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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by AstraZeneca
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: September 30, 2014
Last verified: September 2014
  Purpose

This study is being carried out to see if dapagliflozin when added to a patients current anti-diabetes therapy is effective in reducing cardiovascular events such as myocardial infarction (MI) (heart attack), ischemic stroke, and cardiovascular (CV) related death, compared with placebo (inactive study medication).


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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first event of Hospitalization for Congestive Heart Failure [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  • Time to first event included in the composite endpoint of CV death, MI, ischemic stroke, hospitalization for heart failure, hospitalization for unstable angina pectoris, or hospitalization for any revascularization [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  • Time to All-cause mortality [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  • Body weight change from baseline [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 17150
Study Start Date: April 2013
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 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)

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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

Contacts
Contact: AstraZeneca Clinical Study Information 800-236-9933 ClinicalTrialTransparency@astrazeneca.com

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Canada, Newfoundland and Labrador
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Bay Roberts, Newfoundland and Labrador, Canada
Research Site Recruiting
Mount Pearl, Newfoundland and Labrador, Canada
Research Site Recruiting
St. John's, Newfoundland and Labrador, Canada
Canada, Nova Scotia
Research Site Recruiting
Halifax, Nova Scotia, Canada
Research Site Recruiting
Sydney Mines, Nova Scotia, Canada
Canada, Ontario
Research Site Recruiting
Brampton, Ontario, Canada
Research Site Recruiting
Cambridge, Ontario, Canada
Research Site Recruiting
London, Ontario, Canada
Research Site Recruiting
North York, Ontario, Canada
Research Site Recruiting
Oakville, Ontario, Canada
Research Site Recruiting
Oshawa, Ontario, Canada
Research Site Withdrawn
Ottawa, Ontario, Canada
Research Site Recruiting
Scarborough, Ontario, Canada
Research Site Recruiting
Smiths Falls, Ontario, Canada
Research Site Recruiting
Thornhill, Ontario, Canada
Research Site Recruiting
Toronto, Ontario, Canada
Canada, Quebec
Research Site Recruiting
Chicoutimi, Quebec, Canada
Research Site Recruiting
Laval, Quebec, Canada
Research Site Recruiting
Levis, Quebec, Canada
Research Site Recruiting
Longueuil, Quebec, Canada
Research Site Recruiting
Montreal, Quebec, Canada
Research Site Withdrawn
Montreal, Quebec, Canada
Research Site Recruiting
Montréal, Quebec, Canada
Research Site Recruiting
Pointe-Claire, Quebec, Canada
Research Site Recruiting
Saint-Charles-Borromee, Quebec, Canada
Research Site Recruiting
Saint-Georges, Quebec, Canada
Research Site Recruiting
Sherbrooke, Quebec, Canada
Research Site Recruiting
Terrebonne, Quebec, Canada
Canada, Saskatchewan
Research Site Recruiting
Regina, Saskatchewan, Canada
Research Site Recruiting
Saskatoon, Saskatchewan, Canada
Canada
Research Site Recruiting
Quebec, Canada
Czech Republic
Research Site Recruiting
Beroun, Czech Republic
Research Site Recruiting
Brno, Czech Republic
Research Site Withdrawn
Caslav, Czech Republic
Research Site Recruiting
Cheb, Czech Republic
Research Site Recruiting
Chomutov, Czech Republic
Research Site Recruiting
Chrudim III, Czech Republic
Research Site Recruiting
Hodonin, Czech Republic
Research Site Recruiting
Horovice, Czech Republic
Research Site Recruiting
Hradec Kralove, Czech Republic
