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| Sponsor: | Medical Research Laboratories International |
|---|---|
| Information provided by: | Medical Research Laboratories International |
| ClinicalTrials.gov Identifier: | NCT00080132 |
Purpose
The purpose of this study is to determine if implitapide is effective in lowering triglyceride (TG) levels in patients with Fredrickson Type I or V hypertriglyceridemia where the maximum tolerable medication and diet were not sufficient.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertriglyceridemia |
Drug: implitapide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Safety/Efficacy Study |
| Official Title: | An Open-Label, Dose-Escalating Efficacy and Safety Study of Implitapide in Patients With Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-Lowering Therapy |
Eligibility| Ages Eligible for Study: | 8 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:
Contacts and Locations| United States, Ohio | |
| Metabolic and Atherosclerosis Research Center | |
| Cincinnati, Ohio, United States, 45229 | |
| United States, Texas | |
| The Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| Netherlands | |
| Andromed Noord | |
| Groningen, Netherlands, 9711 SG | |
| Andromed Oost | |
| Velp, Netherlands, 6883 HM | |
| Andromed Rotterdam | |
| Rotterdam, Netherlands, 3021 HC | |
| Andromed Leiden | |
| Leiden, Netherlands, 2311 GZ | |
| Andromed Zoetermeer | |
| Zoetermeer, Netherlands, 2724 EK | |
| Academic Medical Center Amsterdam | |
| Amsterdam, Netherlands, 1105 AZ | |
| Norway | |
| Lipidklinikken - Rikshospitalet | |
| Oslo, Norway | |
More Information
| Study ID Numbers: | MRL 2002-003 |
| Study First Received: | March 23, 2004 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00080132 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HTG Hypertriglyceridemia, Fredrickson Type I Hypertriglyceridemia, Fredrickson Type V |
|
Metabolic Diseases Hyperlipidemias Hypertriglyceridemia Dyslipidemias Lipid Metabolism Disorders |