Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)
Primary Purpose
Primary Hypercholesterolemia, Mixed Dyslipidemia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Comparator: simvastatin
niacin (+) laropiprant
Comparator: atorvastatin calcium
Sponsored by
About this trial
This is an interventional treatment trial for Primary Hypercholesterolemia
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
1
2
Arm Description
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.
Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
Outcomes
Primary Outcome Measures
Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12
Secondary Outcome Measures
Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12
Percent Change From Baseline in Triglycerides at Week 12
Full Information
NCT ID
NCT00479388
First Posted
May 24, 2007
Last Updated
February 20, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00479388
Brief Title
Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypercholesterolemia, Mixed Dyslipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1216 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
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.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Comparator: simvastatin
Other Intervention Name(s)
Zocor®
Intervention Description
simvastatin (20mg to 40mg) for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
niacin (+) laropiprant
Other Intervention Name(s)
MK0524A
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Comparator: atorvastatin calcium
Other Intervention Name(s)
atorvastatin
Intervention Description
atorvastatin calcium (20mg to 40mg) for 12 weeks.
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12
Time Frame
Baseline and 12 Weeks
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12
Time Frame
Baseline and 12 Weeks
Title
Percent Change From Baseline in Triglycerides at Week 12
Time Frame
Baseline and 12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
20518948
Citation
Shah S, Ceska R, Gil-Extremera B, Paolini JF, Giezek H, Vandormael K, Mao A, McCrary Sisk C, Maccubbin D. Efficacy and safety of extended-release niacin/laropiprant plus statin vs. doubling the dose of statin in patients with primary hypercholesterolaemia or mixed dyslipidaemia. Int J Clin Pract. 2010 May;64(6):727-38. doi: 10.1111/j.1742-1241.2010.02370.x.
Results Reference
result
PubMed Identifier
22500948
Citation
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.
Results Reference
derived
PubMed Identifier
21401833
Citation
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. doi: 10.1111/j.1742-1241.2010.02620.x.
Results Reference
derived
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Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)
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