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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00658515
Registration number
NCT00658515
Ethics application status
Date submitted
28/03/2008
Date registered
15/04/2008
Date last updated
3/01/2020
Titles & IDs
Public title
A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome
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Scientific title
A Randomized, Double-blind, Placebo-controlled Study Assessing the Effect of RO4607381 on Cardiovascular Mortality and Morbidity in Clinically Stable Patients With a Recent Acute Coronary Syndrome
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Secondary ID [1]
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0
2007-005103-18
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Secondary ID [2]
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NC20971
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Coronary Heart Disease
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Condition category
Condition code
Cardiovascular
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0
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0
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Coronary heart disease
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Cardiovascular
0
0
0
0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Dalcetrapib (RO4607381)
Treatment: Drugs - Evidence-based medical care for Acute Coronary Syndrome
Treatment: Drugs - Placebo
Experimental: Dalcetrapib (RO4607381) -
Placebo comparator: Placebo -
Treatment: Drugs: Dalcetrapib (RO4607381)
600mg po daily
Treatment: Drugs: Evidence-based medical care for Acute Coronary Syndrome
As prescribed
Treatment: Drugs: Placebo
po daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of Cardiovascular Mortality and Morbidity
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Assessment method [1]
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Number of cardiovascular events per patient per year
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Timepoint [1]
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From date of randomization to first event up to 48 months
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Secondary outcome [1]
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Composite Endpoint:All Cause Mortality
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Assessment method [1]
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Timepoint [1]
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Throughout Study, up to 53 Months
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Secondary outcome [2]
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Change From Baseline for HDL Cholesterol
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Assessment method [2]
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Timepoint [2]
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At 53 Months
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Secondary outcome [3]
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Adverse Events, Lab Parameters, Vital Signs, ECG
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Assessment method [3]
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Timepoint [3]
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Throughout Study, up to 53 Months
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Eligibility
Key inclusion criteria
* adult patients, >=45 years of age;
* recently hospitalized for ACS;
* clinically stable;
* receiving evidence-based medical and dietary management of dyslipidemia.
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Minimum age
45
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* uncontrolled diabetes;
* clinically unstable;
* severe anemia;
* uncontrolled hypertension;
* concomitant treatment with any other drug raising HDL-C (eg niacin, fibrates).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2012
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Sample size
Target
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Accrual to date
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Final
15871
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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- Garran
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2605 - Garran
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2450 - Coffs Harbour
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2137 - Concord
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3076 - Epping
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2747 - Kingswood
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2500 - Wollongong
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4870 - Cairns
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4032 - Chermside
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4064 - Milton
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4102 - Woolloongabba
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5042 - Bedford Park
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3128 - Box Hill
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3220 - Geelong
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3850 - Sale
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6027 - Joondalup
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6009 - Nedlands
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Czechia
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State/province [129]
0
0
Brno
Query!
Country [130]
0
0
Czechia
Query!
State/province [130]
0
0
Ceské Budejovice
Query!
Country [131]
0
0
Czechia
Query!
State/province [131]
0
0
Chrudim
Query!
Country [132]
0
0
Czechia
Query!
State/province [132]
0
0
Hradec Kralove
Query!
Country [133]
0
0
Czechia
Query!
State/province [133]
0
0
Jihlava
Query!
Country [134]
0
0
Czechia
Query!
State/province [134]
0
0
Jindrichuv Hradec
Query!
Country [135]
0
0
Czechia
Query!
State/province [135]
0
0
Karlovy Vary
Query!
Country [136]
0
0
Czechia
Query!
State/province [136]
0
0
Kromeriz
Query!
Country [137]
0
0
Czechia
Query!
State/province [137]
0
0
Nachod
Query!
Country [138]
0
0
Czechia
Query!
State/province [138]
0
0
Ostrava - Fifejdy
Query!
Country [139]
0
0
Czechia
Query!
State/province [139]
0
0
Pardubice
Query!
Country [140]
0
0
Czechia
Query!