Research Site Recruiting
Jilove u Prahy, Czech Republic
Research Site Recruiting
Kromeriz, Czech Republic
Research Site Withdrawn
Mlada Boleslav, Czech Republic
Research Site Recruiting
Ostrava - Belsky les, Czech Republic
Research Site Recruiting
Ostrava - Kuncice, Czech Republic
Research Site Recruiting
Ostrava - Vitkovice, Czech Republic
Research Site Recruiting
Ostrava-Moravska, Czech Republic
Research Site Withdrawn
Pelhrimov, Czech Republic
Research Site Recruiting
Plzen, Czech Republic
Research Site Recruiting
Plzen - Severni Predmesti, Czech Republic
Research Site Recruiting
Praha, Czech Republic
Research Site Withdrawn
Praha - Klanovice, Czech Republic
Research Site Recruiting
Praha 4, Czech Republic
Research Site Not yet recruiting
Praha 4, Czech Republic
Research Site Recruiting
Praha 5, Czech Republic
Research Site Withdrawn
Praha 5, Czech Republic
Research Site Recruiting
Praha 6, Czech Republic
Research Site Recruiting
Prelouc, Czech Republic
Research Site Recruiting
Rakovnik, Czech Republic
Research Site Recruiting
Slany, Czech Republic
Research Site Recruiting
Teplice, Czech Republic
Research Site Recruiting
Uherske Hradiste, Czech Republic
Research Site Recruiting
Usti nad Labem, Czech Republic
Research Site Recruiting
Zlin, Czech Republic
France
Research Site Recruiting
Angers cedex 9, France
Research Site Recruiting
Corbeil-Essonnes, France
Research Site Recruiting
Dijon, France
Research Site Recruiting
Dijon Cedex, France
Research Site Recruiting
La Rochelle, France
Research Site Recruiting
Le Creusot, France
Research Site Recruiting
Nantes Cedex 1, France
Research Site Recruiting
Nantes Cedex 2, France
Research Site Withdrawn
Orleans, France
Research Site Recruiting
Pessac, France
Research Site Recruiting
Poitiers Cedex, France
Research Site Recruiting
TOULOUSE Cedex 9, France
Germany
Research Site Recruiting
Aschaffenburg, Germany
Research Site Recruiting
Bad Lauterberg, Germany
Research Site Recruiting
Bad Mergentheim, Germany
Research Site Recruiting
Bad Oeynhausen, Germany
Research Site Recruiting
Berlin, Germany
Research Site Withdrawn
Berlin, Germany
Research Site Withdrawn
Damme, Germany
Research Site Recruiting
Dippoldiswalde, Germany
Research Site Recruiting
Dresden, Germany
Research Site Withdrawn
Falkensee, Germany
Research Site Recruiting
Freiburg, Germany
Research Site Withdrawn
Hamburg, Germany
Research Site Recruiting
Hamburg, Germany
Research Site Withdrawn
Karlsbad, Germany
Research Site Recruiting
Kassel, Germany
Research Site Recruiting
Köln, Germany
Research Site Recruiting
Leipzig, Germany
Research Site Recruiting
München, Germany
Research Site Withdrawn
Münster, Germany
Research Site Recruiting
Villingen-Schwenningen, Germany
Hong Kong
Research Site Not yet recruiting
Causeway Bay, Hong Kong
Research Site Withdrawn
Hong Kong, Hong Kong
Research Site Not yet recruiting
Hongkong, Hong Kong
Research Site Not yet recruiting
Tai Po, Hong Kong
Hungary
Research Site Recruiting
Acs, Hungary
Research Site Recruiting
Balatonfüred, Hungary
Research Site Recruiting
Ballasagyarmat, Hungary
Research Site Recruiting
Berettyóújfalu, Hungary
Research Site Withdrawn
Budapest, Hungary
Research Site Recruiting
Budapest, Hungary
Research Site Recruiting
Cegléd, Hungary
Research Site Recruiting
Csongrád, Hungary
Research Site Recruiting
Debrecen, Hungary
Research Site Recruiting
Eger, Hungary
Research Site Recruiting
Esztergom, Hungary
Research Site Recruiting
Gyor, Hungary
Research Site Recruiting
Gyöngyös, Hungary
Research Site Recruiting
Kecskemét, Hungary
Research Site Recruiting
Kistarcsa, Hungary
Research Site Recruiting
Komárom, Hungary
Research Site Withdrawn
Miskolc, Hungary
Research Site Recruiting
Morahalom, Hungary
Research Site Recruiting
Nyiregyhaza, Hungary
Research Site Recruiting
Polgar, Hungary
Research Site Recruiting
Sopron, Hungary
Research Site Recruiting
Szolnok, Hungary
Research Site Recruiting
Székesfehérvár, Hungary
Research Site Recruiting
Tát, Hungary
Research Site Recruiting
Zalaegerszeg, Hungary
India
Research Site Not yet recruiting
Ahmedabad, India
Research Site Withdrawn
Bangalore, India
Research Site Not yet recruiting
Bangalore, India
Research Site Withdrawn
Indore, India
Research Site Withdrawn
Jaipur, India
Research Site Not yet recruiting
Jaipur, India
Research Site Not yet recruiting
Kolkatta, India
Research Site Not yet recruiting
Lucknow, India
Research Site Withdrawn
Mumbai, India
Research Site Not yet recruiting
New Delhi, India
Research Site Not yet recruiting
Pune, India
Research Site Not yet recruiting
Vellore, India
Israel
Research Site Recruiting
Afula, Israel
Research Site Recruiting
Ashkelon, Israel
Research Site Recruiting
Beer Sheva, Israel
Research Site Recruiting
Givatayim, Israel
Research Site Recruiting
Hadera, Israel
Research Site Recruiting
Haifa, Israel
Research Site Recruiting
Holon, Israel
Research Site Recruiting
Jerusalem, Israel
Research Site Recruiting
Naharia, Israel
Research Site Recruiting
Petach Tikva, Israel
Italy
Research Site Withdrawn
Ascoli Piceno, Italy
Research Site Recruiting
Bergamo, Italy
Research Site Withdrawn
Catanzaro, Italy
Research Site Recruiting
Firenze, Italy
Research Site Withdrawn
Mercato San Severino, Italy
Research Site Recruiting
Milano, Italy
Research Site Withdrawn
Monza, Italy
Research Site Recruiting
Napoli, Italy
Research Site Recruiting
Negrar - VR, Italy
Research Site Recruiting
Padova, Italy
Research Site Recruiting
Parma, Italy
Research Site Recruiting
Pavia, Italy
Research Site Not yet recruiting
Ravenna, Italy
Research Site Recruiting
Rozzano, Italy
Research Site Recruiting
S Maria Capua Vetere, Italy
Research Site Recruiting
Sessa Aurunca, Italy
Research Site Recruiting
Verona, Italy
Japan
Research Site Recruiting
Bunkyo-ku, Japan
Research Site Recruiting
Daito-shi, Japan
Research Site Recruiting
Kasuga-shi, Japan
Research Site Recruiting
Kobe-shi, Japan
Research Site Recruiting
Kumamoto-shi, Japan
Research Site Recruiting
Matsubara-shi, Japan
Research Site Recruiting
Saga-shi, Japan
Research Site Recruiting
Ube-shi, Japan
Research Site Recruiting
Uji-shi, Japan
Research Site Recruiting
Yao-shi, Japan
Research Site Recruiting
Yokohama-shi, Japan
Korea, Republic of
Research Site Recruiting
Bucheon, Korea, Republic of
Research Site Recruiting
Busan, Korea, Republic of
Research Site Recruiting
Cheongju-si, Korea, Republic of
Research Site Recruiting
Daegu, Korea, Republic of
Research Site Recruiting
Daejeon, Korea, Republic of
Research Site Recruiting
Goyang-si, Korea, Republic of
Research Site Recruiting
Guri, Gyeonggi-do, Korea, Republic of
Research Site Recruiting
Jeonju-si, Jeollabuk-do, Korea, Republic of
Research Site Recruiting
Seongnam-si, Korea, Republic of
Research Site Recruiting
Seoul, Korea, Republic of
Research Site Recruiting
Suwon, Korea, Republic of
Research Site Recruiting
Uijeongbu-si, Korea, Republic of
Mexico
Research Site Recruiting
Acapulco, Mexico
Research Site Recruiting
Culiacan, Mexico
Research Site Recruiting
Del. Cuauhtemoc, Mexico
Research Site Recruiting
Distrito Federal, Mexico
Research Site Withdrawn
Guadalajara, Mexico
Research Site Recruiting
Guadalajara, Mexico
Research Site Recruiting
Meridas, Mexico
Research Site Recruiting
Mexico, Mexico
Research Site Recruiting
Monterey, Mexico
Research Site Recruiting
Monterrey, Mexico
Research Site Recruiting
Pachuca de Soto, Mexico
Research Site Recruiting
Querétaro, Mexico
Research Site Recruiting
San Luis Potosi, Mexico
Research Site Recruiting
Tijuana, Mexico
Research Site Recruiting
Veracruz, Mexico
Research Site Recruiting
Xalapa, Mexico
Research Site Recruiting
Zapopan, Mexico
Research Site Recruiting
Zapopan, Jalisco, Mexico
Netherlands
Research Site Withdrawn
Alkmaar, Netherlands
Research Site Recruiting
Alkmaar, Netherlands
Research Site Withdrawn
Almere, Netherlands
Research Site Recruiting
Amsterdam, Netherlands
Research Site Recruiting
Apeldoorn, Netherlands
Research Site Recruiting
Arnhem, Netherlands
Research Site Recruiting
Breda, Netherlands
Research Site Recruiting
Delft, Netherlands
Research Site Recruiting
Den Haag, Netherlands
Research Site Recruiting
EDE, Netherlands
Research Site Recruiting
Eindhoven, Netherlands
Research Site Recruiting
Gouda, Netherlands
Research Site Recruiting
Groningen, Netherlands
Research Site Recruiting
Hardenberg, Netherlands
Research Site Recruiting
Heerlen, Netherlands
Research Site Recruiting
Hoofddorp, Netherlands
Research Site Recruiting
Hoogeveen, Netherlands
Research Site Recruiting
Nijmegen, Netherlands
Research Site Recruiting
Rotterdam, Netherlands
Research Site Recruiting
Sliedrecht, Netherlands
Research Site Recruiting
Sneek, Netherlands
Research Site Recruiting
Utrecht, Netherlands
Research Site Recruiting
Velp, Netherlands
Research Site Recruiting
Venlo, Netherlands
Research Site Recruiting
Zutphen, Netherlands
Philippines
Research Site Recruiting
Bacolod, Philippines
Research Site Withdrawn
Cebu City, Philippines
Research Site Recruiting
Cebu City, Philippines
Research Site Recruiting
Dasmarinas City, Philippines
Research Site Recruiting
Iloilo City, Philippines
Research Site Recruiting
Lipa City, Philippines
Research Site Recruiting
Makati City, Philippines
Research Site Recruiting
Mandaluyong City, Philippines
Research Site Withdrawn
Manila, Philippines
Research Site Not yet recruiting
Manila, Philippines
Research Site Recruiting
Manila, Philippines
Research Site Recruiting
Marikina City, Philippines
Research Site Recruiting
Pasay City, Philippines
Research Site Recruiting
Pasig City, Philippines
Research Site Recruiting
Quezon City, Philippines
Research Site Recruiting
Tanauan City, Philippines
Poland
Research Site Recruiting
Biała Rawska, Poland
Research Site Recruiting
Bydgoszcz, Poland
Research Site Recruiting
ChrzanÓw, Poland
Research Site Recruiting
Gdansk, Poland
Research Site Recruiting
Gdańsk, Poland
Research Site Recruiting
Gdynia, Poland
Research Site Recruiting
Giżycko, Poland
Research Site Recruiting
Inowrocław, Poland
Research Site Recruiting
Katowice, Poland
Research Site Recruiting
Koluszki, Poland
Research Site Recruiting
Krakow, Poland
Research Site Recruiting
Kraków, Poland
Research Site Recruiting
Legnica, Poland
Research Site Recruiting
Lublin, Poland
Research Site Recruiting
Mrągowo, Poland
Research Site Recruiting
Nakło nad Notecią, Poland
Research Site Recruiting
Poznan, Poland
Research Site Recruiting
Płock, Poland
Research Site Recruiting
Ruda Śląska, Poland
Research Site Recruiting
Skierniewice, Poland
Research Site Recruiting
Sobótka, Poland
Research Site Recruiting
Sokółka, Poland
Research Site Recruiting
Torun, Poland
Research Site Recruiting
Toruń, Poland
Research Site Recruiting
Warszawa, Poland
Research Site Recruiting
Wierzchosławice, Poland
Research Site Recruiting
Wrocław, Poland
Research Site Recruiting
Węgrów, Poland
Research Site Recruiting
Włocławek, Poland
Research Site Recruiting
Zabrze, Poland
Research Site Not yet recruiting
Zamość, Poland
Research Site Recruiting
Łęczna, Poland
Romania
Research Site Recruiting
Bacau, Romania
Research Site Not yet recruiting
Braila, Romania
Research Site Not yet recruiting
Brasov, Romania
Research Site Not yet recruiting
Bucharest, Romania
Research Site Recruiting
Bucharest, Romania
Research Site Recruiting
Bucuresti, Romania
Research Site Not yet recruiting
Bucuresti, Romania
Research Site Recruiting
Cluj Napoca, Romania
Research Site Recruiting
Constanta, Romania
Research Site Recruiting
Galati, Romania
Research Site Recruiting
Iasi, Romania
Research Site Not yet recruiting
Pitesti, Romania
Research Site Recruiting
Ploiesti, Romania
Research Site Recruiting
Sibiu, Romania
Research Site Recruiting
Targu-Mures, Romania
Research Site Recruiting
Timisoara, Romania
