Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients With Dyslipidemia: A Dose-Ranging Study - SEACOAST

This study has been completed.
Sponsor:
Information provided by:
Kos Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00082251
First received: May 3, 2004
Last updated: October 31, 2006
Last verified: October 2006
  Purpose

The purpose of this study is to compare the effectiveness and safety of different doses of Niacin ER/Simvastatin (NS), in subjects with elevated fat levels in their blood (dyslipidemia).


Condition Intervention Phase
Hypercholesterolemia
Drug: Niacin extended release and simvastatin tablets
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients With Dyslipidemia: A Dose-Ranging Study - SEACOAST

Resource links provided by NLM:


Further study details as provided by Kos Pharmaceuticals:

Detailed Description:

The purpose of this study is to compare the efficacy and safety of different doses of Niacin ER/Simvastatin (NS), in subjects with elevated fat levels in their blood (dyslipidemia).

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has primary Type II hyperlipidemia or mixed dyslipidemia
  • If the patient is currently taking anti-dyslipidemic medications other than Zocor, he/she is willing to withdraw from these medications
  • Reasonable compliance with a standard cholesterol-lowering diet for a minimum of 4 weeks prior to screening and for the duration of the study.
  • LDL-C levels and/or Non HDL-C levels above normal for patients

This study will be conducted both in the USA and internationally.

Exclusion Criteria:

  • Patient has an allergy, hypersensitivity, or intolerance to niacin, statins, or their derivatives
  • HbA1c ≥ 9% in diabetic patients
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00082251     History of Changes
Other Study ID Numbers: 019-01-03-CR, SEACOAST
Study First Received: May 3, 2004
Last Updated: October 31, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Kos Pharmaceuticals:
Dyslipidemia
High Blood Cholesterol
Coronary Heart Disease
Hypertension
National Cholesterol Education Program
Adult Treatment Panel III
Niacin
Simvastatin
Diabetes
Peripheral Vascular Disease
Cerebrovascular disease
Stroke
High-Density Lipoprotein Cholesterol
Hydroxymethyl Glutaryl Coenzyme A
High-Sensitivity C-Reactive Protein
Low-Density Lipoprotein Cholesterol
Lipoprotein (a)
Lipoprotein A-I
Total Cholesterol
Triglycerides

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Niacin
Simvastatin
Nicotinic Acids
Niacinamide
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014