State/province [140]
0
0
Prague 5
Query!
Country [141]
0
0
Czechia
Query!
State/province [141]
0
0
Prague
Query!
Country [142]
0
0
Czechia
Query!
State/province [142]
0
0
Praha
Query!
Country [143]
0
0
Czechia
Query!
State/province [143]
0
0
Semily
Query!
Country [144]
0
0
Czechia
Query!
State/province [144]
0
0
Slany
Query!
Country [145]
0
0
Czechia
Query!
State/province [145]
0
0
Tabor
Query!
Country [146]
0
0
Czechia
Query!
State/province [146]
0
0
Teplice
Query!
Country [147]
0
0
Czechia
Query!
State/province [147]
0
0
Trutnov
Query!
Country [148]
0
0
Czechia
Query!
State/province [148]
0
0
Zlin
Query!
Country [149]
0
0
Czechia
Query!
State/province [149]
0
0
Znojmo
Query!
Country [150]
0
0
Denmark
Query!
State/province [150]
0
0
Frederiksberg
Query!
Country [151]
0
0
Denmark
Query!
State/province [151]
0
0
Hellerup
Query!
Country [152]
0
0
Denmark
Query!
State/province [152]
0
0
Herlev
Query!
Country [153]
0
0
Denmark
Query!
State/province [153]
0
0
Herning
Query!
Country [154]
0
0
Denmark
Query!
State/province [154]
0
0
Hillerod
Query!
Country [155]
0
0
Denmark
Query!
State/province [155]
0
0
Kolding
Query!
Country [156]
0
0
Denmark
Query!
State/province [156]
0
0
København S
Query!
Country [157]
0
0
Denmark
Query!
State/province [157]
0
0
Køge
Query!
Country [158]
0
0
Denmark
Query!
State/province [158]
0
0
Roskilde
Query!
Country [159]
0
0
Denmark
Query!
State/province [159]
0
0
Svendborg
Query!
Country [160]
0
0
Finland
Query!
State/province [160]
0
0
Jyväskylä
Query!
Country [161]
0
0
Finland
Query!
State/province [161]
0
0
Kotka
Query!
Country [162]
0
0
Finland
Query!
State/province [162]
0
0
Kuopio
Query!
Country [163]
0
0
France
Query!
State/province [163]
0
0
Angers
Query!
Country [164]
0
0
France
Query!
State/province [164]
0
0
Bron
Query!
Country [165]
0
0
France
Query!
State/province [165]
0
0
Colmar
Query!
Country [166]
0
0
France
Query!
State/province [166]
0
0
Dijon
Query!
Country [167]
0
0
France
Query!
State/province [167]
0
0
Lille
Query!
Country [168]
0
0
France
Query!
State/province [168]
0
0
Marseille
Query!
Country [169]
0
0
France
Query!
State/province [169]
0
0
Montfermeil
Query!
Country [170]
0
0
France
Query!
State/province [170]
0
0
Paris
Query!
Country [171]
0
0
France
Query!
State/province [171]
0
0
Pessac
Query!
Country [172]
0
0
France
Query!
State/province [172]
0
0
Poitiers
Query!
Country [173]
0
0
France
Query!
State/province [173]
0
0
Roubaix
Query!
Country [174]
0
0
France
Query!
State/province [174]
0
0
St Herblain
Query!
Country [175]
0
0
France
Query!
State/province [175]
0
0
Strasbourg
Query!
Country [176]
0
0
France
Query!
State/province [176]
0
0
Tourcoing
Query!
Country [177]
0
0
France
Query!
State/province [177]
0
0
Valenciennes
Query!
Country [178]
0
0
France
Query!
State/province [178]
0
0
Vandoeuvre-les-nancy
Query!
Country [179]
0
0
Germany
Query!
State/province [179]
0
0
Bad Krozingen
Query!
Country [180]
0
0
Germany
Query!
State/province [180]
0
0
Bad Rothenfelde
Query!
Country [181]
0
0
Germany
Query!
State/province [181]
0
0
Bad Segeberg
Query!
