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Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events (DECLARE-TIMI58)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Bristol-Myers Squibb
The TIMI Study Group
Hadassah Medical Organization
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01730534
First received: November 15, 2012
Last updated: June 19, 2017
Last verified: June 2017
  Purpose
This study is being carried out to determine the effect of dapagliflozin on cardiovacular outcomes when added to current background therapy in patients with type 2 diabetes with either established cardiovacular disease or cardiovascular risk factors.

Condition Intervention Phase
Diabetes Mellitus, Non-Insulin-Dependent High Risk for Cardiovascular Event Drug: Dapagliflozin 10 mg Drug: Placebo tablet Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dapagliflozin Effect on Cardiovascular Events A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin 10 mg Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to first event included in the composite endpoint of CV death, MI or ischemic stroke [ Time Frame: up to 6 years ]
    Safety and co-primary efficacy

  • Time to first event included in the composite endpoint of CV death or hospitalization due to heart failure. [ Time Frame: up to 6 years ]
    Co-primary efficacy


Secondary Outcome Measures:
  • Time to first event of renal composite endpoint: Confirmed sustained ≥40% decrease in eGFR to eGFR <60 ml/min/1.73m2 and/or ESRD and/or renal or CV death [ Time Frame: up to 6 years ]
  • Time to All-cause mortality [ Time Frame: up to 6 years ]

Enrollment: 17276
Actual Study Start Date: April 25, 2013
Estimated Study Completion Date: April 29, 2019
Estimated Primary Completion Date: April 29, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dapagliflozin
Dapagliflozin + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors
Drug: Dapagliflozin 10 mg
Oral dose (od)
Placebo Comparator: Placebo
Placebo + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors
Drug: Placebo tablet
Oral dose (od)

  Eligibility

Ages Eligible for Study:   40 Years to 130 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures
  • Female or male aged ≥40 years
  • Diagnosed with Type 2 Diabetes
  • High Risk for Cardiovascular events

Exclusion Criteria:

  • Diagnosis of Type 1 diabetes mellitus History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
  • Chronic cystitis and/or recurrent urinary tract infections
  • Pregnant or breast-feeding patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730534

