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

NCT00653523 | Completed Phase 3 Results

• 1 other identifier: P05457
• Study Type: interventional
• Target: 151
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Ezetimibe + Simvastatin

EXPERIMENTAL

Ezetimibe 10 mg + Simvastatin 20 mg

Drug: Ezetimibe; Drug: Simvastatin

Interventions

Ezetimibe DRUG

Ezetimibe 10 mg once daily

Also known as: SCH 58235

Ezetimibe + Simvastatin

Simvastatin DRUG

Simvastatin 20 mg daily

Ezetimibe + Simvastatin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Ezetimibe; Simvastatin

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 7, 2008
• Study Start: December 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: May 21, 2024
• Results First Posted: June 30, 2010

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share