Country [182]
0
0
Germany
Query!
State/province [182]
0
0
Berlin
Query!
Country [183]
0
0
Germany
Query!
State/province [183]
0
0
Bielefeld
Query!
Country [184]
0
0
Germany
Query!
State/province [184]
0
0
Bochum
Query!
Country [185]
0
0
Germany
Query!
State/province [185]
0
0
Burg
Query!
Country [186]
0
0
Germany
Query!
State/province [186]
0
0
Coburg
Query!
Country [187]
0
0
Germany
Query!
State/province [187]
0
0
Darmstadt
Query!
Country [188]
0
0
Germany
Query!
State/province [188]
0
0
Dortmund
Query!
Country [189]
0
0
Germany
Query!
State/province [189]
0
0
Duisburg
Query!
Country [190]
0
0
Germany
Query!
State/province [190]
0
0
Essen
Query!
Country [191]
0
0
Germany
Query!
State/province [191]
0
0
Frankfurt am Main
Query!
Country [192]
0
0
Germany
Query!
State/province [192]
0
0
Frankfurt
Query!
Country [193]
0
0
Germany
Query!
State/province [193]
0
0
Führt
Query!
Country [194]
0
0
Germany
Query!
State/province [194]
0
0
Halle
Query!
Country [195]
0
0
Germany
Query!
State/province [195]
0
0
Hamburg
Query!
Country [196]
0
0
Germany
Query!
State/province [196]
0
0
Heidelberg
Query!
Country [197]
0
0
Germany
Query!
State/province [197]
0
0
Homburg/Saar
Query!
Country [198]
0
0
Germany
Query!
State/province [198]
0
0
Langen
Query!
Country [199]
0
0
Germany
Query!
State/province [199]
0
0
Limburg
Query!
Country [200]
0
0
Germany
Query!
State/province [200]
0
0
Mainz
Query!
Country [201]
0
0
Germany
Query!
State/province [201]
0
0
Mannheim
Query!
Country [202]
0
0
Germany
Query!
State/province [202]
0
0
Mönchengladbach
Query!
Country [203]
0
0
Germany
Query!
State/province [203]
0
0
Neuss
Query!
Country [204]
0
0
Germany
Query!
State/province [204]
0
0
Northeim
Query!
Country [205]
0
0
Germany
Query!
State/province [205]
0
0
Ruedersdorf
Query!
Country [206]
0
0
Germany
Query!
State/province [206]
0
0
Ulm
Query!
Country [207]
0
0
Germany
Query!
State/province [207]
0
0
Villingen-Schwenningen
Query!
Country [208]
0
0
Germany
Query!
State/province [208]
0
0
Witten
Query!
Country [209]
0
0
Germany
Query!
State/province [209]
0
0
Wuppertal
Query!
Country [210]
0
0
Grenada
Query!
State/province [210]
0
0
Toulouse
Query!
Country [211]
0
0
Hungary
Query!
State/province [211]
0
0
Baja
Query!
Country [212]
0
0
Hungary
Query!
State/province [212]
0
0
Bekescsaba
Query!
Country [213]
0
0
Hungary
Query!
State/province [213]
0
0
Budapest
Query!
Country [214]
0
0
Hungary
Query!
State/province [214]
0
0
Debrecen
Query!
Country [215]
0
0
Hungary
Query!
State/province [215]
0
0
Kalocsa
Query!
Country [216]
0
0
Hungary
Query!
State/province [216]
0
0
Kecskemet
Query!
Country [217]
0
0
Hungary
Query!
State/province [217]
0
0
Pecs
Query!
Country [218]
0
0
Hungary
Query!
State/province [218]
0
0
Sopron
Query!
Country [219]
0
0
Hungary
Query!
State/province [219]
0
0
Szeged
Query!
Country [220]
0
0
Hungary
Query!
State/province [220]
0
0
Szekszárd
Query!
Country [221]
0
0
Hungary
Query!
State/province [221]
0
0
Székesfehérvár
Query!