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United States, Alabama
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Alexander City, Alabama, United States, 35010
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Athens, Alabama, United States, 35611
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Ostrava-Moravska, Czechia, 702 00
Research Site
Plzen - Severni Predmesti, Czechia, 301 00
Research Site
Plzen, Czechia, 30100
Research Site
Praha 4, Czechia, 140 46
Research Site
Praha 5, Czechia, 154 00
Research Site
Praha 6, Czechia, 163 00
Research Site
Praha, Czechia, 152 00
Research Site
Prelouc, Czechia, 535 01
Research Site
Rakovnik, Czechia, 269 01
Research Site
Slany, Czechia, 274 01
Research Site
Teplice, Czechia, 415 01
Research Site
Uherske Hradiste, Czechia, 686 01
Research Site
Usti nad Labem, Czechia, 400 01
Research Site
Zlin, Czechia, 760 01
France
Research Site
Angers cedex 9, France, 49033
Research Site
Corbeil-Essonnes, France, 91100
Research Site
Dijon Cedex, France, 21079
Research Site
Dijon, France, 21079
Research Site
La Rochelle, France, 17019
Research Site
Le Creusot, France, 71206
Research Site
Nantes Cedex 1, France, 44093
Research Site
Nantes Cedex 2, France, 44277
Research Site
Pessac, France, 33604
Research Site
Poitiers Cedex, France, 86021
Research Site
TOULOUSE Cedex 9, France, 31059
Germany
Research Site
Aschaffenburg, Germany, 63739
Research Site
Bad Mergentheim, Germany, 97980
Research Site
Bad Oeynhausen, Germany, 32545
Research Site
Berlin, Germany, 10115
Research Site
Berlin, Germany, 12559
Research Site
Berlin, Germany, 13347
Research Site
Dippoldiswalde, Germany, 01744
Research Site
Freiburg, Germany, 79106
Research Site
Hamburg, Germany, 22391
Research Site
Kassel, Germany, 34121
Research Site
Köln, Germany, 51069
Research Site
Leipzig, Germany, 04103
Research Site
München, Germany, 80333
Research Site
Villingen-Schwenningen, Germany, 78048
Hong Kong
Research Site
Causeway Bay, Hong Kong
Research Site
Hongkong, Hong Kong
Research Site
Tai Po, Hong Kong
Hungary
Research Site
Balatonfüred, Hungary, 8230
Research Site
Ballasagyarmat, Hungary, 2660
Research Site
Berettyóújfalu, Hungary, 4100
Research Site
Budapest, Hungary, 1032
Research Site
Budapest, Hungary, 1096
Research Site
Budapest, Hungary, 1106
Research Site
Budapest, Hungary, 1125
Research Site
Budapest, Hungary, 1135
Research Site
Budapest, Hungary, 1171
Research Site
Budapest, Hungary, 1212
Research Site
Cegléd, Hungary, 2700
Research Site
Csongrád, Hungary, 6640
Research Site
Debrecen, Hungary, 4025
Research Site
Debrecen, Hungary, 4031
Research Site
Debrecen, Hungary, 4032
Research Site
Eger, Hungary, 3300
Research Site
Esztergom, Hungary, 2500
Research Site
Gyor, Hungary, 9024
Research Site
Gyöngyös, Hungary, 3200
Research Site
Kecskemét, Hungary, 6000
Research Site
Kistarcsa, Hungary, 2143
Research Site
Komárom, Hungary, 2921
Research Site
Mórahalom, Hungary, 6782
Research Site
Nyíregyháza, Hungary, 4400
Research Site
Polgár, Hungary, 4090
Research Site
Sopron, Hungary, 9400
Research Site
Szolnok, Hungary, 5004
Research Site
Székesfehérvár, Hungary, 8000
Research Site
Tát, Hungary, 2534
Research Site
Zalaegerszeg, Hungary, 8900
Research Site
Ács, Hungary, 2941
India
Research Site
Ahmedabad, India, 380060
Research Site
Bangalore, India, 560002
Research Site
Bangalore, India, 560034
Research Site
Pune, India, 411 011
Research Site
Vellore, India, 632004
Israel
Research Site
Afula, Israel, 18101
Research Site
Ashkelon, Israel, 78278
Research Site
Beer Sheva, Israel, 84350
Research Site
Bnei Barak, Israel, 5136166
Research Site
Hadera, Israel, 38100
Research Site
Haifa, Israel, 31096
Research Site
