Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)(COMPLETED) - Full Text View

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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Calcium Cholesterol Statins

Drug Information available for: Niacin Niacinamide Calcium Gluconate Simvastatin Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12 [ Time Frame: Baseline and 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12 [ Time Frame: Baseline and 12 Weeks ] [ Designated as safety issue: Yes ]
Percent Change From Baseline in Triglycerides at Week 12 [ Time Frame: Baseline and 12 Weeks ] [ Designated as safety issue: No ]

Enrollment:	1216
Study Start Date:	July 2007
Study Completion Date:	October 2008
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. Other Name: MK0524A
Active Comparator: 2 Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.	Drug: Comparator: simvastatin simvastatin (20mg to 40mg) for 12 weeks. Other Name: Zocor® Drug: Comparator: atorvastatin calcium atorvastatin calcium (20mg to 40mg) for 12 weeks. Other Name: atorvastatin

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

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

No publications provided by Merck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bays HE, Shah A, Lin J, Sisk CM, Dong Q, Maccubbin D. Consistency of extended-release niacin/laropiprant effects on Lp(a), ApoB, non-HDL-C, Apo A1, and ApoB/ApoA1 ratio across patient subgroups. Am J Cardiovasc Drugs. 2012 Jun 1;12(3):197-206. doi: 10.2165/11631530-000000000-00000.

Bays H, Shah A, Dong Q, McCrary Sisk C, Maccubbin D. Extended-release niacin/laropiprant lipid-altering consistency across patient subgroups. Int J Clin Pract. 2011 Apr;65(4):436-45.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00479388 History of Changes
Other Study ID Numbers:	2007_521, MK0524A-067
Study First Received:	May 24, 2007
Results First Received:	June 9, 2009
Last Updated:	March 9, 2012
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Niacin
Simvastatin
Atorvastatin
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 May 23, 2013