Country [222]
0
0
Hungary
Query!
State/province [222]
0
0
Zalaegerszeg
Query!
Country [223]
0
0
Ireland
Query!
State/province [223]
0
0
Dublin
Query!
Country [224]
0
0
Israel
Query!
State/province [224]
0
0
Afula
Query!
Country [225]
0
0
Israel
Query!
State/province [225]
0
0
Beer Sheva
Query!
Country [226]
0
0
Israel
Query!
State/province [226]
0
0
Givatayim
Query!
Country [227]
0
0
Israel
Query!
State/province [227]
0
0
Hadera
Query!
Country [228]
0
0
Israel
Query!
State/province [228]
0
0
Haifa
Query!
Country [229]
0
0
Israel
Query!
State/province [229]
0
0
Jerusalem
Query!
Country [230]
0
0
Israel
Query!
State/province [230]
0
0
Kfar Saba
Query!
Country [231]
0
0
Israel
Query!
State/province [231]
0
0
Nahariya
Query!
Country [232]
0
0
Israel
Query!
State/province [232]
0
0
Nazareth
Query!
Country [233]
0
0
Israel
Query!
State/province [233]
0
0
Petach Tikva
Query!
Country [234]
0
0
Israel
Query!
State/province [234]
0
0
Rehovot
Query!
Country [235]
0
0
Israel
Query!
State/province [235]
0
0
Tel Aviv
Query!
Country [236]
0
0
Israel
Query!
State/province [236]
0
0
Tel Hashomer
Query!
Country [237]
0
0
Israel
Query!
State/province [237]
0
0
Tiberias
Query!
Country [238]
0
0
Israel
Query!
State/province [238]
0
0
Zerifin
Query!
Country [239]
0
0
Italy
Query!
State/province [239]
0
0
Abruzzo
Query!
Country [240]
0
0
Italy
Query!
State/province [240]
0
0
Campania
Query!
Country [241]
0
0
Italy
Query!
State/province [241]
0
0
Emilia-Romagna
Query!
Country [242]
0
0
Italy
Query!
State/province [242]
0
0
Friuli-Venezia Giulia
Query!
Country [243]
0
0
Italy
Query!
State/province [243]
0
0
Lazio
Query!
Country [244]
0
0
Italy
Query!
State/province [244]
0
0
Liguria
Query!
Country [245]
0
0
Italy
Query!
State/province [245]
0
0
Lombardia
Query!
Country [246]
0
0
Italy
Query!
State/province [246]
0
0
Marche
Query!
Country [247]
0
0
Italy
Query!
State/province [247]
0
0
Piemonte
Query!
Country [248]
0
0
Italy
Query!
State/province [248]
0
0
Toscana
Query!
Country [249]
0
0
Italy
Query!
State/province [249]
0
0
Veneto
Query!
Country [250]
0
0
Korea, Republic of
Query!
State/province [250]
0
0
Busan
Query!
Country [251]
0
0
Korea, Republic of
Query!
State/province [251]
0
0
Daegu
Query!
Country [252]
0
0
Korea, Republic of
Query!
State/province [252]
0
0
Gangwon-Do
Query!
Country [253]
0
0
Korea, Republic of
Query!
State/province [253]
0
0
Gangwon-do
Query!
Country [254]
0
0
Korea, Republic of
Query!
State/province [254]
0
0
Gwangju
Query!
Country [255]
0
0
Korea, Republic of
Query!
State/province [255]
0
0
Gyeonggi-do
Query!
Country [256]
0
0
Korea, Republic of
Query!
State/province [256]
0
0
Incheon
Query!
Country [257]
0
0
Korea, Republic of
Query!
State/province [257]
0
0
Kyonggi-do
Query!
Country [258]
0
0
Korea, Republic of
Query!
State/province [258]
0
0
Seoul
Query!
Country [259]
0
0
Netherlands
Query!
State/province [259]
0
0
'S Hertogenbosch
Query!
Country [260]
0
0
Netherlands
Query!
