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Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00479388
First Posted: May 28, 2007
Last Update Posted: March 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12 [ Time Frame: Baseline and 12 Weeks ]

Secondary Outcome Measures:
  • Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12 [ Time Frame: Baseline and 12 Weeks ]
  • Percent Change From Baseline in Triglycerides at Week 12 [ Time Frame: Baseline and 12 Weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00479388


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00479388     History of Changes
Other Study ID Numbers: 0524A-067
2007_521
First Submitted: May 24, 2007
First Posted: May 28, 2007
Results First Submitted: June 9, 2009
Results First Posted: July 31, 2009
Last Update Posted: March 10, 2015
Last Verified: February 2015

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