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

Medical Research Laboratories International

Status and phase

Terminated

Phase 2

Conditions

Familial Hypercholesterolemia

Treatments

Drug: Implitapide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00079846

MRL 2002-001

Details and patient eligibility

About

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).

Sex

All

Ages

8 to 70 years old

Volunteers

No Healthy Volunteers

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.