Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED) - Full Text View

Sponsor:	Schering-Plough
Information provided by (Responsible Party):	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00704535

Purpose

The purpose of this study is to evaluate the overall safety, tolerability, and efficacy of Ezetimibe when used alone or in combination with a statin in patients with hypercholesterolemia

Condition	Intervention
Primary Hypercholesterolemia Homozygous Familial Hypercholesterolemia	Drug: Ezetimibe

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Ezetimibe Among Filipino Patients

Resource links provided by NLM:

Genetics Home Reference related topics: Chanarin-Dorfman syndrome cholesteryl ester storage disease Farber lipogranulomatosis hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Ezetimibe

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Safety as Measured by Number of Subjects With at Least One Adverse Event [ Time Frame: 28 days after Visit 1 ] [ Designated as safety issue: Yes ]
Evaluation of the overall safety of ezetimibe as measured by number of subjects who experienced at least one adverse event
Safety as Measured by Number and Type of Adverse Events. [ Time Frame: 28 days after Visit 1 ] [ Designated as safety issue: Yes ]
Evaluation of the overall safety of ezetimibe as measured by the number and type of adverse events.
Safety as Measured by Severity of Adverse Events as Determined by the Investigator [ Time Frame: 28 days after Visit 1 ] [ Designated as safety issue: Yes ]
To evaulate the safety of ezetimibe as measured by severity of adverse events, as determined by the investigator
Safety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator. [ Time Frame: 28 days after Visit 1 ] [ Designated as safety issue: Yes ]
To evaluate the overall safety of ezetimibe as measured by adverse event relatedness to study drug as reported by the investigator.
Safety as Measured by Dose Adjustment Upon Incidence of an Adverse Event [ Time Frame: 28 days after Visit 1 ] [ Designated as safety issue: Yes ]
To evaluate the overall safety of ezetimibe as measured by action taken by the investigator upon incidence of an adverse event
Safety as Measured by Outcome of Adverse Events [ Time Frame: 28 days after Visit 1 ] [ Designated as safety issue: Yes ]
To evaluate overall safety of ezetimibe as measured by outcome of adverse events
Tolerability as Measured by Subject Self-assessment [ Time Frame: 28 days after Visit 1 ] [ Designated as safety issue: No ]
Evaluation of the overall tolerability of ezetimibe as measured by subject self-assessment

Secondary Outcome Measures:

To Evaluate the Efficacy of Ezetimibe in Lowering Serum Cholesterol Levels 28 Days After Visit 1 (Baseline) [ Time Frame: 28 days after Visit 1 ] [ Designated as safety issue: No ]
Change in mean total cholesterol values

Enrollment:	4105
Study Start Date:	March 2006
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Subjects with hypercholesterolemia Subjects with hypercholesterolemia that are using Ezetimibe either alone or in combination with a statin	Drug: Ezetimibe 1 tablet of 10 mg once daily Other Name: SCH 58235

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Filipino subjects with hypercholesterolemia

Criteria

Inclusion Criteria:

Outpatient men or women, age 18 years and above.
Patients with primary (heterozygous familial and non-familial) hypercholesterolemia or homozygous familial hypercholesterolemia.

Exclusion Criteria:

Known hypersensitivity to Ezetimibe.
Moderate to severe hepatic insufficiency.
Persistent elevation of serum transaminase levels of more than 1.5 times the upper limit of normal.
Pregnancy or lactation.
Concomitant intake of bile acid sequestrants (resins), nicotinic acid (niacin), fibric acid (fibrates), or cyclosporine

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00704535 History of Changes
Other Study ID Numbers:	P04748
Study First Received:	June 23, 2008
Results First Received:	May 21, 2009
Last Updated:	October 20, 2011
Health Authority:	Philippines: Bureau of Food and Drugs

Additional relevant MeSH terms:

Hypercholesterolemia
Hyperlipoproteinemia Type II
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn

Hyperlipoproteinemias
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012