Trial record 1 of 1 for: hps2 thrive

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

This study has been completed.

Sponsor:

Collaborator:

Merck Sharp & Dohme Corp.

Information provided by (Responsible Party):

Jane Armitage, University of Oxford

ClinicalTrials.gov Identifier:

NCT00461630

First received: April 17, 2007

Last updated: January 27, 2014

Last verified: January 2014

History of Changes

Results First Received: July 12, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Conditions:	Cardiovascular Disease Peripheral Arterial Disease Diabetes Mellitus Coronary Heart Disease
Interventions:	Drug: ER niacin/laropiprant Drug: simvastatin Drug: ezetimibe/simvastatin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
245 sites January 2007 to July 2010

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to randomization, each participant received simvastatin 40mg daily; if this dose was not as effective as their prior statin treatment or their total cholesterol was ≥135 mg/dl after 4 weeks on simvastatin alone, ezetimibe 10mg daily was added. Participants then received ERN/LRPT 1g/20mg daily for 4 weeks followed by 2g/40mg daily for 4 weeks.

Reporting Groups

	Description
ER Niacin/Laropiprant	I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
Placebo	Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily

Participant Flow: Overall Study

	ER Niacin/Laropiprant	Placebo
STARTED	12838	12835
COMPLETED	11932	12008
NOT COMPLETED	906	827
Death	798	732
Lost to Follow-up	108	95

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
ER Niacin/Laropiprant	I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
Placebo	Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
Total	Total of all reporting groups

Baseline Measures

	ER Niacin/Laropiprant	Placebo	Total
Number of Participants [units: participants]	12838	12835	25673
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	6470	6462	12932
>=65 years	6368	6373	12741
Age [units: years] Mean (Standard Deviation)
Age	64.9 (7.5)	64.9 (7.5)	64.9 (7.5)
Gender [units: participants]
Female	2224	2220	4444
Male	10614	10615	21229
Region of Enrollment [units: participants]
China	5464	5468	10932
Europe	7374	7367	14741

Outcome Measures

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1. Primary:

Major Vascular Event [ Time Frame: During scheduled treatment period (median duration 3.9 years) ]

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2. Secondary:

Major Coronary Events [ Time Frame: During scheduled treatment period (median duration 3.9 years) ]

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3. Secondary:

Stroke [ Time Frame: During scheduled treatment period (median duration 3.9 years) ]

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4. Secondary:

Coronary or Non-coronary Revascularisation [ Time Frame: During scheduled treatment period (median duration 3.9 years) ]

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5. Secondary:

Mortality [ Time Frame: During scheduled treatment period (median duration 3.9 years) ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Participants may have SAEs reported in >1 category hence total participants affected across reported categories is less than total given.

More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:

Name/Title: Professor Jane Armitage
Organization: Clinical Trial Service Unit, University of Oxford
phone: +44 (0)1865 743743
e-mail: thrive@ctsu.ox.ac.uk

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

HPS2-THRIVE Collaborative Group, Landray MJ, Haynes R, Hopewell JC, Parish S, Aung T, Tomson J, Wallendszus K, Craig M, Jiang L, Collins R, Armitage J. Effects of extended-release niacin with laropiprant in high-risk patients. N Engl J Med. 2014 Jul 17;371(3):203-12. doi: 10.1056/NEJMoa1300955.

Responsible Party:	Jane Armitage, University of Oxford
ClinicalTrials.gov Identifier:	NCT00461630 History of Changes
Other Study ID Numbers:	CTSUTHRIVE1 ISRCTN29503772 2006-001885-17 ( EudraCT Number )
Study First Received:	April 17, 2007
Results First Received:	July 12, 2013
Last Updated:	January 27, 2014
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency China: Food and Drug Administration Norway: Norwegian Medicines Agency Sweden: Medical Products Agency Finland: Finnish Medicines Agency Denmark: Danish Medicines Agency

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