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Sponsored by: |
Medical Research Laboratories International |
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Information provided by: | Medical Research Laboratories International |
ClinicalTrials.gov Identifier: | NCT00079859 |
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).
Condition | Intervention | Phase |
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Familial Hypercholesterolemia |
Drug: Implitapide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy Study of Implitapide Compared With Placebo in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
In order to participate in this study, patients must meet all of the following inclusion criteria:
Exclusion Criteria:
In order to participate in this study, patients must not meet any of the following exclusion criteria:
United States, Ohio | |
Metabolic and Atherosclerosis Research Center | |
Cincinnati, Ohio, United States, 45229 | |
Netherlands | |
Andromed Oost | |
Velp, Netherlands | |
Andromed Rotterdam | |
Rotterdam, Netherlands | |
Andromed Leiden | |
Leiden, Netherlands | |
Andromed Zoetermeer | |
Zoetermeer, Netherlands | |
Norway | |
Lipidklinikken - Rikshospitalet | |
Oslo, Norway |
Study ID Numbers: | MRL 2002-002 |
Study First Received: | March 17, 2004 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00079859 |
Health Authority: | United States: Food and Drug Administration |
Heterozygous Familial Hypercholesterolemia (HeFH) |
Lipid Metabolism, Inborn Errors Hypercholesterolemia, autosomal dominant Metabolism, Inborn Errors Metabolic Diseases Hyperlipidemias Genetic Diseases, Inborn |
Hyperlipoproteinemia Type II Metabolic disorder Hypercholesterolemia Dyslipidemias Hyperlipoproteinemias Lipid Metabolism Disorders |