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

Familial Hypercholesterolemia Clinical Trial

Official title:

Safety and Efficacy Study of Implitapide Compared With Placebo in Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00079846
• Other study ID #: MRL 2002-001
• Status: Terminated
• Phase: Phase 2
• First received: March 17, 2004
• Last updated: June 23, 2005
• Start date: September 2003
• Est. completion date: April 2005

Study information

• Verified date: April 2005
• Source: Medical Research Laboratories International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

Intervention

Drug:
• Implitapide

Locations

Country	Name	City	State
Canada	Lipid Clinic and Community Genomic Center, Complexe Hospitalier de la Sagamie	Chicoutimi	Quebec
Canada	Lipid Research Center, CHUL du CHUQ	Sainte-Foy	Quebec
Israel	Hadassah University Hospital	Jerusalem
Netherlands	Academic Medical Center Amsterdam	Amsterdam
Norway	Lipidklinikken - Rikshospitalet	Oslo
United States	Metabolic and Atherosclerosis Research Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Laboratories International

Countries where clinical trial is conducted

United States,  Canada,  Israel,  Netherlands,  Norway,