Effects of Ezetimibe With Simvastatin in the Therapy of Adolescents With HeFH (Study P02579)(COMPLETED)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia |
Drug: ezetimibe with simvastatin Drug: simvastatin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
- Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: baseline to 6 weeks ] [ Designated as safety issue: No ]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
- Percent Change From Baseline in Total Cholesterol (TC) [ Time Frame: baseline to 6 weeks ] [ Designated as safety issue: No ]
- Percent Change From Baseline in Non High-density Lipoprotein Cholesterol (Non HDL-C) [ Time Frame: baseline to 6 weeks ] [ Designated as safety issue: No ]
- Percent Change From Baseline in Triglycerides (TG) [ Time Frame: baseline to 6 weeks ] [ Designated as safety issue: No ]
- Percent Change From Baseline in Apolipoprotein B (Apo B) [ Time Frame: baseline to 6 weeks ] [ Designated as safety issue: No ]
- Percent Change From Baseline in HDL-C [ Time Frame: baseline to 6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 248 |
| Study Start Date: | August 2005 |
| Study Completion Date: | June 2007 |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 10 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided by Schering-Plough
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00129402 History of Changes |
| Other Study ID Numbers: | P02579, EUDRACT NUMBER:2004-002627-40;, SCH 58235;, DOC ID 2526810 |
| Study First Received: | August 9, 2005 |
| Results First Received: | January 14, 2010 |
| Last Updated: | March 17, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Schering-Plough:
|
cholesterol drugs hypercholesterolemia adolescent randomized controlled trials |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipoproteinemia Type II Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Lipid Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Hyperlipoproteinemias Simvastatin |
Ezetimibe Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013