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

• ClinicalTrials.gov Identifier: NCT00653523
• Recruitment Status: Completed
• First Posted: April 7, 2008
• Results First Posted: June 30, 2010
• Last Update Posted: May 10, 2017
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Hypercholesterolemia	Drug: Ezetimibe; Drug: Simvastatin	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 151 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: December 1, 2007
• Actual Primary Completion Date: June 1, 2009
• Actual Study Completion Date: June 1, 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ezetimibe + Simvastatin; Ezetimibe 10 mg + Simvastatin 20 mg	Drug: Ezetimibe; Ezetimibe 10 mg once daily; Other Name: SCH 58235; Drug: Simvastatin; Simvastatin 20 mg daily

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Adverse Events and Adverse Reactions [ Time Frame: Throughout 1 year of study ]

   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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT00653523
• Other Study ID Numbers: P05457
• First Posted: April 7, 2008
• Results First Posted: June 30, 2010
• 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; Simvastatin; Ezetimibe; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors