Trial · NCT00461630

Treatment of HDL to Reduce the Incidence of Vascular Events HPS2-THRIVE

NCT00461630, Phase 3, Completed, University of Oxford; results first posted 2014-01-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Treatment of HDL to Reduce the Incidence of Vascular Events HPS2-THRIVE. Trials, record NCT00461630. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00461630

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Trial

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

Title: Treatment of HDL to Reduce the Incidence of Vascular Events HPS2-THRIVE
NCT number: NCT00461630
Status: Completed
Phases: Phase 3
Enrollment: 25,673 participants, actual
Lead sponsor: University of Oxford
Conditions: Cardiovascular Disease, Peripheral Arterial Disease, Diabetes Mellitus, Coronary Heart Disease
Interventions: ER niacin/laropiprant, simvastatin, ezetimibe/simvastatin
First posted: 2007-04-18
Last updated: 2014-02-28
Other registries' IDs: eudract:2006-001885-17, isrctn:ISRCTN29503772
Results first posted: 2014-01-28
Limitations and caveats: Participants may have SAEs reported in \>1 category hence total participants affected across reported categories is less than total given.

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Major Vascular Event	During scheduled treatment period (median duration 3.9 years)	Non-fatal myocardial infarction or coronary death, non-fatal or fatal stroke, or revascularisation
Secondary	Major Coronary Events	During scheduled treatment period (median duration 3.9 years)	Non-fatal myocardial infarction (MI) or coronary death
Secondary	Stroke	During scheduled treatment period (median duration 3.9 years)	Fatal or non-fatal
Secondary	Coronary or Non-coronary Revascularisation	During scheduled treatment period (median duration 3.9 years)
Secondary	Mortality	During scheduled treatment period (median duration 3.9 years)	All-cause mortality

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Major Vascular Event	During scheduled treatment period (median duration 3.9 years)	participants	NUMBER
SECONDARY	Major Coronary Events	During scheduled treatment period (median duration 3.9 years)	participants	NUMBER
SECONDARY	Stroke	During scheduled treatment period (median duration 3.9 years)	participants	NUMBER
SECONDARY	Coronary or Non-coronary Revascularisation	During scheduled treatment period (median duration 3.9 years)	participants	NUMBER
SECONDARY	Mortality	During scheduled treatment period (median duration 3.9 years)	participants	NUMBER

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Value	Units
Major Vascular Event	ER Niacin/Laropiprant	1696	participants
Major Vascular Event	Placebo	1758	participants
Major Coronary Events	ER Niacin/Laropiprant	668	participants
Major Coronary Events	Placebo	694	participants
Stroke	ER Niacin/Laropiprant	498	participants
Stroke	Placebo	499	participants
Coronary or Non-coronary Revascularisation	ER Niacin/Laropiprant	807	participants
Coronary or Non-coronary Revascularisation	Placebo	897	participants
Mortality	ER Niacin/Laropiprant	798	participants
Mortality	Placebo	732	participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	ER Niacin/Laropiprant	12,838
Overall Study	STARTED	Placebo	12,835
Overall Study	COMPLETED	ER Niacin/Laropiprant	11,932
Overall Study	COMPLETED	Placebo	12,008
Overall Study	NOT COMPLETED	ER Niacin/Laropiprant	906
Overall Study	NOT COMPLETED	Placebo	827

Source ClinicalTrials.gov

Adverse events78

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
other	Cardiac disorders	Cardiac disorders	ER Niacin/Laropiprant	35	12,838
other	Cardiac disorders	Cardiac disorders	Placebo	13	12,835
other	Ear and labyrinth disorders	Ear and labyrinth disorders	ER Niacin/Laropiprant	3	12,838
other	Ear and labyrinth disorders	Ear and labyrinth disorders	Placebo	1	12,835
other	Eye disorders	Eye disorders	ER Niacin/Laropiprant	48	12,838
other	Eye disorders	Eye disorders	Placebo	27	12,835
other	Gastrointestinal disorders	Gastrointestinal disorders	ER Niacin/Laropiprant	1,168	12,838
other	Gastrointestinal disorders	Gastrointestinal disorders	Placebo	690	12,835
other	General disorders	General disorders	ER Niacin/Laropiprant	176	12,838
other	General disorders	General disorders	Placebo	138	12,835

1 to 10 of 78Source ClinicalTrials.gov

See all 78 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ER Niacin/Laropiprant
Total, all-cause mortality	Placebo
Total, other adverse events	ER Niacin/Laropiprant	4,248	12,838
Total, other adverse events	Placebo	2,238	12,835
Total, serious adverse events	ER Niacin/Laropiprant	7,137	12,838
Total, serious adverse events	Placebo	6,762	12,835

Source ClinicalTrials.gov

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25014686	DERIVED	PubMed
27407053	DERIVED	PubMed
29449329	DERIVED	PubMed
30821829	DERIVED	PubMed
31447131	DERIVED	PubMed
31805983	DERIVED	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 comparisons6

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

Comparison	Source
ER Niacin/Laropiprant vs Placebo: Major Vascular Event	Trial comparisons
ER Niacin/Laropiprant vs Placebo: Mortality	Trial comparisons
ER Niacin/Laropiprant vs Placebo: Major Coronary Events	Trial comparisons
ER Niacin/Laropiprant vs Placebo: Stroke	Trial comparisons
ER Niacin/Laropiprant vs Placebo: Coronary or Non-coronary Revascularisation	Trial comparisons
ER Niacin/Laropiprant vs Placebo: serious adverse events	Trial comparisons

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.

GET https://conductscience.org/api/trials/v1/NCT00461630

GET https://conductscience.org/api/trials/v1/NCT00461630/events?page=2

API reference For AI assistants