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

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ClinicalTrials.gov Identifier: NCT00479388
Recruitment Status : Completed
First Posted : May 28, 2007
Results First Posted : July 31, 2009
Last Update Posted : March 10, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Primary Hypercholesterolemia Mixed Dyslipidemia Drug: Comparator: simvastatin Drug: niacin (+) laropiprant Drug: Comparator: atorvastatin calcium Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1216 participants
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.
Study Start Date : July 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : October 2008


Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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

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.

Additional Information:
Publications of Results:
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 Posted: May 28, 2007    Key Record Dates
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