Coadministration of Ezetimibe and Atorvastatin in Patients With Primary Hypercholesterolemia (P05456)(COMPLETED) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00654095

Purpose

Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and atorvastatin in patients with hypercholesterolemia who have not reached LDL-cholesterol target with HMG-CoA reductase inhibitors.

Condition	Intervention	Phase
Hypercholesterolemia	Drug: Ezetimibe Drug: atorvastatin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Open-label, Long-term Study of Coadministration of Ezetimibe and Atorvastatin 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: Atorvastatin Atorvastatin calcium Ezetimibe

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Adverse events and adverse reactions [ Time Frame: Throughout 1 year of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Laboratory test results and vital signs [ Time Frame: Throughout 1 year of study ] [ Designated as safety issue: Yes ]
% change in LDL-cholesterol from before the start of treatment to the end of treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Proportion of patients showing an LDL-cholesterol value reaching the lipid management target [ Time Frame: Throughout 1 year of study ] [ Designated as safety issue: No ]
% change in serum lipids, serum lipoproteins, and hs-CRP [ Time Frame: Throughout 1 year of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	140
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
Ezetimibe + Atorvastatin: Experimental Ezetimibe 10 mg + Atorvastatin 20 mg	Drug: Ezetimibe Ezetimibe 10 mg once daily Drug: atorvastatin atorvastatin 20 mg once 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
- Age: 20 years of age or older (at the time of obtaining informed consent)
- Sex: both males and females
- Inpatient/outpatient: Out-patient

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 CPK > 2x ULN measured at the start of the observation period or the treatment period.
- Patients with serious hepatic disorder, or patients with ALT or 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 atorvastatin 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 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:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P05456
Study First Received:	April 1, 2008
Last Updated:	July 29, 2009
ClinicalTrials.gov Identifier:	NCT00654095 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Antimetabolites
Metabolic Diseases
Hyperlipidemias
Antilipemic Agents
Ezetimibe
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Metabolic Disorder
Hypercholesterolemia
Atorvastatin
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Ezetimibe
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on September 09, 2009