State/province [260]
0
0
Alkmaar
Query!
Country [261]
0
0
Netherlands
Query!
State/province [261]
0
0
Almelo
Query!
Country [262]
0
0
Netherlands
Query!
State/province [262]
0
0
Amersfoort
Query!
Country [263]
0
0
Netherlands
Query!
State/province [263]
0
0
Amstelveen
Query!
Country [264]
0
0
Netherlands
Query!
State/province [264]
0
0
Amsterdam
Query!
Country [265]
0
0
Netherlands
Query!
State/province [265]
0
0
Arnhem
Query!
Country [266]
0
0
Netherlands
Query!
State/province [266]
0
0
Blaricum
Query!
Country [267]
0
0
Netherlands
Query!
State/province [267]
0
0
Breda
Query!
Country [268]
0
0
Netherlands
Query!
State/province [268]
0
0
Capelle AD Yssel
Query!
Country [269]
0
0
Netherlands
Query!
State/province [269]
0
0
Delft
Query!
Country [270]
0
0
Netherlands
Query!
State/province [270]
0
0
Den Helder
Query!
Country [271]
0
0
Netherlands
Query!
State/province [271]
0
0
Deventer
Query!
Country [272]
0
0
Netherlands
Query!
State/province [272]
0
0
Eindhoven
Query!
Country [273]
0
0
Netherlands
Query!
State/province [273]
0
0
Enschede
Query!
Country [274]
0
0
Netherlands
Query!
State/province [274]
0
0
Goes
Query!
Country [275]
0
0
Netherlands
Query!
State/province [275]
0
0
Groningen
Query!
Country [276]
0
0
Netherlands
Query!
State/province [276]
0
0
Haarlem
Query!
Country [277]
0
0
Netherlands
Query!
State/province [277]
0
0
Heerlen
Query!
Country [278]
0
0
Netherlands
Query!
State/province [278]
0
0
Hengelo
Query!
Country [279]
0
0
Netherlands
Query!
State/province [279]
0
0
Hilversum
Query!
Country [280]
0
0
Netherlands
Query!
State/province [280]
0
0
Hoofddorp
Query!
Country [281]
0
0
Netherlands
Query!
State/province [281]
0
0
Hoorn
Query!
Country [282]
0
0
Netherlands
Query!
State/province [282]
0
0
Leiden
Query!
Country [283]
0
0
Netherlands
Query!
State/province [283]
0
0
Leiderdorp
Query!
Country [284]
0
0
Netherlands
Query!
State/province [284]
0
0
Maastricht
Query!
Country [285]
0
0
Netherlands
Query!
State/province [285]
0
0
Nieuwegein
Query!
Country [286]
0
0
Netherlands
Query!
State/province [286]
0
0
Nijmegen
Query!
Country [287]
0
0
Netherlands
Query!
State/province [287]
0
0
Purmerend
Query!
Country [288]
0
0
Netherlands
Query!
State/province [288]
0
0
Rotterdam
Query!
Country [289]
0
0
Netherlands
Query!
State/province [289]
0
0
Sneek
Query!
Country [290]
0
0
Netherlands
Query!
State/province [290]
0
0
Stadskanaal
Query!
Country [291]
0
0
Netherlands
Query!
State/province [291]
0
0
Tilburg
Query!
Country [292]
0
0
Netherlands
Query!
State/province [292]
0
0
Utrecht
Query!
Country [293]
0
0
Netherlands
Query!
State/province [293]
0
0
Weert
Query!
Country [294]
0
0
Netherlands
Query!
State/province [294]
0
0
Zaandam
Query!
Country [295]
0
0
Netherlands
Query!
State/province [295]
0
0
Zwolle
Query!
Country [296]
0
0
New Zealand
Query!
State/province [296]
0
0
Auckland
Query!
Country [297]
0
0
New Zealand
Query!
State/province [297]
0
0
Christchurch
Query!
Country [298]
0
0
New Zealand
Query!
State/province [298]
0
0
Dunedin
Query!