Haifa, Israel, 34362
Research Site
Haifa, Israel, 35152
Research Site
Holon, Israel, 58100
Research Site
Jerusalem, Israel, 91120
Research Site
Jerusalem, Israel, 93106
Research Site
Naharia, Israel, 22100
Research Site
Petach Tikva, Israel, 49100
Italy
Research Site
Bergamo, Italy, 24100
Research Site
Firenze, Italy, 50141
Research Site
Milano, Italy, 20132
Research Site
Milano, Italy, 20138
Research Site
Milano, Italy, 20162
Research Site
Napoli, Italy, 80131
Research Site
Negrar - VR, Italy, 37024
Research Site
Padova, Italy, 35128
Research Site
Parma, Italy, 43100
Research Site
Pavia, Italy, 27100
Research Site
Rozzano, Italy, 20089
Research Site
S Maria Capua Vetere, Italy, 81055
Research Site
Sessa Aurunca, Italy, 81037
Research Site
Verona, Italy, 37126
Japan
Research Site
Bunkyo-ku, Japan, 113-8655
Research Site
Daito-shi, Japan, 574-0074
Research Site
Kasuga-shi, Japan, 816-0864
Research Site
Kobe-shi, Japan, 655-0017
Research Site
Kumamoto-shi, Japan, 860-8556
Research Site
Matsubara-shi, Japan, 580-0032
Research Site
Saga-shi, Japan, 849-8501
Research Site
Ube-shi, Japan, 755-8505
Research Site
Uji-shi, Japan, 611-0041
Research Site
Yao-shi, Japan, 581-0011
Research Site
Yokohama-shi, Japan, 236-0004
Korea, Republic of
Research Site
Bucheon-si, Korea, Republic of, 420-717
Research Site
Busan, Korea, Republic of, 47392
Research Site
Cheongju-si, Korea, Republic of, 361-711
Research Site
Daegu, Korea, Republic of, 41944
Research Site
Daegu, Korea, Republic of, 705-718
Research Site
Daejeon, Korea, Republic of, 301721
Research Site
Goyang-si, Korea, Republic of, 10444
Research Site
Guri, Gyeonggi-do, Korea, Republic of, 471701
Research Site
Jeonju-si, Jeollabuk-do, Korea, Republic of, 561-71
Research Site
Seongnam-si, Korea, Republic of, 13620
Research Site
Seoul, Korea, Republic of, 02841
Research Site
Seoul, Korea, Republic of, 03080
Research Site
Seoul, Korea, Republic of, 05505
Research Site
Seoul, Korea, Republic of, 06591
Research Site
Seoul, Korea, Republic of, 110746
Research Site
Seoul, Korea, Republic of, 120752
Research Site
Seoul, Korea, Republic of, 135710
Research Site
Suwon, Korea, Republic of, 16499
Research Site
Uijeongbu-si, Korea, Republic of, 480717
Mexico
Research Site
Acapulco, Mexico, 39670
Research Site
Culiacan, Mexico, 80230
Research Site
Del. Cuauhtemoc, Mexico, 06700
Research Site
Distrito Federal, Mexico, 07760
Research Site
Distrito Federal, Mexico, 14000
Research Site
Guadalajara, Mexico, 44150
Research Site
Guadalajara, Mexico, 44160
Research Site
Guadalajara, Mexico, 44600
Research Site
Guadalajara, Mexico, 44670
Research Site
Meridas, Mexico, 97070
Research Site
Mexico, Mexico, 11560
Research Site
Mexico, Mexico, 11850
Research Site
Monterey, Mexico, 64060
Research Site
Monterrey, Mexico, 64460
Research Site
Monterrey, Mexico, 64620
Research Site
Pachuca de Soto, Mexico, 42090
Research Site
Queretaro, Mexico, 76000
Research Site
San Luis Potosi, Mexico, 78200
Research Site
Tijuana, Mexico, 22210
Research Site
Veracruz, Mexico, 91910
Research Site
Xalapa, Mexico, 91193
Research Site
Zapopan, Jalisco, Mexico, 45200
Research Site
Zapopan, Mexico, 45116
Netherlands
Research Site
Alkmaar, Netherlands, 1815JD
Research Site
Amsterdam, Netherlands, 1105 AZ
Research Site
Apeldoorn, Netherlands, 7334 DZ
Research Site
Arnhem, Netherlands, 6815 AD
Research Site
Breda, Netherlands, 4818 CK
Research Site
Delft, Netherlands, 2625 AD
Research Site
Den Haag, Netherlands, 2597 AX
Research Site
EDE, Netherlands, 6716 RP
Research Site
Eindhoven, Netherlands, 5631 BM
Research Site
Gouda, Netherlands, 2803 HH
Research Site
Groningen, Netherlands, 9728 NT
Research Site
Haarlem, Netherlands, 2035 RC
