Study of Extended Release Niacin/Laropiprant on Lipids - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00479388

Purpose

This is a 12-Week clinical trial in patients with Primary hypercholesterolemia or mixed dyslipidemia to study the effects of ER niacin/laropiprant on lipids.

Condition	Intervention	Phase
Primary Hypercholesterolemia Mixed Dyslipidemia	Drug: Comparator: simvastatin Drug: niacin (+) laropiprant Drug: Comparator: atorvastatin calcium	Phase III

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Calcium Cholesterol

Drug Information available for: Niacin Simvastatin Niacinamide Atorvastatin Atorvastatin calcium Laropiprant Calcium gluconate Niacin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Parallel Group, 12 Week Study to Evaluate the Efficacy and Safety of Extended-Release (ER) Niacin/Laropiprant in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia.

Further study details as provided by Merck:

Primary Outcome Measures:

After 12 weeks of treatment, to assess the effect of ER niacin/laropiprant on plasma lipids [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

After 12 weeks of treatment, to assess the safety and tolerability of ER niacin/laropiprant [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: Yes ]

Enrollment:	1250
Study Start Date:	July 2007
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.	Drug: niacin (+) laropiprant One tablet of ER niacin/ laropiprant (1g); titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
2: Active Comparator Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.	Drug: Comparator: simvastatin simvastatin (20mg to 40mg) for 12 weeks. Drug: Comparator: atorvastatin calcium atorvastatin calcium (20mg to 40mg) for 12 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients 18 to 80 years of age with Primary hypercholesterolemia or mixed dyslipidemia
Patients will be eligible for the study if their LDL-C values are within protocol specified range and meet other entry criteria

Exclusion Criteria:

Patient whose LDL-C values are not within protocol specified range

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00479388

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

(MedWatch - FDA maintained medical product safety Information) This link exits the ClinicalTrials.gov site

(PhRMA Clinical Study Results Database - web-based repository for clinical study results) This link exits the ClinicalTrials.gov site

(Merck: Patient & Caregiver U.S. Product Web Site) This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_521, MK0524A-067
Study First Received:	May 24, 2007
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00479388 History of Changes
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Antimetabolites
Vasodilator Agents
Vitamin B Complex
Hyperlipidemias
Metabolic Diseases
Niacinamide
Simvastatin
Antilipemic Agents
Trace Elements
Anticholesteremic Agents
Cardiovascular Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Nicotinic Acids
Calcium, Dietary
Vitamins
Micronutrients
Hypercholesterolemia
Metabolic Disorder
Niacin
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Vasodilator Agents
Vitamin B Complex
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Growth Substances
Antilipemic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Anticholesteremic Agents

Cardiovascular Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Vitamins
Therapeutic Uses
Micronutrients
Hypercholesterolemia
Niacin
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009