10 mg

Comparator: rosuvastatin 10 mg DRUG

Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.

Also known as: Crestor

Rosuvastatin 10 mg

Comparator: rosuvastatin 10 mg + ezetimibe 10 mg DRUG

Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.

Also known as: Crestor, Zetia

Rosuvastatin 10 mg + Ezetimibe 10 mg

Comparator: rosuvastatin 20 mg DRUG

Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.

Also known as: Crestor

Rosuvastatin 20 mg

Eligibility Criteria

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

You may qualify if:

• Participant is currently taking a stable dose of lipid lowering agent(s). (if applicable) or is statin naive
• Participant is currently taking a stable dose of lipid lowering agent(s). (if is at least moderate high risk for Coronary Heart Disease (CHD))
• Participant is currently taking a stable dose of lipid lowering agent(s). (if is willing to maintain Therapeutic Lifestyle Changes (TLC) / American Diabetes Association(ADA) diet)

You may not qualify if:

• Participant weighs less than 100 lbs (45 kg).
• Participant has hypersensitivity or intolerance to ezetimibe, or rosuvastatin or any components of these medications.
• If female, participant is pregnant or breastfeeding.
• Participant consumes more than 2 alcoholic beverages per day.
• Participant has been in a clinical trial within the last 30 days.
• Participant has heart problems such as CHF, unstable angina or heart attack.
• Participant has type 1 or 2 diabetes and has changed their medication in the last 2 months.
• Participant has liver disease.
• Participant is Human Immunodeficiency Virus (HIV) positive.
• Participant has a history of drug or alcohol abuse in the last year.

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Bays HE, Davidson MH, Massaad R, Flaim D, Lowe RS, Tershakovec AM, Jones-Burton C. Safety and efficacy of ezetimibe added on to rosuvastatin 5 or 10 mg versus up-titration of rosuvastatin in patients with hypercholesterolemia (the ACTE Study). Am J Cardiol. 2011 Aug 15;108(4):523-30. doi: 10.1016/j.amjcard.2011.03.079. Epub 2011 May 17.

  PMID: 21596364 RESULT

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Ezetimibe; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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 30, 2008
• First Posted: October 31, 2008
• Study Start: November 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 14, 2024
• Results First Posted: September 14, 2011

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share