Country [299]
0
0
New Zealand
Query!
State/province [299]
0
0
Hamilton
Query!
Country [300]
0
0
New Zealand
Query!
State/province [300]
0
0
Nelson
Query!
Country [301]
0
0
New Zealand
Query!
State/province [301]
0
0
New Plymouth
Query!
Country [302]
0
0
New Zealand
Query!
State/province [302]
0
0
Wellington
Query!
Country [303]
0
0
Poland
Query!
State/province [303]
0
0
Bialystok
Query!
Country [304]
0
0
Poland
Query!
State/province [304]
0
0
Bydgoszcz
Query!
Country [305]
0
0
Poland
Query!
State/province [305]
0
0
Elblag
Query!
Country [306]
0
0
Poland
Query!
State/province [306]
0
0
Gdansk
Query!
Country [307]
0
0
Poland
Query!
State/province [307]
0
0
Gdynia
Query!
Country [308]
0
0
Poland
Query!
State/province [308]
0
0
Grodzisk Mazowiecki
Query!
Country [309]
0
0
Poland
Query!
State/province [309]
0
0
Inowroclaw
Query!
Country [310]
0
0
Poland
Query!
State/province [310]
0
0
Katowice
Query!
Country [311]
0
0
Poland
Query!
State/province [311]
0
0
Krakow
Query!
Country [312]
0
0
Poland
Query!
State/province [312]
0
0
Lodz
Query!
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Funding & Sponsors
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Hoffmann-La Roche
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Summary
Brief summary
This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS) and evaluate the long term safety profile of the drug. Eligible patients in stable condition will be randomized to receive either RO4607381 600mg po or placebo po, daily, together with a background of standard medication for ACS (including aspirin, antihypertensives and statins). The anticipated time on study treatment is 2+ years, and the target sample size is 15,600 individuals.
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Trial website
https://clinicaltrials.gov/study/NCT00658515
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Trial related presentations / publications
Schwartz GG, Leiter LA, Ballantyne CM, Barter PJ, Black DM, Kallend D, Laghrissi-Thode F, Leitersdorf E, McMurray JJV, Nicholls SJ, Olsson AG, Preiss D, Shah PK, Tardif JC, Kittelson J. Dalcetrapib Reduces Risk of New-Onset Diabetes in Patients With Coronary Heart Disease. Diabetes Care. 2020 May;43(5):1077-1084. doi: 10.2337/dc19-2204. Epub 2020 Mar 6. Salahuddin T, Kittelson J, Tardif JC, Shah PK, Olsson AG, Nicholls SJ, Leitersdorf E, Leiter LA, Kallend D, Black DM, Barter PJ, Ballantyne CM, Schwartz GG. Association of high-density lipoprotein particle concentration with cardiovascular risk following acute coronary syndrome: A case-cohort analysis of the dal-Outcomes trial. Am Heart J. 2020 Mar;221:60-66. doi: 10.1016/j.ahj.2019.12.003. Epub 2019 Dec 16. Schwartz GG, Ballantyne CM, Barter PJ, Kallend D, Leiter LA, Leitersdorf E, McMurray JJV, Nicholls SJ, Olsson AG, Shah PK, Tardif JC, Kittelson J. Association of Lipoprotein(a) With Risk of Recurrent Ischemic Events Following Acute Coronary Syndrome: Analysis of the dal-Outcomes Randomized Clinical Trial. JAMA Cardiol. 2018 Feb 1;3(2):164-168. doi: 10.1001/jamacardio.2017.3833. Pitts R, Gunzburger E, Ballantyne CM, Barter PJ, Kallend D, Leiter LA, Leitersdorf E, Nicholls SJ, Shah PK, Tardif JC, Olsson AG, McMurray JJ, Kittelson J, Schwartz GG. Aldosterone Does Not Predict Cardiovascular Events Following Acute Coronary Syndrome in Patients Initially Without Heart Failure. J Am Heart Assoc. 