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Effects of Ezetimibe With Simvastatin in the Therapy of Adolescents With HeFH (Study P02579)

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ClinicalTrials.gov Identifier: NCT00129402
Recruitment Status : Completed
First Posted : August 11, 2005
Results First Posted : February 11, 2010
Last Update Posted : September 21, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This is a randomized, double-blind, controlled, parallel-group, multicenter, Phase-3 study to evaluate the efficacy and safety of ezetimibe with simvastatin taken alone in subjects ages 10-17 years with Heterozygous Familial Hypercholesterolemia.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: ezetimibe with simvastatin Drug: simvastatin Phase 3

Detailed Description:

This study consisted of 3 distinct periods. In Period 1, subjects received daily treatment for 6 weeks as part of either the ezetimibe with simvastatin group or part of the simvastatin monotherapy group. Subjects in the ezetimibe with simvastatin group received one of three treatments: coadministration of ezetimibe 10 mg/day plus simvastatin 10 mg/day, 20 mg/day, or 40 mg/day. Subjects in the simvastatin monotherapy group received one of three treatments: ezetimibe placebo plus simvastatin 10 mg/day, 20 mg/day, or 40 mg/day. The primary and key secondary efficacy analysis were based on the evaluations performed during Period 1 and were presented as data for subjects pooled from either the ezetimibe with simvastatin treatment groups compared with data for subjects pooled from the simvastatin monotherapy treatment groups.

In Period 2, subjects received ezetimibe 10 mg/day plus simvastatin 40 mg/day or ezetimibe placebo plus simvastatin 40 mg/day for 27 additional weeks maintaining the same treatment assignment (coadministration vs monotherapy) as in Period 1.

In Period 3, all subjects received ezetimibe 10 mg/day plus open-label simvastatin daily for 20 weeks.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy, Safety, and Tolerability of Ezetimibe in Coadministration With Simvastatin in the Therapy of Adolescents With Heterozygous Familial Hypercholesterolemia
Study Start Date : August 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007


Arm Intervention/treatment
Experimental: Pooled subjects who received ezetimibe with simvastatin
Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
Drug: ezetimibe with simvastatin
Ezetimibe 10 mg plus simvastatin 10 mg once a day for six weeks, or Ezetimibe 10 mg plus simvastatin 20 mg once a day for six weeks, or Ezetimibe 10 mg plus simvastatin 40 mg once a day for six weeks

Active Comparator: Pooled subjects who received simvastatin monotherapy
Pooled subjects who received ezetimibe matching placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
Drug: simvastatin
Ezetimibe matching placebo plus simvastatin 10 mg once a day for six weeks, or Ezetimibe matching placebo plus simvastatin 20 mg once a day for six weeks, or Ezetimibe matching placebo plus simvastatin 40 mg once a day for six weeks




Primary Outcome Measures :
  1. Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: baseline to 6 weeks ]
    Least squares mean percent change from Baseline in LDL-C at the end of Step 1 (Week 6) in the pooled groups who received ezetimibe plus simvastatin compared with pooled groups who received simvastatin monotherapy


Secondary Outcome Measures :
  1. Percent Change From Baseline in Total Cholesterol (TC) [ Time Frame: baseline to 6 weeks ]
  2. Percent Change From Baseline in Non High-density Lipoprotein Cholesterol (Non HDL-C) [ Time Frame: baseline to 6 weeks ]
  3. Percent Change From Baseline in Triglycerides (TG) [ Time Frame: baseline to 6 weeks ]
  4. Percent Change From Baseline in Apolipoprotein B (Apo B) [ Time Frame: baseline to 6 weeks ]
  5. Percent Change From Baseline in HDL-C [ Time Frame: baseline to 6 weeks ]


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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adolescent (ages 10 - 17 years) boys or girls weighing at least 88 lbs (40 kg).
  • Subjects must have high cholesterol (low density lipoprotein cholesterol [LDL-C] more than 159 mg/dL or 4.1 mmol/L) and a family history of high cholesterol.

Exclusion Criteria:

  • Subjects diagnosed with delayed puberty.
  • Subjects who are sensitive to simvastatin and/or ezetimibe.
  • Subjects who drink alcohol excessively or who have a history of alcohol or drug abuse within the past 2 years.
  • Subjects who are known to be HIV positive, are undergoing LDL apheresis or plasma apheresis, or have had a partial ileal bypass.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00129402     History of Changes
Other Study ID Numbers: P02579
EUDRACT NUMBER:2004-002627-40;
SCH 58235;
DOC ID 2526810
First Posted: August 11, 2005    Key Record Dates
Results First Posted: February 11, 2010
Last Update Posted: September 21, 2015
Last Verified: September 2015

Keywords provided by Merck Sharp & Dohme Corp.:
cholesterol
drugs
hypercholesterolemia
adolescent
randomized controlled trials

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