Trial Outcomes & Findings for Niacin/Laropiprant Tablet for South and Southeast Asians With Low High-Density Lipoprotein Cholesterol (LDL-C) at Risk for Cardiovascular Disease (MK-0524A-108) (NCT NCT01414166)
NCT ID: NCT01414166
Last Updated: 2015-05-13
Results Overview
The percentage change from baseline in the participants' LDL-C was to be evaluated and averaged across treatment Week 12 and Week 16.
TERMINATED
PHASE3
244 participants
Baseline and Weeks 12 to 16
2015-05-13
Participant Flow
This study took place at 37 centers in 2 countries (29 sites in India and 8 sites in Philippines).
Participant milestones
| Measure |
ERN/LPRT
Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
|
Placebo
Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
|
|---|---|---|
|
Overall Study
STARTED
|
122
|
122
|
|
Overall Study
Treated
|
120
|
121
|
|
Overall Study
COMPLETED
|
31
|
39
|
|
Overall Study
NOT COMPLETED
|
91
|
83
|
Reasons for withdrawal
| Measure |
ERN/LPRT
Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
|
Placebo
Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
|
Overall Study
Non-compliance with study drug
|
2
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Study terminated by Sponsor
|
68
|
75
|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
Baseline Characteristics
Niacin/Laropiprant Tablet for South and Southeast Asians With Low High-Density Lipoprotein Cholesterol (LDL-C) at Risk for Cardiovascular Disease (MK-0524A-108)
Baseline characteristics by cohort
| Measure |
ERN/LPRT
n=122 Participants
Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
|
Placebo
n=122 Participants
Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
|
Total
n=244 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.8 Years
STANDARD_DEVIATION 9.30 • n=5 Participants
|
45.3 Years
STANDARD_DEVIATION 10.18 • n=7 Participants
|
45.5 Years
STANDARD_DEVIATION 9.73 • n=5 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Weeks 12 to 16Population: Due to early study termination, this efficacy endpoint was not analyzed.
The percentage change from baseline in the participants' LDL-C was to be evaluated and averaged across treatment Week 12 and Week 16.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Due to early study termination, this efficacy endpoint was not analyzed
The percentage from baseline in the participants' ration of LDL-C to HDL-C was to be evaluated at study Week 16.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Due to early study termination, this efficacy endpoint was not analyzed.
The percentage change from baseline in the participants' HDL-C was to be evaluated at study Week 16.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Due to early study termination, this efficacy endpoint was not analyzed.
The percentage change from baseline in participants' TG level was to be evaluated at study Week 16.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Due to early study termination, this efficacy endpoint was not analyzed.
The percentage change from baseline in participants' non-HDL-C was to be calculated at study Week 16.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Due to early study termination, this efficacy endpoint was not analyzed.
The percentage change from baseline in the ratio of TC to HDL-C was to be evaluated at study Week 16.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Due to early study termination, this efficacy endpoint was not analyzed.
The pecentage change from baseline in participants LP(a) was to be evaluated at study Week 16.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Due to early study termination, this efficacy endpoint was not analyzed.
The percentage change from baseline in participants' Apo B was to be evaluated at study Week 16.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Due to early study termination, this efficacy endpoint was not analyzed.
The percentage change from baseline in participants' Apo A-I was to be evaluated at study Week 16.
Outcome measures
Outcome data not reported
Adverse Events
ERN/LPRT
Placebo
Serious adverse events
| Measure |
ERN/LPRT
n=120 participants at risk
Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
|
Placebo
n=121 participants at risk
Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
|
|---|---|---|
|
Infections and infestations
Urinary Tract Infection
|
0.83%
1/120 • Number of events 1 • Up to Week 20 for Serious Adverse Events; Up to Week 18 for Non-Serious Adverse Events.
The safety population consisted of all participants that received at least one dose of study drug.
|
0.00%
0/121 • Up to Week 20 for Serious Adverse Events; Up to Week 18 for Non-Serious Adverse Events.
The safety population consisted of all participants that received at least one dose of study drug.
|
Other adverse events
| Measure |
ERN/LPRT
n=120 participants at risk
Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
|
Placebo
n=121 participants at risk
Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
|
|---|---|---|
|
General disorders
Pyrexia
|
8.3%
10/120 • Number of events 10 • Up to Week 20 for Serious Adverse Events; Up to Week 18 for Non-Serious Adverse Events.
The safety population consisted of all participants that received at least one dose of study drug.
|
2.5%
3/121 • Number of events 3 • Up to Week 20 for Serious Adverse Events; Up to Week 18 for Non-Serious Adverse Events.
The safety population consisted of all participants that received at least one dose of study drug.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.2%
5/120 • Number of events 5 • Up to Week 20 for Serious Adverse Events; Up to Week 18 for Non-Serious Adverse Events.
The safety population consisted of all participants that received at least one dose of study drug.
|
5.8%
7/121 • Number of events 7 • Up to Week 20 for Serious Adverse Events; Up to Week 18 for Non-Serious Adverse Events.
The safety population consisted of all participants that received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Impaired Fasting Glucose
|
5.8%
7/120 • Number of events 8 • Up to Week 20 for Serious Adverse Events; Up to Week 18 for Non-Serious Adverse Events.
The safety population consisted of all participants that received at least one dose of study drug.
|
0.83%
1/121 • Number of events 1 • Up to Week 20 for Serious Adverse Events; Up to Week 18 for Non-Serious Adverse Events.
The safety population consisted of all participants that received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
15/120 • Number of events 25 • Up to Week 20 for Serious Adverse Events; Up to Week 18 for Non-Serious Adverse Events.
The safety population consisted of all participants that received at least one dose of study drug.
|
3.3%
4/121 • Number of events 4 • Up to Week 20 for Serious Adverse Events; Up to Week 18 for Non-Serious Adverse Events.
The safety population consisted of all participants that received at least one dose of study drug.
|
|
Vascular disorders
Flushing
|
10.0%
12/120 • Number of events 18 • Up to Week 20 for Serious Adverse Events; Up to Week 18 for Non-Serious Adverse Events.
The safety population consisted of all participants that received at least one dose of study drug.
|
2.5%
3/121 • Number of events 11 • Up to Week 20 for Serious Adverse Events; Up to Week 18 for Non-Serious Adverse Events.
The safety population consisted of all participants that received at least one dose of study drug.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
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.
- Publication restrictions are in place
Restriction type: OTHER