2017 Jan 10;6(1):e004119. doi: 10.1161/JAHA.116.004119. Tardif JC, Rhainds D, Brodeur M, Feroz Zada Y, Fouodjio R, Provost S, Boule M, Alem S, Gregoire JC, L'Allier PL, Ibrahim R, Guertin MC, Mongrain I, Olsson AG, Schwartz GG, Rheaume E, Dube MP. Genotype-Dependent Effects of Dalcetrapib on Cholesterol Efflux and Inflammation: Concordance With Clinical Outcomes. Circ Cardiovasc Genet. 2016 Aug;9(4):340-8. doi: 10.1161/CIRCGENETICS.116.001405. Epub 2016 Jul 14. Schwartz GG, Abt M, Bao W, DeMicco D, Kallend D, Miller M, Mundl H, Olsson AG. Fasting triglycerides predict recurrent ischemic events in patients with acute coronary syndrome treated with statins. J Am Coll Cardiol. 2015 Jun 2;65(21):2267-75. doi: 10.1016/j.jacc.2015.03.544. Erratum In: J Am Coll Cardiol. 2015 Jul 21;66(3):334. Tardif JC, Rheaume E, Lemieux Perreault LP, Gregoire JC, Feroz Zada Y, Asselin G, Provost S, Barhdadi A, Rhainds D, L'Allier PL, Ibrahim R, Upmanyu R, Niesor EJ, Benghozi R, Suchankova G, Laghrissi-Thode F, Guertin MC, Olsson AG, Mongrain I, Schwartz GG, Dube MP. Pharmacogenomic determinants of the cardiovascular effects of dalcetrapib. Circ Cardiovasc Genet. 2015 Apr;8(2):372-82. doi: 10.1161/CIRCGENETICS.114.000663. Epub 2015 Jan 11. Schwartz GG, Olsson AG, Abt M, Ballantyne CM, Barter PJ, Brumm J, Chaitman BR, Holme IM, Kallend D, Leiter LA, Leitersdorf E, McMurray JJ, Mundl H, Nicholls SJ, Shah PK, Tardif JC, Wright RS; dal-OUTCOMES Investigators. Effects of dalcetrapib in patients with a recent acute coronary syndrome. N Engl J Med. 2012 Nov 29;367(22):2089-99. doi: 10.1056/NEJMoa1206797. Epub 2012 Nov 5. Luscher TF, Taddei S, Kaski JC, Jukema JW, Kallend D, Munzel T, Kastelein JJ, Deanfield JE; dal-VESSEL Investigators. Vascular effects and safety of dalcetrapib in patients with or at risk of coronary heart disease: the dal-VESSEL randomized clinical trial. Eur Heart J. 2012 Apr;33(7):857-65. doi: 10.1093/eurheartj/ehs019. Epub 2012 Feb 16. Derks M, Abt M, Parr G, Meneses-Lorente G, Young AM, Phelan M. No clinically relevant drug-drug interactions when dalcetrapib is co-administered with atorvastatin. Expert Opin Investig Drugs. 2010 Oct;19(10):1135-45. doi: 10.1517/13543784.2010.509342. Schwartz GG, Olsson AG, Ballantyne CM, Barter PJ, Holme IM, Kallend D, Leiter LA, Leitersdorf E, McMurray JJ, Shah PK, Tardif JC, Chaitman BR, Duttlinger-Maddux R, Mathieson J; dal-OUTCOMES Committees and Investigators. Rationale and design of the dal-OUTCOMES trial: efficacy and safety of dalcetrapib in patients with recent acute coronary syndrome. Am Heart J. 2009 Dec;158(6):896-901.e3. doi: 10.1016/j.ahj.2009.09.017. Stein EA, Stroes ES, Steiner G, Buckley BM, Capponi AM, Burgess T, Niesor EJ, Kallend D, Kastelein JJ. Safety and tolerability of dalcetrapib. Am J Cardiol. 2009 Jul 1;104(1):82-91. doi: 10.1016/j.amjcard.2009.02.061.
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Results are available at
https://clinicaltrials.gov/study/NCT00658515
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