Trial | NCT00079846  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    60
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).
Study Started
Sep 30
2003
Study Completion
Apr 30
2005
Last Update
Jun 24
2005
Estimate

Drug Implitapide

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.
No Results Posted