Research Site Not yet recruiting
Timisoara, Romania
Research Site Recruiting
Tîrgu Mures, Romania
Research Site Recruiting
Zalau, Romania
Russian Federation
Research Site Recruiting
Arkhangelsk, Russian Federation
Research Site Recruiting
Chelyabinsk, Russian Federation
Research Site Recruiting
Ekaterinburg, Russian Federation
Research Site Withdrawn
Gatchina, Russian Federation
Research Site Recruiting
Ivanovo, Russian Federation
Research Site Recruiting
Izhevsk, Russian Federation
Research Site Not yet recruiting
Izhevsk, Russian Federation
Research Site Recruiting
Kazan, Russian Federation
Research Site Withdrawn
Moscow, Russian Federation
Research Site Not yet recruiting
Moscow, Russian Federation
Research Site Recruiting
Moscow, Russian Federation
Research Site Recruiting
Nizhnii Novgorod, Russian Federation
Research Site Not yet recruiting
Nizhniy Novgorod, Russian Federation
Research Site Recruiting
Novosibirsk, Russian Federation
Research Site Recruiting
Perm, Russian Federation
Research Site Recruiting
Rostov-on-Don, Russian Federation
Research Site Not yet recruiting
Rostov-on-Don, Russian Federation
Research Site Recruiting
Ryazan, Russian Federation
Research Site Withdrawn
Saint Petersburg, Russian Federation
Research Site Recruiting
Saint Petersburg, Russian Federation
Research Site Recruiting
Saint- Petersburg, Russian Federation
Research Site Recruiting
Saint-Petersburg, Russian Federation
Research Site Withdrawn
Saratov, Russian Federation
Research Site Recruiting
Saratov, Russian Federation
Research Site Not yet recruiting
Smolensk, Russian Federation
Research Site Recruiting
Tver, Russian Federation
Research Site Recruiting
Ufa, Russian Federation
Research Site Recruiting
Vladikavkaz, Russian Federation
Research Site Not yet recruiting
Vladimir, Russian Federation
Research Site Recruiting
Volgograd, Russian Federation
Research Site Recruiting
Yekaterinburg, Russian Federation
Slovakia
Research Site Recruiting
Banská Bystrica, Slovakia
Research Site Recruiting
Bratislava, Slovakia
Research Site Recruiting
Dolný Kubín, Slovakia
Research Site Recruiting
Kosice, Slovakia
Research Site Recruiting
Košice, Slovakia
Research Site Recruiting
Levice, Slovakia
Research Site Recruiting
Lučenec, Slovakia
Research Site Recruiting
Nové Zámky, Slovakia
Research Site Recruiting
Námestovo, Slovakia
Research Site Recruiting
Piešťany, Slovakia
Research Site Recruiting
Poprad, Slovakia
Research Site Recruiting
Povazska Bystrica, Slovakia
Research Site Recruiting
Prievidza, Slovakia
Research Site Recruiting
Rimavská Sobota, Slovakia
Research Site Recruiting
Sabinov, Slovakia
Research Site Recruiting
Trebišov, Slovakia
Research Site Recruiting
Trenčín, Slovakia
Research Site Recruiting
Vrútky, Slovakia
Research Site Recruiting
Šaľa, Slovakia
Research Site Recruiting
Žilina, Slovakia
South Africa
Research Site Recruiting
Alberton, South Africa
Research Site Recruiting
Benoni, South Africa
Research Site Recruiting
Cape Town, South Africa
Research Site Recruiting
Diepkloof, Soweto, South Africa
Research Site Recruiting
Durban, South Africa
Research Site Recruiting
Goodwood, South Africa
Research Site Recruiting
Houghton, South Africa
Research Site Recruiting
Johannesburg, South Africa
Research Site Recruiting
Observatory, South Africa
Research Site Recruiting
Parktown, South Africa
Research Site Recruiting
Phoenix, South Africa
Research Site Recruiting
Pretoria, South Africa
Research Site Recruiting
Verulam, South Africa
Research Site Recruiting
Worcester, South Africa
Spain
Research Site Recruiting
Almeria, Spain
Research Site Recruiting
Barcelona, Spain
Research Site Recruiting
L'Hospitalet de Llobregat, Spain
Research Site Recruiting
Madrid, Spain
Research Site Recruiting
Oviedo, Spain
Research Site Recruiting
Sant Joan Despi, Spain
Research Site Recruiting
Santiago de Compostela, Spain
Research Site Withdrawn
Santiago de Compostela, Spain
