Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia (P05457)

Open-label, Long-term Study of Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia Who Have Not Reached LDL-cholesterol Target With HMG-CoA Reductase Inhibitors

Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and simvastatin in patients with hypercholesterolemia who have not reached low density lipoprotein (LDL)-cholesterol target with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: Ezetimibe; Drug: Simvastatin

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with hypercholesterolemia who satisfy the following criteria:

  • Patients who have used any of the following HMG-CoA reductase inhibitors (hereinafter referred to as "statins") for 4 weeks or longer before the start of the observation period and whose LDL-cholesterol level during the treatment had not reached lipid management target indicated below
  • Age: 20 years of age or older (at the time of obtaining informed consent)
  • Sex: both males and females
  • Inpatient/outpatient: Out-patients

Exclusion Criteria:

• Patients for whom any of the following is applicable:

  • Patients whose fasted triglyceride level measured at the start of the observation period or the treatment period exceeds 500 mg/dL
  • Patients with homozygous familial hypercholesterolemia
  • Patients with creatine phosphokinase (CPK) > 2x upper limit of normal (ULN) measured at the start of the observation period or the treatment period.
  • Patients with serious hepatic disorder, or patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2x ULN measured at the start of the observation period or the treatment period.
  • Patients with a history of hypersensitivity to any ingredient of ezetimibe tablets or simvastatin tablets
  • Pregnant, nursing women, women who may be pregnant, or patients wishing to be pregnant during the study.
  • Patients who have discontinued use of serum lipid lowering agents for less than 4 weeks at the start of the treatment period (8 weeks in the case of probucol). (However, if the patient had taken a serum lipid lowering agent before the test conducted at the start of the observation period, a period of discontinuation of 27 days, or 55 days in the case of probucol, is allowed.)
  • Patients who are using cyclosporine from after the start of the observation period
  • Patients who are using any of the following drug from after the start of the observation period: itraconazole, miconazole, atazanavir, saquinavir mesilate
  • Patients with a history of ezetimibe use

  • Patients with hyperlipidemia associated with the following diseases:

    • Hypothyroidism
    • Obstructive gall bladder or biliary disease
    • Chronic renal failure
    • Pancreatitis
  • Patients with hyperlipidemia associated with concomitant use of drugs having adverse effect on serum lipids, etc
  • Patients who have received an investigational drug within 4 weeks of the start of the observation period
  • Other patients deemed not appropriate for study entry by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ezetimibe + Simvastatin; Ezetimibe 10 mg + Simvastatin 20 mg	Drug: Ezetimibe; Ezetimibe 10 mg once daily; Other Names: SCH 58235; Drug: Simvastatin; Simvastatin 20 mg daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events and Adverse Reactions	An adverse event is any unfavorable medical event occurring in a subject to whom an investigational product is administered, and a causal relationship between the administered investigational product and an adverse event is not always clarified. That is, an adverse event is any unfavorable or unintended sign (including an abnormal change in laboratory test values), symptom, or disease, and a causal relationship to the relevant investigational product is not considered. Any adverse event that was treatment-related was considered an adverse reaction.	Throughout 1 year of study

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2007
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: April 1, 2008
• First Submitted That Met QC Criteria: April 1, 2008
• First Posted (Estimated): April 7, 2008

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin; Ezetimibe
• Other Study ID Numbers: P05457

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD 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