Implitapide in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy

Phase 2

Terminated

• Conditions: Familial Hypercholesterolemia

• Registration Number: NCT00079859
• Lead Sponsor: Medical Research Laboratories International

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 heterozygous familial hypercholesterolemia (HeFH).

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2004-03-17
• Study First Submitted QC: 2004-03-17
• Study First Posted: 2004-03-18
• Status Verified: 2005-04
• Study Completion: 2005-04
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (6)

Andromed Oost; 🇳🇱 Velp, Netherlands

Andromed Zoetermeer; 🇳🇱 Zoetermeer, Netherlands

Andromed Rotterdam; 🇳🇱 Rotterdam, Netherlands

Metabolic and Atherosclerosis Research Center; 🇺🇸 Cincinnati, Ohio, United States

Lipidklinikken - Rikshospitalet; 🇳🇴 Oslo, Norway

Andromed Leiden; 🇳🇱 Leiden, Netherlands