Research Site
Hardenberg, Netherlands, 7772 SE
Research Site
Heerlen, Netherlands, 6419 PC
Research Site
Hoogeveen, Netherlands, 7909 AA
Research Site
Nijmegen, Netherlands, 6532 SZ
Research Site
Rotterdam, Netherlands, 3021 HC
Research Site
Rotterdam, Netherlands, 3045 PM
Research Site
Sliedrecht, Netherlands, 3361 XV
Research Site
Sneek, Netherlands, 8601 ZR
Research Site
Utrecht, Netherlands, 3584 CX
Research Site
Venlo, Netherlands, 5912 BL
Research Site
Zutphen, Netherlands, 7207 AE
Philippines
Research Site
Bacolod, Philippines, 6100
Research Site
Cebu City, Philippines, 6000
Research Site
Dasmarinas City, Philippines, 4114
Research Site
Iloilo City, Philippines, 5000
Research Site
Lipa City, Philippines, 4217
Research Site
Makati City, Philippines, 1218
Research Site
Mandaluyong City, Philippines, 1554
Research Site
Manila, Philippines, 1003
Research Site
Manila, Philippines, 1008
Research Site
Manila, Philippines
Research Site
Marikina City, Philippines, 1810
Research Site
Pasay City, Philippines, 1300
Research Site
Pasig City, Philippines, 1605
Research Site
Quezon City, Philippines, 1100
Research Site
Quezon City, Philippines, 1101
Research Site
Quezon City, Philippines, 1104
Research Site
Quezon City, Philippines, 1112
Research Site
Tanauan City, Philippines, 4232
Poland
Research Site
Biała Rawska, Poland, 96-230
Research Site
Bydgoszcz, Poland, 85-681
Research Site
ChrzanÓw, Poland, 32-500
Research Site
Gdansk, Poland, 80-858
Research Site
Gdańsk, Poland, 80-952
Research Site
Gdynia, Poland, 81-423
Research Site
Giżycko, Poland, 11-500
Research Site
Katowice, Poland, 40-084
Research Site
Koluszki, Poland, 95-040
Research Site
Krakow, Poland, 31-121
Research Site
Kraków, Poland, 30-015
Research Site
Legnica, Poland, 59-220
Research Site
Lublin, Poland, 20-044
Research Site
Mrągowo, Poland, 11-700
Research Site
Nakło nad Notecią, Poland, 89-100
Research Site
Poznan, Poland, 61-289
Research Site
Poznan, Poland, 61655
Research Site
Płock, Poland, 09-402
Research Site
Ruda Śląska, Poland, 41-709
Research Site
Skierniewice, Poland, 96-100
Research Site
Sobótka, Poland, 55-050
Research Site
Sokółka, Poland, 16-100
Research Site
Torun, Poland, 87-100
Research Site
Toruń, Poland, 87-100
Research Site
Warszawa, Poland, 02-679
Research Site
Warszawa, Poland, 03-973
Research Site
Wierzchosławice, Poland, 33-122
Research Site
Wrocław, Poland, 50-403
Research Site
Wrocław, Poland, 50-981
Research Site
Węgrów, Poland, 07-100
Research Site
Włocławek, Poland, 87-800
Research Site
Zabrze, Poland, 41 800
Research Site
Łęczna, Poland, 21-010
Romania
Research Site
Bacau, Romania, 600114
Research Site
Bacau, Romania, 600164
Research Site
Bucharest, Romania, 010507
Research Site
Bucharest, Romania, 020475
Research Site
Bucharest, Romania, 020614
Research Site
Bucuresti, Romania, 011234
Research Site
Bucuresti, Romania, 020048
Research Site
Bucuresti, Romania, 020359
Research Site
Bucuresti, Romania, 20048
Research Site
Cluj Napoca, Romania, 400006
Research Site
Cluj Napoca, Romania, 400353
Research Site
Constanta, Romania, 900675
Research Site
Galati, Romania, 800371
Research Site
Iasi, Romania, 700400
Research Site
Iasi, Romania, 700515
Research Site
Iasi, Romania, 700613
Research Site
Iasi, Romania, 700732
Research Site
Ploiesti, Romania, 100163
Research Site
Sibiu, Romania, 550371
Research Site
Timisoara, Romania, 300125
Research Site
Tirgu Mures, Romania, 540013
Research Site
Târgu Mures, Romania, 540136
Research Site
Zalau, Romania, 450129
Russian Federation
Research Site
Arkhangelsk, Russian Federation, 163001
Research Site
Chelyabinsk, Russian Federation, 454091
Research Site
Chelyabinsk, Russian Federation, 454106
Research Site
Ivanovo, Russian Federation, 153012
Research Site
Izhevsk, Russian Federation, 426063
Research Site
Kazan, Russian Federation, 420012
Research Site
Kazan, Russian Federation, 420029
Research Site
Moscow, Russian Federation, 101990
Research Site
Moscow, Russian Federation, 117292
Research Site
Moscow, Russian Federation, 119034
Research Site
Moscow, Russian Federation, 121552
Research Site
Moscow, Russian Federation, 125367
Research Site
Moscow, Russian Federation, 127473
Research Site
Moscow, Russian Federation, 129110
Research Site
Moscow, Russian Federation, 129301
Research Site
Nizhnii Novgorod, Russian Federation, 603018
Research Site
Novosibirsk, Russian Federation, 630008
Research Site
Perm, Russian Federation, 6144090
Research Site
Rostov-on-Don, Russian Federation, 344022
Research Site
Saint Petersburg, Russian Federation, 193312
Research Site
Saint Petersburg, Russian Federation, 194044
Research Site
Saint Petersburg, Russian Federation, 194354
Research Site
Saint Petersburg, Russian Federation, 195257
Research Site
Saint Petersburg, Russian Federation, 198217
Research Site
Saint Petersburg, Russian Federation, 198328
Research Site
Saint- Petersburg, Russian Federation, 192148
Research Site
Saint-Petersburg, Russian Federation, 199106
Research Site
Saratov, Russian Federation, 410053
Research Site
Tver, Russian Federation, 170036
Research Site
Ufa, Russian Federation, 450071
Research Site
Vladikavkaz, Russian Federation, 362027
Research Site
Volgograd, Russian Federation, 400005
Research Site
Yekaterinburg, Russian Federation, 620039
Slovakia
Research Site
Banská Bystrica, Slovakia, 97401
Research Site
Bratislava, Slovakia, 81108
Research Site
Bratislava, Slovakia, 83301
Research Site
Dolný Kubín, Slovakia, 02601
Research Site
Kosice, Slovakia, 04011
Research Site
Kosice, Slovakia, 04022
Research Site
Košice, Slovakia, 04001
Research Site
Levice, Slovakia, 934 01
Research Site
Lučenec, Slovakia, 98401
Research Site
Nove Zamky, Slovakia, 94001
Research Site
Námestovo, Slovakia, 02901
Research Site
Piešťany, Slovakia, 92101
Research Site
Poprad, Slovakia, 058 01
Research Site
Povazska Bystrica, Slovakia, 01701
Research Site
Prievidza, Slovakia, 97101
Research Site
Rimavská Sobota, Slovakia, 97901
Research Site
Sabinov, Slovakia, 083 01
Research Site
Sala, Slovakia, 927 01
Research Site
Trebišov, Slovakia, 07501
Research Site
Trenčín, Slovakia, 91101
Research Site
Vrutky, Slovakia, 038 61
Research Site
Žilina, Slovakia, 01001
South Africa
Research Site
Alberton, South Africa, 1450
Research Site
Benoni, South Africa, 1500
Research Site
Cape Town, South Africa, 7405
Research Site
Cape Town, South Africa, 7500
Research Site
Cape Town, South Africa, 7505
Research Site
Diepkloof, Soweto, South Africa, 2013
Research Site
Durban, South Africa, 4001
Research Site
Durban, South Africa, 4052
Research Site
Goodwood, South Africa, 7460
Research Site
Houghton, South Africa, 2198
Research Site
Muckleneuk, South Africa, 0002
Research Site
Parktown West, South Africa, 2193
Research Site
Parktown, South Africa, 2193
Research Site
Phoenix, South Africa, 4068
Research Site
Somerset West, South Africa, 7130
Research Site
Verulam, South Africa, 4345
Research Site
Worcester, South Africa, 6850
Spain
Research Site
Almeria, Spain, 04120
Research Site
Barcelona, Spain, 08003
Research Site
Barcelona, Spain, 08041
Research Site
L'Hospitalet de Llobregat, Spain, 08907
Research Site
Madrid, Spain, 28046
Research Site
Madrid, Spain, 28049
Research Site
Oviedo, Spain, 33011
Research Site
Sant Joan Despi, Spain, 08970
Research Site
Santiago de Compostela, Spain, 15706
Research Site
Sevilla, Spain, 41071
Sweden
Research Site
