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Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients With High Cholesterol or Abnormal Lipid Levels (MK-0524A-133)

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ClinicalTrials.gov Identifier: NCT01274559
Recruitment Status : Terminated (In HPS2-THRIVE, MK-0524A did not meet the primary efficacy objective and there was a significant increase in incidence of some types of non-fatal SAEs)
First Posted : January 11, 2011
Results First Posted : March 14, 2014
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Primary Hypercholesterolemia
Mixed Dyslipidemia
Interventions Drug: Extended-release niacin/laropiprant (ERN/LRPT)
Drug: Placebo
Enrollment 1173

Recruitment Details  
Pre-assignment Details Phase 3 study HPS2-THRIVE (NCT00461630) did not meet its primary endpoint of reduction of major vascular events and had a significant increase in the incidence of some types of non-fatal serious adverse events. As a result, MK-0524A-133 was discontinued. Only individual data were obtained; none of the planned efficacy outcomes were summarized.
Arm/Group Title Extended-release Niacin/Laropiprant Placebo
Hide Arm/Group Description Extended-release niacin (ERN)/laropiprant (LRPT) 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant. Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
Period Title: Overall Study
Started 587 586
Treated 572 572
Completed 390 441
Not Completed 197 145
Reason Not Completed
Adverse Event             57             13
Death             1             1
Lost to Follow-up             3             3
Non-compliance with Study Drug             2             4
Physician Decision             2             1
Protocol Violation             28             23
Study Terminated by Sponsor             79             87
Withdrawal by Subject             25             13
Arm/Group Title Extended-release Niacin/Laropiprant Placebo Total
Hide Arm/Group Description ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant. Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks) Total of all reporting groups
Overall Number of Baseline Participants 587 586 1173
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 587 participants 586 participants 1173 participants
21 to 30 years 1 2 3
31 to 40 years 9 12 21
41 to 50 years 63 62 125
51 to 60 years 182 168 350
61 to 70 years 209 232 441
71 to 80 years 108 98 206
>80 years 15 12 27
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 587 participants 586 participants 1173 participants
Female
239
  40.7%
243
  41.5%
482
  41.1%
Male
348
  59.3%
343
  58.5%
691
  58.9%
1.Primary Outcome
Title Percent Change From Baseline at Week 12 in Low Density Lipoprotein-Cholesterol (LDL-C)
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Arm/Group Title Extended-release Niacin/Laropiprant Placebo
Hide Arm/Group Description:
ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Percent Change From Baseline in LDL-C:High-density Lipoprotein Cholesterol (HDL-C) at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Arm/Group Title Extended-release Niacin/Laropiprant Placebo
Hide Arm/Group Description:
ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Percent Change From Baseline in HDL-C at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Arm/Group Title Extended-release Niacin/Laropiprant Placebo
Hide Arm/Group Description:
ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Percent Change From Baseline in Triglyceride (TG) at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Arm/Group Title Extended-release Niacin/Laropiprant Placebo
Hide Arm/Group Description:
ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Percent Change From Baseline in Non-HDL-C at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Arm/Group Title Extended-release Niacin/Laropiprant Placebo
Hide Arm/Group Description:
ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Arm/Group Title Extended-release Niacin/Laropiprant Placebo
Hide Arm/Group Description:
ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Percent Change From Baseline in Apo B:Apolipoprotein A-I (Apo A-I) at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Arm/Group Title Extended-release Niacin/Laropiprant Placebo
Hide Arm/Group Description:
ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Percent Change From Baseline in Total Cholesterol (TC):HDL-C at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Arm/Group Title Extended-release Niacin/Laropiprant Placebo
