Trial Outcomes & Findings for Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143) (NCT NCT01335997)
NCT ID: NCT01335997
Last Updated: 2019-02-06
Results Overview
Due to study termination caused by the decision to stop the development of the combination tablet, sufficient data were not available to perform the planned efficacy analysis, which is based on the cross-over data collected in period II and III.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1139 participants
Primary outcome timeframe
Baseline and Week 12 and Week 20
Results posted on
2019-02-06
Participant Flow
Sequence 1 (randomized) = 577; Sequence 2 (randomized) = 562
Participant milestones
| Measure |
ERN/LRPT/SIM → ERN/LRPT+SIM (Sequence 1)
Study drug was administered as extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period I and II for 12 weeks and extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) during Period III for 8 weeks.
|
ERN/LRPT+SIM → ERN/LRPT/SIM (Sequence 2)
Study drug was co-administered as extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) (ERN/LRPT + SIM) during Periods I and II for 12 weeks and extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period III for 8 weeks.
|
|---|---|---|
|
Period I and II
STARTED
|
577
|
562
|
|
Period I and II
COMPLETED
|
84
|
83
|
|
Period I and II
NOT COMPLETED
|
493
|
479
|
|
Period III
STARTED
|
84
|
83
|
|
Period III
COMPLETED
|
6
|
4
|
|
Period III
NOT COMPLETED
|
78
|
79
|
Reasons for withdrawal
| Measure |
ERN/LRPT/SIM → ERN/LRPT+SIM (Sequence 1)
Study drug was administered as extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period I and II for 12 weeks and extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) during Period III for 8 weeks.
|
ERN/LRPT+SIM → ERN/LRPT/SIM (Sequence 2)
Study drug was co-administered as extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) (ERN/LRPT + SIM) during Periods I and II for 12 weeks and extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period III for 8 weeks.
|
|---|---|---|
|
Period I and II
Adverse Event
|
63
|
43
|
|
Period I and II
Noncompliance with Study Drug
|
1
|
1
|
|
Period I and II
Lost to Follow-up
|
3
|
5
|
|
Period I and II
Withdrawal by Subject
|
9
|
4
|
|
Period I and II
Study Terminated by Sponsor
|
406
|
415
|
|
Period I and II
Protocol Violation
|
9
|
10
|
|
Period I and II
Physician Decision
|
2
|
1
|
|
Period III
Adverse Event
|
0
|
2
|
|
Period III
Study Terminated by Sponsor
|
77
|
76
|
|
Period III
Protocol Violation
|
0
|
1
|
|
Period III
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143)
Baseline characteristics by cohort
| Measure |
ERN/LRPT/SIM → ERN/LRPT+SIM (Sequence 1)
n=577 Participants
Study drug was administered as extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period I and II for 12 weeks and extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) during Period III for 8 weeks.
|
ERN/LRPT+SIM → ERN/LRPT/SIM (Sequence 2)
n=562 Participants
Study drug was co-administered as extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) (ERN/LRPT + SIM) during Periods I and II for 12 weeks and extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period III for 8 weeks.
|
Total
n=1139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.2 Years
STANDARD_DEVIATION 10.44 • n=5 Participants
|
56.4 Years
STANDARD_DEVIATION 10.44 • n=7 Participants
|
56.3 Years
STANDARD_DEVIATION 10.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
345 Participants
n=5 Participants
|
332 Participants
n=7 Participants
|
677 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
232 Participants
n=5 Participants
|
230 Participants
n=7 Participants
|
462 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12 and Week 20Population: Completers Population - participants that completed the study, have respective endpoint data available at baseline, end of period II and end of period III and were not off study drug more than 3 days prior to their period II and period III observations.
Due to study termination caused by the decision to stop the development of the combination tablet, sufficient data were not available to perform the planned efficacy analysis, which is based on the cross-over data collected in period II and III.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12 and Week 20Population: Completers Population - participants that completed the study, have respective endpoint data available at baseline, end of period II and end of period III and were not off study drug more than 3 days prior to their period II and period III observations.
Due to study termination caused by the decision to stop the development of the combination tablet, sufficient data were not available to perform the planned efficacy analysis, which is based on the cross-over data collected in period II and III.
