Implitapide in Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy

Study Description

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Brief Summary:

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 homozygous familial hypercholesterolemia (HoFH).

Condition or disease	Intervention/treatment	Phase
Familial Hypercholesterolemia	Drug: Implitapide	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	Safety and Efficacy Study of Implitapide Compared With Placebo in Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy
Study Start Date :	September 2003
Study Completion Date :	April 2005

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Ages Eligible for Study:	8 Years to 70 Years (Child, Adult, Senior)
Sexes Eligible for Study:	All
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 8 and 70 years old with a diagnosis of HoFH;
• 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 and height 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;
• 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;
• history of or 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Ohio
Metabolic and Atherosclerosis Research Center
Cincinnati, Ohio, United States, 45229
Canada, Quebec
Lipid Clinic and Community Genomic Center, Complexe Hospitalier de la Sagamie
Chicoutimi, Quebec, Canada, G7H 5H6
Lipid Research Center, CHUL du CHUQ
Sainte-Foy, Quebec, Canada, G1V 4G2
Israel
Hadassah University Hospital
Jerusalem, Israel, 91120
Netherlands
Academic Medical Center Amsterdam
Amsterdam, Netherlands, 1105 AZ
Norway
Lipidklinikken - Rikshospitalet
Oslo, Norway, N-0027

Sponsors and Collaborators

Medical Research Laboratories International

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00079846 History of Changes
Other Study ID Numbers:	MRL 2002-001
First Posted:	March 18, 2004
Last Update Posted:	June 24, 2005
Last Verified:	April 2005

Keywords provided by Medical Research Laboratories International:

Homozygous Familial Hypercholesterolemia (HoFH)

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