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| Sponsors and Collaborators: |
In His Image Kos Pharmaceuticals |
|---|---|
| Information provided by: | In His Image |
| ClinicalTrials.gov Identifier: | NCT00345657 |
Purpose
The purpose of this study is to investigate the benefits of combination niacin ER/lovastatin in patients receiving standard care who are not at LDL goal per ATP III guidelines.
| Condition | Intervention | Phase |
|---|---|---|
|
Hyperlipidemia Mixed Hyperlipidemia Dyslipidemia |
Drug: Niacin Extended Release/Lovastatin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Extended-Release Niacin/Lovastatin Versus Usual Care for Treatment of Dyslipidemia in a Primary Care Setting (EXTEND Study) |
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2003 |
| Estimated Study Completion Date: | May 2004 |
Both LDL and HDL are important contributors in the pathophysiology of atherosclerosis and coronary artery disease (CAD); however, HDL is often ignored in primary care. The combination of niacin extended-release (ER)/lovastatin in a single tablet formulation (Advicor®) may be the most effective therapeutic option for simultaneously correcting both of these lipoprotein abnormalities to reduce CAD risk. The purpose of this study is to investigate the benefits of combination niacin ER/lovastatin in patients receiving standard care who are not at LDL goal per ATP III guidelines.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Oklahoma | |
| Family Medical Care of Tulsa | |
| Tulsa, Oklahoma, United States, 74136 | |
| Principal Investigator: | Jason A Logan, MD | In His Image Family Medicine Residency |
| Study Chair: | Edward Rylander, MD | In His Image Family Medicine Residency |
More Information
| Study ID Numbers: | IHI-A001 |
| Study First Received: | June 27, 2006 |
| Last Updated: | June 27, 2006 |
| ClinicalTrials.gov Identifier: | NCT00345657 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Hyperlipidemia Dyslipidemia Niacin |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Combination lipid therapy Lovastatin |
|
Antimetabolites Lipid Metabolism, Inborn Errors Vasodilator Agents Vitamin B Complex Hyperlipidemias Metabolic Diseases Niacinamide Antilipemic Agents Trace Elements Anticholesteremic Agents Cardiovascular Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Metabolism, Inborn Errors Nicotinic Acids Combined Hyperlipidemia, Familial Genetic Diseases, Inborn Vitamins Hyperlipidemia, Familial Combined Micronutrients Metabolic Disorder Niacin Lovastatin Dyslipidemias Lipid Metabolism Disorders |
|
Lipid Metabolism, Inborn Errors Antimetabolites Vasodilator Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Metabolism, Inborn Errors Therapeutic Uses Vitamins Micronutrients Lovastatin Dyslipidemias Metabolic Diseases Hyperlipidemias |
Vitamin B Complex Antilipemic Agents Growth Substances Enzyme Inhibitors Cardiovascular Agents Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Genetic Diseases, Inborn Hyperlipidemia, Familial Combined Niacin Lipid Metabolism Disorders |
