Trial Outcomes & Findings for A Study of Extended-release (ER) Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0524A-158) (NCT NCT01583647)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

10 participants

Primary outcome timeframe

Predose Day 1 up to 24 hours postdose

Results posted on

2015-11-03

Participant Flow

MK-0524A-158 was terminated after the Phase 3 study HPS2-THRIVE (MK-0524A-042;NCT00461630) didn't meet its primary endpoint of reduction of major vascular events; there was also a significant increase in some types of non-fatal serious adverse events. MK-0524A-158 was terminated after 10 participants completed Panel A. Panel B was not conducted.

Participant milestones

Participant milestones
Measure	MK-0524A 1 g/20 mg (Panel A) Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg	MK-0524A 2 g/40 mg (Panel B) Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
Overall Study STARTED	10	0
Overall Study COMPLETED	10	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Extended-release (ER) Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0524A-158)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MK-0524A 1 g/20 mg (Panel A) n=10 Participants Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
Age, Continuous	15.4 Years STANDARD_DEVIATION 0.8 • n=93 Participants
Sex: Female, Male Female	5 Participants n=93 Participants
Sex: Female, Male Male	5 Participants n=93 Participants

PRIMARY outcome

Timeframe: Predose Day 1 up to 24 hours postdose

Population: The study was terminated during Panel A and the decision was made to not analyze the blood and urine pharmacokinetic samples collected during Panel A; Panel B was not conducted.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Predose on Day 1 up to 48 hours postdose

Population: The study was terminated during Panel A and the decision was made to not analyze the blood and urine pharmacokinetic samples collected during Panel A; Panel B was not conducted.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Predose on Day 1 up to 72 hours postdose

Population: The study was terminated during Panel A and the decision was made to not analyze the blood and urine pharmacokinetic samples collected during Panel A; Panel B was not conducted.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Predose on Day 1 up to 48 hours postdose

Population: The study was terminated during Panel A and the decision was made to not analyze the blood and urine pharmacokinetic samples collected during Panel A; Panel B was not conducted.

Outcome measures

Outcome data not reported

Adverse Events

MK-0524A 1 g/20 mg (Panel A)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