Hide Arm/Group Description:
ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Arm/Group Title Extended-release Niacin/Laropiprant Placebo
Hide Arm/Group Description:
ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Percent Change From Baseline in Apo A-I at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Arm/Group Title Extended-release Niacin/Laropiprant Placebo
Hide Arm/Group Description:
ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Percent Change From Baseline in TC at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Arm/Group Title Extended-release Niacin/Laropiprant Placebo
Hide Arm/Group Description:
ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Percent Change From Baseline in LDL-C at Week 4
Hide Description [Not Specified]
Time Frame Baseline and Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Arm/Group Title Extended-release Niacin/Laropiprant Placebo
Hide Arm/Group Description:
ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Percent Change From Baseline in LDL-C:HDL-C at Week 4
Hide Description [Not Specified]
Time Frame Baseline and Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Arm/Group Title Extended-release Niacin/Laropiprant Placebo
Hide Arm/Group Description:
ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Percent Change From Baseline in HDL-C at Week 4
Hide Description [Not Specified]
Time Frame Baseline and Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Arm/Group Title Extended-release Niacin/Laropiprant Placebo
Hide Arm/Group Description:
ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Percent Change From Baseline in TG at Week 4
Hide Description [Not Specified]
Time Frame Baseline and Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Arm/Group Title Extended-release Niacin/Laropiprant Placebo
Hide Arm/Group Description:
ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Percent Change From Baseline in Non-HDL-C at Week 4
Hide Description [Not Specified]
Time Frame Baseline and Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Arm/Group Title Extended-release Niacin/Laropiprant Placebo
Hide Arm/Group Description:
ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title Percent Change From Baseline in Apo B at Week 4
Hide Description [Not Specified]
Time Frame Baseline and Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Arm/Group Title Extended-release Niacin/Laropiprant Placebo
Hide Arm/Group Description:
ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Secondary Outcome
Title Percent Change From Baseline in Apo B:Apo A-I at Week 4
Hide Description [Not Specified]
Time Frame Baseline and Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Arm/Group Title Extended-release Niacin/Laropiprant Placebo
Hide Arm/Group Description:
ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
19.Secondary Outcome
Title Percent Change From Baseline in TC:HDL-C at Week 4
Hide Description [Not Specified]
Time Frame Baseline and Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Arm/Group Title Extended-release Niacin/Laropiprant Placebo
Hide Arm/Group Description:
ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
20.Secondary Outcome
Title Percent Change From Baseline in Lp(a) at Week 4
Hide Description [Not Specified]
Time Frame Baseline and Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Arm/Group Title Extended-release Niacin/Laropiprant Placebo
Hide Arm/Group Description:
ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
21.Secondary Outcome
Title Percent Change From Baseline in Apo A-I at Week 4
Hide Description [Not Specified]
Time Frame Baseline and Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Arm/Group Title Extended-release Niacin/Laropiprant Placebo
Hide Arm/Group Description:
ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
22.Secondary Outcome
Title Percent Change From Baseline in TC at Week 4
Hide Description [Not Specified]
Time Frame Baseline and Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Arm/Group Title Extended-release Niacin/Laropiprant Placebo
Hide Arm/Group Description:
ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
23.Secondary Outcome
Title Number of Participants Who Achieve LDL-C Target Levels at Week 12 of Treatment
Hide Description assessed as per National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) and European Society of Cardiology (ESC) treatment guidelines
