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| Sponsor: | Kos Pharmaceuticals |
|---|---|
| Information provided by: | Kos Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00079638 |
Purpose
The purpose of this study is to evaluate the effectiveness of first-line treatment using Niaspan (an extended release version of niacin) and statins versus other drugs that lower lipid levels, in subjects with elevated fat levels in their blood (dyslipidemia). Statins are a class of medication that is often prescribed to patients who need to lower their cholesterol levels.
| Condition | Intervention | Phase |
|---|---|---|
|
Dyslipidemia Coronary Heart Disease Atherosclerosis Stroke Diabetes |
Drug: Niacin Drug: Atorvastatin Drug: Simvastatin Drug: Ezetimibe Drug: Rosuvastatin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparative Efficacy Evaluation of Lipid Levels When Treated With Niaspan and Statin or Other Lipid-Modifying Therapies |
| Estimated Enrollment: | 300 |
| Study Start Date: | April 2004 |
| Estimated Study Completion Date: | May 2005 |
Name of Drugs: Niaspan (niacin extended-release tablets), Lipitor® (atorvastatin), Zocor® (simvastatin), Zetia™ (ezetimibe), and Crestor® (rosuvastatin)
Study Treatment: Four open-label parallel treatment groups for 12 weeks of observation
Objective: To evaluate the relative efficacy of first-line therapy using the combination of Niaspan and atorvastatin versus the combination of simvastatin and ezetimibe versus rosuvastatin monotherapy versus the combination of Niaspan and rosuvastatin in patients with dyslipidemia.
Population:
Design: A Phase IV, 12-week, randomized, multi-center, open-label, four-arm, parallel-group study evaluating the efficacy of Niaspan and statin therapy versus other lipid-modifying therapies preceded by a four-week washout of any previous lipid-lowering therapy.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All of the following criteria must be answered “Yes”:
Exclusion Criteria:
All the following criteria must be answered “No”:
Patient has a history of any of the following:
Patient has any of the following abnormalities at any of the Screening or Qualification Visits:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00079638 History of Changes |
| Other Study ID Numbers: | 001-09-03-CR, COMPELL |
| Study First Received: | March 10, 2004 |
| Last Updated: | October 31, 2006 |
| Health Authority: | United States: Food and Drug Administration |
|
Niaspan Niacin Statin Cholesterol Triglycerides Lipid-Modifying Therapies Dyslipidemia Coronary Heart Disease Atherosclerosis |
Stroke VA-HIT Niacin Statin Combination Threrapy High Density Lipoprotein Low Density Lipoprotein Hypertension Diabetes Adult Treatment Panel III |
|
Atherosclerosis Coronary Artery Disease Myocardial Ischemia Coronary Disease Diabetes Mellitus Heart Diseases Stroke Dyslipidemias Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Lipid Metabolism Disorders Niacin Simvastatin Atorvastatin Rosuvastatin Ezetimibe Hydroxymethylglutaryl-CoA Reductase Inhibitors Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |