Implitapide in Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy
NCT ID: NCT00079846
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
60 participants
INTERVENTIONAL
2003-09-30
2005-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Interventions
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Implitapide
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
8 Years
70 Years
ALL
No
Sponsors
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Medical Research Laboratories International
INDUSTRY
Locations
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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
Countries
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Other Identifiers
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MRL 2002-001
Identifier Type: -
Identifier Source: org_study_id