Implitapide in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy - Full Text View

Purpose

The purpose of this study is to determine if implitapide, used in conjunction with other lipid-lowering therapies, is safe and effective when compared to placebo in lowering low-density lipoprotein cholesterol (LDL-C) in patients with heterozygous familial hypercholesterolemia (HeFH).

Condition	Intervention	Phase
Familial Hypercholesterolemia	Drug: Implitapide	Phase II

Genetics Home Reference related topics:

cholesteryl ester storage disease Farber lipogranulomatosis hypercholesterolemia long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency mitochondrial trifunctional protein deficiency primary carnitine deficiency

MedlinePlus related topics:

Cholesterol

Drug Information available for:

Lipids Implitapide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	Safety and Efficacy Study of Implitapide Compared With Placebo in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy

Further study details as provided by Medical Research Laboratories International:

Estimated Enrollment:	120
Study Start Date:	October 2003
Estimated Study Completion Date:	April 2005

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

In order to participate in this study, patients must meet all of the following inclusion criteria:

be between 18 and 70 years old with a diagnosis of HeFH;
be stable on and maintain concomitant therapy with hypolipidemic drugs or treatments;
have an appropriate calculated, fasting LDL-C levels and an appropriate triglyceride (TG) level;
be male or nonpregnant, nonlactating female;
give informed consent; and
meet body weight requirements.

Exclusion Criteria:

In order to participate in this study, patients must not meet any of the following exclusion criteria:

recent myocardial infarction, percutaneous transluminal coronary intervention, coronary artery bypass graft surgery, or cerebrovascular accident;
uncontrolled hypothyroidism or other uncontrolled endocrine disease;
known, clinically significant eye abnormalities (e.g., cataracts);
appropriate serum creatinine phosphokinase levels;
history of liver disease or liver enzyme levels above appropriate levels;
alkaline phosphatase above appropriate levels;
serum creatinine above appropriate levels;
liver cirrhosis and severe liver steatosis;
clinically significant infection, malignancy, or psychosis;
use of oral anticoagulants or digoxin, unless the dose has been stable for 4 weeks;
participation in any other investigational study, including device or observational studies, within 30 days;
lactating or have a positive serum pregnancy test;
current drug or alcohol abuse; or
unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the investigator

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079859

Locations


United States, Ohio
	Metabolic and Atherosclerosis Research Center
	Cincinnati, Ohio, United States, 45229

Netherlands
	Andromed Oost
	Velp, Netherlands
	Andromed Rotterdam
	Rotterdam, Netherlands
	Andromed Leiden
	Leiden, Netherlands
	Andromed Zoetermeer
	Zoetermeer, Netherlands

Norway
	Lipidklinikken - Rikshospitalet
	Oslo, Norway

Sponsors and Collaborators

Medical Research Laboratories International

More Information

Study ID Numbers:	MRL 2002-002
First Received:	March 17, 2004
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00079859
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medical Research Laboratories International:

Heterozygous Familial Hypercholesterolemia (HeFH)

Study placed in the following topic categories:

Lipid Metabolism, Inborn Errors

Hypercholesterolemia, autosomal dominant

Metabolism, Inborn Errors

Metabolic Diseases

Hyperlipidemias

Genetic Diseases, Inborn

Hyperlipoproteinemia Type II

Metabolic disorder

Hypercholesterolemia

Dyslipidemias

Hyperlipoproteinemias

Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Medical Research Laboratories International
Information provided by:	Medical Research Laboratories International
ClinicalTrials.gov Identifier:	NCT00079859