Trial Outcomes & Findings for 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) (NCT NCT01274559)
NCT ID: NCT01274559
Last Updated: 2024-05-22
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1173 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2024-05-22
Participant Flow
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.
Participant milestones
| Measure |
Extended-release Niacin/Laropiprant
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.
|
Placebo
Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
|
|---|---|---|
|
Overall Study
STARTED
|
587
|
586
|
|
Overall Study
Treated
|
572
|
572
|
|
Overall Study
COMPLETED
|
390
|
441
|
|
Overall Study
NOT COMPLETED
|
197
|
145
|
Reasons for withdrawal
| Measure |
Extended-release Niacin/Laropiprant
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.
|
Placebo
Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
|
|---|---|---|
|
Overall Study
Adverse Event
|
57
|
13
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Non-compliance with Study Drug
|
2
|
4
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Protocol Violation
|
28
|
23
|
|
Overall Study
Study Terminated by Sponsor
|
79
|
87
|
|
Overall Study
Withdrawal by Subject
|
25
|
13
|
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
Extended-release Niacin/Laropiprant
n=587 Participants
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.
|
Placebo
n=586 Participants
Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
|
Total
n=1173 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
21 to 30 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Customized
31 to 40 years
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Customized
41 to 50 years
|
63 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Age, Customized
51 to 60 years
|
182 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
350 Participants
n=5 Participants
|
|
Age, Customized
61 to 70 years
|
209 Participants
n=5 Participants
|
232 Participants
n=7 Participants
|
441 Participants
n=5 Participants
|
|
Age, Customized
71 to 80 years
|
108 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
|
Age, Customized
>80 years
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
239 Participants
n=5 Participants
|
243 Participants
n=7 Participants
|
482 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
348 Participants
n=5 Participants
|
343 Participants
n=7 Participants
|
691 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.
assessed as per National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) and European Society of Cardiology (ESC) treatment guidelines
Outcome measures
Outcome data not reported
Adverse Events
Extended-release Niacin/Laropiprant
Serious events: 23 serious events
Other events: 101 other events
Deaths: 0 deaths
Placebo
Serious events: 16 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Extended-release Niacin/Laropiprant
n=572 participants at risk
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.
|
Placebo
n=572 participants at risk
Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
|
|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Cardiac disorders
Atrial fibrillation
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Cardiac disorders
Bradycardia
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.35%
2/572 • Number of events 2 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Cardiac disorders
Coronary artery disease
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Ear and labyrinth disorders
Vertigo
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
General disorders
Non-cardiac chest pain
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.35%
2/572 • Number of events 2 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
General disorders
Sudden cardiac death
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Infections and infestations
Epiglottitis
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Infections and infestations
Gastroenteritis
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Infections and infestations
Puncture site infection
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.35%
2/572 • Number of events 2 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.35%
2/572 • Number of events 2 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Nervous system disorders
Syncope
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Psychiatric disorders
Depression
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Renal and urinary disorders
Urinary retention
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Vascular disorders
Accelerated hypertension
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Vascular disorders
Diabetic macroangiopathy
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Vascular disorders
Flushing
|
0.17%
1/572 • Number of events 1 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.00%
0/572 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
Other adverse events
| Measure |
Extended-release Niacin/Laropiprant
n=572 participants at risk
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.
|
Placebo
n=572 participants at risk
Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.9%
45/572 • Number of events 52 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
0.52%
3/572 • Number of events 3 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
|
Vascular disorders
Flushing
|
11.5%
66/572 • Number of events 100 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
2.3%
13/572 • Number of events 18 • up to 12 weeks
The All Patients as Treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment post randomization.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER