Implitapide in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy
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ClinicalTrials.gov Identifier: NCT00079859 |
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 : | 120 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 Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy |
Study Start Date : | October 2003 |
Study Completion Date : | April 2005 |


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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
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 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

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): NCT00079859
United States, Ohio | |
Metabolic and Atherosclerosis Research Center | |
Cincinnati, Ohio, United States, 45229 | |
Netherlands | |
Andromed Leiden | |
Leiden, Netherlands | |
Andromed Rotterdam | |
Rotterdam, Netherlands | |
Andromed Oost | |
Velp, Netherlands | |
Andromed Zoetermeer | |
Zoetermeer, Netherlands | |
Norway | |
Lipidklinikken - Rikshospitalet | |
Oslo, Norway |
ClinicalTrials.gov Identifier: | NCT00079859 History of Changes |
Other Study ID Numbers: |
MRL 2002-002 |
First Posted: | March 18, 2004 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | April 2005 |
Keywords provided by Medical Research Laboratories International:
Heterozygous Familial Hypercholesterolemia (HeFH) |
Additional relevant MeSH terms:
Hypercholesterolemia Hyperlipoproteinemia Type II Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders |
Metabolic Diseases Lipid Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Hyperlipoproteinemias |