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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00479388
First received: May 24, 2007
Last updated: February 19, 2014
Last verified: February 2014
  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:


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 ] [ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
Publications:
Additional 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
Study First Received: May 24, 2007
Results First Received: June 9, 2009
Last Updated: February 19, 2014
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on October 23, 2014