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Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00871351
First Posted: March 30, 2009
Last Update Posted: May 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
The purpose of this study is to evaluate the efficacy and safety of atorvastatin 10 mg and ezetimibe 10 mg coadministration in Japanese participants with hypercholesterolemia whose low-density lipoprotein (LDL)-cholesterol levels have not reached the lipid management target value with atorvastatin 10 mg alone, versus increasing the dose of atorvastatin to 20 mg or changing to rosuvastatin 2.5 mg.

Condition Intervention Phase
Primary Hypercholesterolemia Drug: Ezetimibe Drug: Atorvastatin Drug: Rosuvastatin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ezetimibe Phase IV Clinical Study in Patients With Hypercholesterolemia

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percent Change in Low-Density Lipoprotein - Cholesterol (LDL-C) Values [ Time Frame: End of Week 4 to Week 16 or discontinuation ]
    LDL-C was measured before group study drug administration (Week 4, end of atorvastatin single therapy) and at the end of study drug administration (after 12 weeks of study drug treatment, or at discontinuation).


Secondary Outcome Measures:
  • Percent Change in LDL-C [ Time Frame: End of washout period to Week 16 or discontinuation ]
    LDL-C was measured at the start of the atorvastatin 10 mg treatment period (end of the washout period) and at the end of administration of the study drug (Week 16 or discontinuation).

  • Number of Participants Whose LDL-C Levels Reached the Lipid Management Target Values [ Time Frame: Week 16 or discontinuation ]

    LDL-C was measured at the end of administration of the study drug (Week 16 or discontinuation).

    Target values:

    For participants with history of coronary artery disease: <100 mg/dL;

    for participants with at least 3 cardiovascular (CV) risk factors: <120 mg/dL;

    for participants with 1-2 CV risk factors: <140 mg/dL;

    for participants with no CV risk factors: <160 mg/dL.


  • Percent Change in Total Lipids and High Sensitivity C-reactive Protein (Hs-CRP) [ Time Frame: End of Week 4 to Week 16 or discontinuation ]
    Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at 4 weeks after the start of the treatment period (after completion of administration of atorvastatin 10 mg alone) and at Week 16 or at discontinuation.

  • Percent Change in Total Lipids and Hs-CRP [ Time Frame: End of washout to Week 16 or discontinuation ]
    Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at the start of the treatment period (at start of administration of atorvastatin 10 mg alone) and at the end of study drug (Week 16 or discontinuation).


Enrollment: 125
Actual Study Start Date: February 1, 2009
Study Completion Date: May 1, 2010
Primary Completion Date: May 1, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ezetimibe + Atorvastatin
Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
Drug: Ezetimibe
1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)
Other Name: SCH 058235
Drug: Atorvastatin
1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)
Active Comparator: Atorvastatin
Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
Drug: Atorvastatin
2 tablets of 10 mg daily for 12 weeks (Weeks 5-16)
Active Comparator: Rosuvastatin
Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
Drug: Rosuvastatin
1 tablet of 2.5 mg daily for 12 weeks (Weeks 5-16)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • atorvastatin 10 mg monotherapy for 4 weeks or longer before the start of the 4-week washout and low density lipoprotein-cholesterol (LDL-C) levels that had not reached the following lipid management target values during treatment: Category I (low-risk group) with no other risk factors - LDL-C <160 mg/dL; Category II (mid-risk group) with 1-2 risk factors other than LDL-C levels - LDL-C <140 mg/dL; Category III (high-risk group) with 3 or more other risk factors - LDL-C <120 mg/dL; and for participants with history of coronary artery disease - LDL-C <100 mg/dL.
  • outpatient men or women, age 20 years and older

Exclusion Criteria:

  • fasted triglyceride level at the start of washout or treatment period exceeding 400 mg/dL.
  • homozygous familial hypercholesterolemia.
  • creatine phosphokinase (CPK) >2 times the upper limit of normal (X ULN) at start of washout or treatment period.
  • glycosylated hemoglobin (HbA1c) >=8% at start of washout or treatment period.
  • severe hepatic function disorder, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2X ULN at start of washout or treatment period.
  • hypersensitivity to ezetimibe, atorvastatin, or rosuvastatin tablets.
  • pregnant or lactating
  • discontinued use of atorvastatin 10 mg for less than 4 weeks at start of treatment period (however, if participant had taken atorvastatin 10 mg before the test conducted at the start of the observation period, a period of discontinuation of 27 days is allowed.)
  • cyclosporine treatment
  • hyperlipidemia associated with hypothyroidism, obstructive gall bladder or biliary disease, chronic renal failure, and/or pancreatitis.
  • hyperlipidemia associated with drug administration that causes adverse serum lipid effects.
  • participation in a clinical study within 4 weeks of washout
  • cancer or cancer history within previous 5 years, except for successfully treated basal cell carcinoma of the skin.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00871351     History of Changes
Other Study ID Numbers: P06027
First Submitted: March 26, 2009
First Posted: March 30, 2009
Results First Submitted: May 16, 2011
Results First Posted: August 23, 2011
Last Update Posted: May 10, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Rosuvastatin Calcium
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors