Implitapide in Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy
Stopped early · Phase 2
Conditions studied: Familial Hypercholesterolemia
In brief
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).
Key facts
- Study ID
- NCT00079846
- Run by
- Medical Research Laboratories International
- People needed
- 60
- Starts
- 2003-09-01
- Expected to finish
- 2005-04-01
- Last updated by the study team
- 2005-06-24
Who can join
Age: 8 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Metabolic and Atherosclerosis Research Center — Cincinnati, Ohio, United States
- Lipid Clinic and Community Genomic Center, Complexe Hospitalier de la Sagamie — Chicoutimi, Quebec, Canada
- Lipid Research Center, CHUL du CHUQ — Sainte-Foy, Quebec, Canada
- Hadassah University Hospital — Jerusalem, Israel
- Academic Medical Center Amsterdam — Amsterdam, Netherlands
- Lipidklinikken - Rikshospitalet — Oslo, Norway
Full record on ClinicalTrials.gov
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