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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
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.
No text entered.

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 
Overall Participants Analyzed 
[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) ]

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  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):

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