Trial · NCT00961636

A Long-term Study of ERN/LRPT (Extended Release Niacin/Laropiprant [MK0524A]) in Patients With Dyslipidemia (0524A-102)

NCT00961636, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2012-02-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Long-term Study of ERN/LRPT (Extended Release Niacin/Laropiprant [MK0524A]) in Patients With Dyslipidemia (0524A-102). Trials, record NCT00961636. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00961636

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Long-term Study of ERN/LRPT (Extended Release Niacin/Laropiprant [MK0524A]) in Patients With Dyslipidemia (0524A-102)
NCT number: NCT00961636
Status: Completed
Phases: Phase 3
Enrollment: 1,152 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Dyslipidemia
Interventions: ER niacin (+) laropiprant (ERN/LRPT), ER niacin (+) laropiprant (ERN/LRPT), Extended-release niacin (ERN), Placebo to ERN/LRPT
First posted: 2009-08-19
Last updated: 2015-02-16
Results first posted: 2012-02-17

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period	Week 21 to Week 32	Flushing symptoms were recorded using participant's response to the Global Flushing Severity Score (GFSS), which assessed the overall severity of the flushing experience, using a scale of 0 (no symptom) to 10 (extreme). The number of days/week was derived as: 7\*(total number of days with GFSS ≥4 across Weeks 21-32 divided by the total number of days with nonmissing GFSS across the same period). The number of days/week with a GFSS ≥4 for each participant was listed in 1 of the following 6 categories: 0, \>0 to 0.5, \>0.5 to 1, \>1 to 2, \>2 to 3, and \>3 days per week.
Secondary	Number of Participants With Maximum GFSS ≥4 During the Post-withdrawal Period	Week 21 to Week 32	Flushing symptoms were recorded using participant's response to the Global Flushing Severity Score (GFSS), which assesses the overall severity of the flushing experience (including redness, warmth, tingling, or itching) using a scale with response categories of None, Mild, Moderate, Severe, and Extreme. The categories were supplemented with numbers 0 to 10 to allow for greater precision within each category (None=0, Mild=1-3, Moderate=4-6, Severe=7-9, Extreme=10). The daily response was recorded in the morning, and reflected the symptoms experienced during the previous 24 hours.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period	Week 21 to Week 32	Analysis performed using the Full Analysis Set (FAS) population which included all randomized participants that did not have a withdrawal visit and/or did not have at least 1 GFSS score during the post-withdrawal period (Weeks 21 to 32).	Participants	NUMBER
SECONDARY	Number of Participants With Maximum GFSS ≥4 During the Post-withdrawal Period	Week 21 to Week 32	Analysis performed using the Full Analysis Set (FAS) population which included all randomized participants that did not have a withdrawal visit and/or did not have at least 1 GFSS score during the post-withdrawal period (Weeks 21 to 32).	Participants	NUMBER

Source ClinicalTrials.gov

Results by group21

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period	ERN/LRPT	0 Days per week	291	Participants
Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period	ERN/LRPT Then ERN	0 Days per week	181	Participants
Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period	Placebo	0 Days per week	188	Participants
Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period	ERN/LRPT	>0 to ≤ 0.5 Days per week	43	Participants
Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period	ERN/LRPT Then ERN	>0 to ≤ 0.5 Days per week	74	Participants
Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period	Placebo	>0 to ≤ 0.5 Days per week	7	Participants
Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period	ERN/LRPT	>0.5 to ≤1 Days per week	3	Participants
Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period	ERN/LRPT Then ERN	>0.5 to ≤1 Days per week	32	Participants
Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period	Placebo	>0.5 to ≤1 Days per week	4	Participants
Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period	ERN/LRPT	>1.0 to ≤2 Days per week	8	Participants

1 to 10 of 21Source ClinicalTrials.gov

See all 21 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	ERN/LRPT	463
Overall Study	STARTED	ERN/LRPT Then ERN	456
Overall Study	STARTED	Placebo	233
Overall Study	COMPLETED	ERN/LRPT	356
Overall Study	COMPLETED	ERN/LRPT Then ERN	325
Overall Study	COMPLETED	Placebo	201
Overall Study	NOT COMPLETED	ERN/LRPT	107
Overall Study	NOT COMPLETED	ERN/LRPT Then ERN	131
Overall Study	NOT COMPLETED	Placebo	32

Source ClinicalTrials.gov

Adverse events192

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nasopharyngitis	Infections and infestations	ERN/LRPT	33	461	40
other	Nasopharyngitis	Infections and infestations	ERN/LRPT Then ERN	34	455	35
other	Nasopharyngitis	Infections and infestations	Placebo	11	232	12
other	Paraesthesia	Nervous system disorders	ERN/LRPT	23	461	53
other	Paraesthesia	Nervous system disorders	ERN/LRPT Then ERN	28	455	65
other	Paraesthesia	Nervous system disorders	Placebo	6	232	6
other	Pruritis	Skin and subcutaneous tissue disorders	ERN/LRPT	51	461	67
other	Pruritis	Skin and subcutaneous tissue disorders	ERN/LRPT Then ERN	66	455	116
other	Pruritis	Skin and subcutaneous tissue disorders	Placebo	17	232	18
other	Flushing	Vascular disorders	ERN/LRPT	52	461	77

1 to 10 of 192Source ClinicalTrials.gov

See all 192 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ERN/LRPT
Total, all-cause mortality	ERN/LRPT Then ERN
Total, all-cause mortality	Placebo
Total, other adverse events	ERN/LRPT	136	461
Total, other adverse events	ERN/LRPT Then ERN	162	455
Total, other adverse events	Placebo	37	232
Total, serious adverse events	ERN/LRPT	17	461
Total, serious adverse events	ERN/LRPT Then ERN	34	455
Total, serious adverse events	Placebo	13	232

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22683042	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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