Time Frame Baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Arm/Group Title Extended-release Niacin/Laropiprant Placebo
Hide Arm/Group Description:
ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame up to 12 weeks
Adverse Event Reporting Description The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
 
Arm/Group Title Extended-release Niacin/Laropiprant Placebo
Hide Arm/Group Description ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant. Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
All-Cause Mortality
Extended-release Niacin/Laropiprant Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Extended-release Niacin/Laropiprant Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/572 (4.02%)      16/572 (2.80%)    
Cardiac disorders     
Angina unstable  1  1/572 (0.17%)  1 1/572 (0.17%)  1
Aortic valve stenosis  1  1/572 (0.17%)  1 0/572 (0.00%)  0
Atrial fibrillation  1  1/572 (0.17%)  1 0/572 (0.00%)  0
Bradycardia  1  1/572 (0.17%)  1 0/572 (0.00%)  0
Cardiac failure congestive  1  2/572 (0.35%)  2 0/572 (0.00%)  0
Cardiogenic shock  1  0/572 (0.00%)  0 1/572 (0.17%)  1
Coronary artery disease  1  1/572 (0.17%)  1 1/572 (0.17%)  1
Ear and labyrinth disorders     
Vertigo  1  1/572 (0.17%)  1 0/572 (0.00%)  0
Gastrointestinal disorders     
Constipation  1  0/572 (0.00%)  0 1/572 (0.17%)  1
General disorders     
Non-cardiac chest pain  1  1/572 (0.17%)  1 2/572 (0.35%)  2
Sudden cardiac death  1  1/572 (0.17%)  1 0/572 (0.00%)  0
Infections and infestations     
Epiglottitis  1  1/572 (0.17%)  1 0/572 (0.00%)  0
Gastroenteritis  1  1/572 (0.17%)  1 1/572 (0.17%)  1
Pneumonia  1  0/572 (0.00%)  0 1/572 (0.17%)  1
Puncture site infection  1  1/572 (0.17%)  1 0/572 (0.00%)  0
Injury, poisoning and procedural complications     
Contusion  1  1/572 (0.17%)  1 0/572 (0.00%)  0
Meniscus lesion  1  0/572 (0.00%)  0 1/572 (0.17%)  1
Metabolism and nutrition disorders     
Hypoglycaemia  1  1/572 (0.17%)  1 0/572 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  1/572 (0.17%)  1 0/572 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  0/572 (0.00%)  0 2/572 (0.35%)  2
Bile duct cancer  1  1/572 (0.17%)  1 0/572 (0.00%)  0
Malignant melanoma  1  0/572 (0.00%)  0 1/572 (0.17%)  1
Prostatic adenoma  1  1/572 (0.17%)  1 0/572 (0.00%)  0
Squamous cell carcinoma  1  1/572 (0.17%)  1 0/572 (0.00%)  0
Uterine leiomyoma  1  1/572 (0.17%)  1 0/572 (0.00%)  0
Nervous system disorders     
Cerebrovascular accident  1  2/572 (0.35%)  2 0/572 (0.00%)  0
Haemorrhage intracranial  1  0/572 (0.00%)  0 1/572 (0.17%)  1
Syncope  1  1/572 (0.17%)  1 0/572 (0.00%)  0
Psychiatric disorders     
Depression  1  0/572 (0.00%)  0 1/572 (0.17%)  1
Renal and urinary disorders     
Renal failure acute  1  0/572 (0.00%)  0 1/572 (0.17%)  1
Urinary retention  1  1/572 (0.17%)  1 0/572 (0.00%)  0
Reproductive system and breast disorders     
Postmenopausal haemorrhage  1  0/572 (0.00%)  0 1/572 (0.17%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  0/572 (0.00%)  0 1/572 (0.17%)  1
Dyspnoea  1  1/572 (0.17%)  1 1/572 (0.17%)  1
Epistaxis  1  1/572 (0.17%)  1 0/572 (0.00%)  0
Sleep apnoea syndrome  1  0/572 (0.00%)  0 1/572 (0.17%)  1
Skin and subcutaneous tissue disorders     
Pruritus  1  1/572 (0.17%)  1 0/572 (0.00%)  0
Vascular disorders     
Accelerated hypertension  1  1/572 (0.17%)  1 1/572 (0.17%)  1
Diabetic macroangiopathy  1  1/572 (0.17%)  1 0/572 (0.00%)  0
Flushing  1  1/572 (0.17%)  1 0/572 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Extended-release Niacin/Laropiprant Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   101/572 (17.66%)      16/572 (2.80%)    
Skin and subcutaneous tissue disorders     
Pruritus  1  45/572 (7.87%)  52 3/572 (0.52%)  3
Vascular disorders     
Flushing  1  66/572 (11.54%)  100 13/572 (2.27%)  18
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
MK-0524A-133 was stopped prior to completion. Raw individual efficacy data were obtained but none of planned efficacy outcomes were summarized or analyzed. Only safety data were summarized.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication timelines.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01274559     History of Changes
Other Study ID Numbers: 0524A-133
CTRI/2012/08/002857 ( Registry Identifier: CTRI )
First Submitted: October 25, 2010
First Posted: January 11, 2011
Results First Submitted: January 30, 2014
Results First Posted: March 14, 2014
Last Update Posted: August 16, 2018