Borås, Sweden, 506 30
Research Site
Eksjö, Sweden, 57535
Research Site
Finspång, Sweden, 612 37
Research Site
Gothenburg, Sweden, 41345
Research Site
Gothenburg, Sweden, 41685
Research Site
Järfälla, Sweden, 177 30
Research Site
Linköping, Sweden, 589 29
Research Site
Lund, Sweden, 222 21
Research Site
Malmo, Sweden, 21152
Research Site
Ostersund, Sweden, 831 83
Research Site
Rättvik, Sweden, 79530
Research Site
Stockholm, Sweden, 111 57
Research Site
Stockholm, Sweden, 117 28
Research Site
Stockholm, Sweden, 171 76
Research Site
Umeå, Sweden, 907 36
Research Site
Vällingby, Sweden, 162 68
Taiwan
Research Site
Changhua, Taiwan, 50006
Research Site
Kaohsiung, Taiwan, 80756
Research Site
Kaohsiung, Taiwan, 83301
Research Site
Taichung City, Taiwan, 40201
Research Site
Taichung, Taiwan, 40705
Research Site
Taipei, Taiwan, 11217
Thailand
Research Site
Bangkok, Thailand, 10330
Research Site
Bangkok, Thailand, 10400
Research Site
Bangkok, Thailand, 10700
Research Site
Chiang Mai, Thailand, 50200
Research Site
Muang, Thailand, 40002
Research Site
Nakhon Ratchasima, Thailand, 30000
Research Site
Pathumthani, Thailand, 12120
Research Site
Phisanulok, Thailand, 65000
Research Site
Rajthevi, Thailand, 10400
Research Site
Ratchaburi, Thailand, 70000
Research Site
Ratchathewi, Thailand, 10400
Turkey
Research Site
Antalya, Turkey, 07058
Research Site
Istanbul, Turkey, 34093
Research Site
Istanbul, Turkey, 34360
Research Site
Istanbul, Turkey, 34730
Research Site
Istanbul, Turkey, 34865
Research Site
Izmir, Turkey, 35100
Research Site
İzmir, Turkey, 35210
Ukraine
Research Site
Dnepropetrovsk, Ukraine, 49006
Research Site
Dnipropetrovsk, Ukraine, 49038
Research Site
Donetsk, Ukraine, 83003
Research Site
Kharkiv, Ukraine, 61176
Research Site
Kharkov, Ukraine, 61018
Research Site
Kiev, Ukraine, 02176
Research Site
Kiev, Ukraine, 03015
Research Site
Kyiv, Ukraine, 01601
Research Site
Kyiv, Ukraine, 04114
Research Site
Vinnytsia, Ukraine, 21001
Research Site
Vynnitsa, Ukraine, 21018
Research Site
Zaporizhzhya, Ukraine, 69118
Research Site
Zaporozhye, Ukraine, 69001
United Kingdom
Research Site
Addlestone, United Kingdom, KT15 2BH
Research Site
Aylesbury, United Kingdom, HP22 5LB
Research Site
Bath, United Kingdom, BA3 2UH
Research Site
Belfast, United Kingdom, BT13 3BW
Research Site
Belfast, United Kingdom, BT7 2EB
Research Site
Blackpool, United Kingdom, FY4 3AD
Research Site
Canterbury, United Kingdom, CT1 3HX
Research Site
Corsham, United Kingdom, SN13 9DL
Research Site
Coventry, United Kingdom, CV6 4DD
Research Site
Glasgow, United Kingdom, G69 7AD
Research Site
Irvine, United Kingdom, KA12 0AY
Research Site
Leicester, United Kingdom, LE10 2SE
Research Site
Mortimer Reading, United Kingdom, RG7 3SQ
Research Site
Sheffield, United Kingdom, S35 9XQ
Research Site
Whitstable, United Kingdom, CT5 3SE
Vietnam
Research Site
Hanoi, Vietnam, 100000
Research Site
Ho Chi Minh City, Vietnam, 70000
Research Site
Ho Chi Minh City, Vietnam, 9000
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
The TIMI Study Group
Hadassah Medical Organization
Investigators
Study Director: Anna Maria Langkilde, MD AstraZeneca Sweden
Study Chair: Marc S Sabatine, MD, MPH TIMI Study Group, Boston, MA, USA
Principal Investigator: Itamar Raz, MD Hadassah Medical Organization
Principal Investigator: Stephen D Wiviott, MD TIMI Study Group, MA, USA
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01730534     History of Changes
Other Study ID Numbers: D1693C00001
Study First Received: November 15, 2012
Last Updated: June 19, 2017

Keywords provided by AstraZeneca:
Phase IIIb
T2DM
cardiovascular events

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 22, 2017