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

NCT00079846 | Terminated Phase 2

• 1 other identifier: MRL 2002-001
• Study Type: interventional
• Target: 60
• Locations: 5 countries
• Sites: 6

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).

Conditions

Familial Hypercholesterolemia

Keywords

Homozygous Familial Hypercholesterolemia (HoFH)

Interventions

Implitapide DRUG

Eligibility Criteria

• Age: 8 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical Research Laboratories International: lead

Study Sites (6)

Metabolic and Atherosclerosis Research Center

Cincinnati, Ohio, 45229, United States

Location

Lipid Clinic and Community Genomic Center, Complexe Hospitalier de la Sagamie

Chicoutimi, Quebec, G7H 5H6, Canada

Location

Lipid Research Center, CHUL du CHUQ

Sainte-Foy, Quebec, G1V 4G2, Canada

Location

Hadassah University Hospital

Jerusalem, 91120, Israel

Location

Academic Medical Center Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

Lipidklinikken - Rikshospitalet

Oslo, N-0027, Norway

Location

MeSH Terms

Conditions

Hyperlipoproteinemia Type II; Homozygous Familial Hypercholesterolemia

Interventions

implitapide

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 17, 2004
• First Posted: March 18, 2004
• Study Start: September 1, 2003
• Study Completion: April 1, 2005
• Last Updated: June 24, 2005

Record last verified: 2005-04

Locations

NL (1); IL (1); CA (2); US (1); NO (1)