Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia (P05457)(COMPLETED) - Full Text View

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00653523

Purpose

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	Intervention	Phase
Hypercholesterolemia	Drug: Ezetimibe Drug: Simvastatin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Statins

Drug Information available for: Simvastatin Ezetimibe

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Number of Participants With Adverse Events and Adverse Reactions [ Time Frame: Throughout 1 year of study ] [ Designated as safety issue: Yes ]
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.

Enrollment:	151
Study Start Date:	December 2007
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
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

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00653523 History of Changes
Other Study ID Numbers:	P05457
Study First Received:	April 1, 2008
Results First Received:	May 27, 2010
Last Updated:	August 12, 2010
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Ezetimibe
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012