Implitapide in Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy
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ClinicalTrials.gov Identifier: NCT00079846 |
Recruitment Status :
Terminated
First Posted : March 18, 2004
Last Update Posted : June 24, 2005
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Familial Hypercholesterolemia | Drug: Implitapide | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Safety and Efficacy Study of Implitapide Compared With Placebo in Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy |
Study Start Date : | September 2003 |
Study Completion Date : | April 2005 |


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Ages Eligible for Study: | 8 Years to 70 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00079846
United States, Ohio | |
Metabolic and Atherosclerosis Research Center | |
Cincinnati, Ohio, United States, 45229 | |
Canada, Quebec | |
Lipid Clinic and Community Genomic Center, Complexe Hospitalier de la Sagamie | |
Chicoutimi, Quebec, Canada, G7H 5H6 | |
Lipid Research Center, CHUL du CHUQ | |
Sainte-Foy, Quebec, Canada, G1V 4G2 | |
Israel | |
Hadassah University Hospital | |
Jerusalem, Israel, 91120 | |
Netherlands | |
Academic Medical Center Amsterdam | |
Amsterdam, Netherlands, 1105 AZ | |
Norway | |
Lipidklinikken - Rikshospitalet | |
Oslo, Norway, N-0027 |
ClinicalTrials.gov Identifier: | NCT00079846 |
Other Study ID Numbers: |
MRL 2002-001 |
First Posted: | March 18, 2004 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | April 2005 |
Homozygous Familial Hypercholesterolemia (HoFH) |
Hyperlipoproteinemia Type II Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders |
Metabolic Diseases Lipid Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Hyperlipoproteinemias |