Outcome measures
Outcome data not reported
Adverse Events
Seq 1 (Periods I+II): ERN/LRPT/SIMVA → ERN/LRPT+SIMVA
Serious events: 11 serious events
Other events: 103 other events
Deaths: 0 deaths
Seq 2 (Periods I+II): ERN/LRPT+SIM → ERN/LRPT/SIM
Serious events: 5 serious events
Other events: 95 other events
Deaths: 0 deaths
Seq 1 (Period III): ERN/LRPT/SIMVA → ERN/LRPT+SIMVA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Seq 2 (Period III): ERN/LRPT+SIM → ERN/LRPT/SIM
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Seq 1 (Periods I+II): ERN/LRPT/SIMVA → ERN/LRPT+SIMVA
n=567 participants at risk
ERN/LRPT/SIMVA 1 g/10 mg for 4 weeks (Period I) followed by ERN/LRPT/SIMVA 2 g/20 mg for 8 weeks (Period II)
|
Seq 2 (Periods I+II): ERN/LRPT+SIM → ERN/LRPT/SIM
n=554 participants at risk
ERN/LRPT 1 g + SIMVA 10 mg for 4 weeks (Period I) followed by ERN/LRPT 2 g + SIMVA 20 mg for 8 weeks (Period II)
|
Seq 1 (Period III): ERN/LRPT/SIMVA → ERN/LRPT+SIMVA
n=83 participants at risk
ERN/LRPT 2 g + SIMVA 20 mg for 8 weeks (Period III)
|
Seq 2 (Period III): ERN/LRPT+SIM → ERN/LRPT/SIM
n=82 participants at risk
ERN/LRPT/SIMVA 2 g/20 mg for 8 weeks (Period III)
|
|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.18%
1/567 • Number of events 1 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/554 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/83 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/82 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
|
Cardiac disorders
Arteriospasm coronary
|
0.00%
0/567 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.18%
1/554 • Number of events 1 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/83 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/82 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/567 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.18%
1/554 • Number of events 1 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/83 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/82 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.18%
1/567 • Number of events 1 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/554 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/83 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/82 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.18%
1/567 • Number of events 1 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/554 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/83 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/82 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
|
General disorders
Non-cardiac chest pain
|
0.18%
1/567 • Number of events 1 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/554 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/83 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/82 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
|
Infections and infestations
Pneumonia
|
0.18%
1/567 • Number of events 1 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/554 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/83 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/82 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.18%
1/567 • Number of events 1 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/554 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/83 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/82 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.18%
1/567 • Number of events 1 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/554 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/83 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/82 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.18%
1/567 • Number of events 1 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/554 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/83 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/82 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.18%
1/567 • Number of events 1 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/554 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/83 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/82 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma malignant
|
0.18%
1/567 • Number of events 1 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/554 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/83 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/82 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/567 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.18%
1/554 • Number of events 1 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/83 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/82 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
|
Nervous system disorders
Dizziness
|
0.18%
1/567 • Number of events 1 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/554 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/83 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/82 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
|
Psychiatric disorders
Anxiety
|
0.18%
1/567 • Number of events 1 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/554 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/83 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/82 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
|
Psychiatric disorders
Depression
|
0.18%
1/567 • Number of events 1 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/554 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/83 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/82 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.18%
1/567 • Number of events 1 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/554 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/83 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/82 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.18%
1/567 • Number of events 1 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/554 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/83 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/82 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
|
Vascular disorders
Flushing
|
0.18%
1/567 • Number of events 1 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.36%
2/554 • Number of events 2 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/83 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/82 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/567 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/554 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/83 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
1.2%
1/82 • Number of events 1 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
Other adverse events
| Measure |
Seq 1 (Periods I+II): ERN/LRPT/SIMVA → ERN/LRPT+SIMVA
n=567 participants at risk
ERN/LRPT/SIMVA 1 g/10 mg for 4 weeks (Period I) followed by ERN/LRPT/SIMVA 2 g/20 mg for 8 weeks (Period II)
|
Seq 2 (Periods I+II): ERN/LRPT+SIM → ERN/LRPT/SIM
n=554 participants at risk
ERN/LRPT 1 g + SIMVA 10 mg for 4 weeks (Period I) followed by ERN/LRPT 2 g + SIMVA 20 mg for 8 weeks (Period II)
|
Seq 1 (Period III): ERN/LRPT/SIMVA → ERN/LRPT+SIMVA
n=83 participants at risk
ERN/LRPT 2 g + SIMVA 20 mg for 8 weeks (Period III)
|
Seq 2 (Period III): ERN/LRPT+SIM → ERN/LRPT/SIM
n=82 participants at risk
ERN/LRPT/SIMVA 2 g/20 mg for 8 weeks (Period III)
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.9%
39/567 • Number of events 43 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
5.2%
29/554 • Number of events 33 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/83 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/82 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
|
Vascular disorders
Flushing
|
13.8%
78/567 • Number of events 90 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
13.0%
72/554 • Number of events 78 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/83 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
0.00%
0/82 • Up to 22 weeks, including 14 days after last dose of study drug (non-serious adverse events up to 20 weeks and serious adverse events up to 22 weeks)
The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one (1) dose of study treatment post-randomization. Participants were included in the treatment sequences corresponding to the study treatment they actually received.
|
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.
- Publication restrictions are in place
Restriction type: OTHER