MK-0524A 2 g/40 mg (Panel B)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MK-0524A 1 g/20 mg (Panel A) n=10 participants at risk Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg	MK-0524A 2 g/40 mg (Panel B) Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
Gastrointestinal disorders Abdominal pain lower	10.0% 1/10 • Number of events 1 • up to 14 days for each panel MK-0524A-158 was terminated after the Phase 3 study HPS2-THRIVE (MK-0524A-042) didn't meet its primary endpoint of reduction of major vascular events; there was also a significant increase in some types of non-fatal serious adverse events in HPS2-THRIVE. MK-0524A-158 was terminated after 10 participants completed Panel A. Panel B was not conducted.	— 0/0 • up to 14 days for each panel MK-0524A-158 was terminated after the Phase 3 study HPS2-THRIVE (MK-0524A-042) didn't meet its primary endpoint of reduction of major vascular events; there was also a significant increase in some types of non-fatal serious adverse events in HPS2-THRIVE. MK-0524A-158 was terminated after 10 participants completed Panel A. Panel B was not conducted.
Injury, poisoning and procedural complications Bruising of arm	10.0% 1/10 • Number of events 1 • up to 14 days for each panel MK-0524A-158 was terminated after the Phase 3 study HPS2-THRIVE (MK-0524A-042) didn't meet its primary endpoint of reduction of major vascular events; there was also a significant increase in some types of non-fatal serious adverse events in HPS2-THRIVE. MK-0524A-158 was terminated after 10 participants completed Panel A. Panel B was not conducted.	— 0/0 • up to 14 days for each panel MK-0524A-158 was terminated after the Phase 3 study HPS2-THRIVE (MK-0524A-042) didn't meet its primary endpoint of reduction of major vascular events; there was also a significant increase in some types of non-fatal serious adverse events in HPS2-THRIVE. MK-0524A-158 was terminated after 10 participants completed Panel A. Panel B was not conducted.
Injury, poisoning and procedural complications Sprain	10.0% 1/10 • Number of events 1 • up to 14 days for each panel MK-0524A-158 was terminated after the Phase 3 study HPS2-THRIVE (MK-0524A-042) didn't meet its primary endpoint of reduction of major vascular events; there was also a significant increase in some types of non-fatal serious adverse events in HPS2-THRIVE. MK-0524A-158 was terminated after 10 participants completed Panel A. Panel B was not conducted.	— 0/0 • up to 14 days for each panel MK-0524A-158 was terminated after the Phase 3 study HPS2-THRIVE (MK-0524A-042) didn't meet its primary endpoint of reduction of major vascular events; there was also a significant increase in some types of non-fatal serious adverse events in HPS2-THRIVE. MK-0524A-158 was terminated after 10 participants completed Panel A. Panel B was not conducted.
Musculoskeletal and connective tissue disorders Low back pain	10.0% 1/10 • Number of events 1 • up to 14 days for each panel MK-0524A-158 was terminated after the Phase 3 study HPS2-THRIVE (MK-0524A-042) didn't meet its primary endpoint of reduction of major vascular events; there was also a significant increase in some types of non-fatal serious adverse events in HPS2-THRIVE. MK-0524A-158 was terminated after 10 participants completed Panel A. Panel B was not conducted.	— 0/0 • up to 14 days for each panel MK-0524A-158 was terminated after the Phase 3 study HPS2-THRIVE (MK-0524A-042) didn't meet its primary endpoint of reduction of major vascular events; there was also a significant increase in some types of non-fatal serious adverse events in HPS2-THRIVE. MK-0524A-158 was terminated after 10 participants completed Panel A. Panel B was not conducted.
Nervous system disorders Headache	20.0% 2/10 • Number of events 2 • up to 14 days for each panel MK-0524A-158 was terminated after the Phase 3 study HPS2-THRIVE (MK-0524A-042) didn't meet its primary endpoint of reduction of major vascular events; there was also a significant increase in some types of non-fatal serious adverse events in HPS2-THRIVE. MK-0524A-158 was terminated after 10 participants completed Panel A. Panel B was not conducted.	— 0/0 • up to 14 days for each panel MK-0524A-158 was terminated after the Phase 3 study HPS2-THRIVE (MK-0524A-042) didn't meet its primary endpoint of reduction of major vascular events; there was also a significant increase in some types of non-fatal serious adverse events in HPS2-THRIVE. MK-0524A-158 was terminated after 10 participants completed Panel A. Panel B was not conducted.
Renal and urinary disorders Diuresis	10.0% 1/10 • Number of events 1 • up to 14 days for each panel MK-0524A-158 was terminated after the Phase 3 study HPS2-THRIVE (MK-0524A-042) didn't meet its primary endpoint of reduction of major vascular events; there was also a significant increase in some types of non-fatal serious adverse events in HPS2-THRIVE. MK-0524A-158 was terminated after 10 participants completed Panel A. Panel B was not conducted.	— 0/0 • up to 14 days for each panel MK-0524A-158 was terminated after the Phase 3 study HPS2-THRIVE (MK-0524A-042) didn't meet its primary endpoint of reduction of major vascular events; there was also a significant increase in some types of non-fatal serious adverse events in HPS2-THRIVE. MK-0524A-158 was terminated after 10 participants completed Panel A. Panel B was not conducted.
Skin and subcutaneous tissue disorders Pruritus	10.0% 1/10 • Number of events 1 • up to 14 days for each panel MK-0524A-158 was terminated after the Phase 3 study HPS2-THRIVE (MK-0524A-042) didn't meet its primary endpoint of reduction of major vascular events; there was also a significant increase in some types of non-fatal serious adverse events in HPS2-THRIVE. MK-0524A-158 was terminated after 10 participants completed Panel A. Panel B was not conducted.	— 0/0 • up to 14 days for each panel MK-0524A-158 was terminated after the Phase 3 study HPS2-THRIVE (MK-0524A-042) didn't meet its primary endpoint of reduction of major vascular events; there was also a significant increase in some types of non-fatal serious adverse events in HPS2-THRIVE. MK-0524A-158 was terminated after 10 participants completed Panel A. Panel B was not conducted.
Vascular disorders Facial flushing	10.0% 1/10 • Number of events 1 • up to 14 days for each panel MK-0524A-158 was terminated after the Phase 3 study HPS2-THRIVE (MK-0524A-042) didn't meet its primary endpoint of reduction of major vascular events; there was also a significant increase in some types of non-fatal serious adverse events in HPS2-THRIVE. MK-0524A-158 was terminated after 10 participants completed Panel A. Panel B was not conducted.	— 0/0 • up to 14 days for each panel MK-0524A-158 was terminated after the Phase 3 study HPS2-THRIVE (MK-0524A-042) didn't meet its primary endpoint of reduction of major vascular events; there was also a significant increase in some types of non-fatal serious adverse events in HPS2-THRIVE. MK-0524A-158 was terminated after 10 participants completed Panel A. Panel B was not conducted.
Vascular disorders Flushing	10.0% 1/10 • Number of events 1 • up to 14 days for each panel MK-0524A-158 was terminated after the Phase 3 study HPS2-THRIVE (MK-0524A-042) didn't meet its primary endpoint of reduction of major vascular events; there was also a significant increase in some types of non-fatal serious adverse events in HPS2-THRIVE. MK-0524A-158 was terminated after 10 participants completed Panel A. Panel B was not conducted.	— 0/0 • up to 14 days for each panel MK-0524A-158 was terminated after the Phase 3 study HPS2-THRIVE (MK-0524A-042) didn't meet its primary endpoint of reduction of major vascular events; there was also a significant increase in some types of non-fatal serious adverse events in HPS2-THRIVE. MK-0524A-158 was terminated after 10 participants completed Panel A. Panel B was not conducted.

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