You are viewing an expired study

This study is not currently recruiting Study Participants on If you would like to find active studies please browse nearby listings below.

Click here to view additional nearby studies or search for clinical trials.

Cincinnati, Ohio 45229

  • Familial Hypercholesterolemia


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 heterozygous familial hypercholesterolemia (HeFH).


Inclusion Criteria: In order to participate in this study, patients must meet all of the following inclusion criteria: - be between 18 and 70 years old with a diagnosis of HeFH; - 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 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; - serum creatinine 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; - 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



Primary Contact:


Backup Contact:


Location Contact:

Cincinnati, Ohio 45229
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source:

Date Processed: March 26, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on The form below is not enabled.