Research Site Recruiting
Sevilla, Spain
Sweden
Research Site Recruiting
Borås, Sweden
Research Site Recruiting
Eksjö, Sweden
Research Site Recruiting
Finspång, Sweden
Research Site Recruiting
Gothenburg, Sweden
Research Site Recruiting
Jakobsberg, Sweden
Research Site Withdrawn
Jonkoping, Sweden
Research Site Recruiting
Linköping, Sweden
Research Site Recruiting
Lund, Sweden
Research Site Recruiting
Malmo, Sweden
Research Site Recruiting
Ostersund, Sweden
Research Site Recruiting
Rättvik, Sweden
Research Site Recruiting
Stockholm, Sweden
Research Site Withdrawn
Stockholm, Sweden
Research Site Recruiting
Umeå, Sweden
Research Site Withdrawn
Vastervik, Sweden
Research Site Recruiting
Vällingby, Sweden
Research Site Withdrawn
Örebro, Sweden
Taiwan
Research Site Recruiting
Changhua, Taiwan
Research Site Recruiting
Kaohsiung, Taiwan
Research Site Recruiting
Taichung, Taiwan
Research Site Recruiting
Taichung City, Taiwan
Research Site Recruiting
Taipei, Taiwan
Thailand
Research Site Recruiting
Bangkok, Thailand
Research Site Withdrawn
Bangkok, Thailand
Research Site Withdrawn
Bansuan, Muang, Chonburi, Thailand
Research Site Withdrawn
Chaingmai, Thailand
Research Site Recruiting
Chiang Mai, Thailand
Research Site Withdrawn
Hat Yai, Songkla, Thailand
Research Site Recruiting
Muang, Thailand
Research Site Withdrawn
Muang, Nan, Thailand
Research Site Recruiting
Nakhon Ratchasima, Thailand
Research Site Recruiting
Pathumthani, Thailand
Research Site Recruiting
Phisanulok, Thailand
Research Site Recruiting
Rajthevi, Thailand
Research Site Recruiting
Ratchaburi, Thailand
Research Site Recruiting
Ratchathewi, Thailand
Turkey
Research Site Recruiting
Antalya, Turkey
Research Site Recruiting
Istanbul, Turkey
Research Site Recruiting
İzmir, Turkey
Ukraine
Research Site Recruiting
Dnepropetrovsk, Ukraine
Research Site Recruiting
Dnipropetrovsk, Ukraine
Research Site Not yet recruiting
Donetsk, Ukraine
Research Site Recruiting
Donetsk, Ukraine
Research Site Not yet recruiting
Ivano-Frankivsk, Ukraine
Research Site Recruiting
Kharkiv, Ukraine
Research Site Recruiting
Kharkov, Ukraine
Research Site Recruiting
Kiev, Ukraine
Research Site Recruiting
Kyiv, Ukraine
Research Site Withdrawn
Lviv, Ukraine
Research Site Not yet recruiting
Lwiw, Ukraine
Research Site Withdrawn
Mykolaiv, Ukraine
Research Site Recruiting
Vinnytsia, Ukraine
Research Site Recruiting
Vynnitsa, Ukraine
Research Site Recruiting
Zaporizhzhya, Ukraine
Research Site Recruiting
Zaporozhye, Ukraine
United Kingdom
Research Site Recruiting
Addlestone, United Kingdom
Research Site Recruiting
Aylesbury, United Kingdom
Research Site Recruiting
Bath, United Kingdom
Research Site Recruiting
Belfast, United Kingdom
Research Site Recruiting
Blackpool, United Kingdom
Research Site Recruiting
Canterbury, United Kingdom
Research Site Recruiting
Corsham, United Kingdom
Research Site Recruiting
Coventry, United Kingdom
Research Site Recruiting
Glasgow, United Kingdom
Research Site Recruiting
Irvine, United Kingdom
Research Site Recruiting
Leicester, United Kingdom
Research Site Recruiting
Mortimer Reading, United Kingdom
Research Site Recruiting
Sheffield, United Kingdom
Research Site Recruiting
Whitstable, United Kingdom
Vietnam
Research Site Recruiting
Hanoi, Vietnam
Research Site Recruiting
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
The TIMI Study Group
Hadassah Medical Organization
Investigators
Study Director: Eva Johnsson, 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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01730534     History of Changes
Other Study ID Numbers: D1693C00001
Study First Received: November 15, 2012
Last Updated: September 30, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Bulgaria: Ministry of Health
Canada: Health Canada
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
India: Central Drugs Standard Control Organization
Israel: only local ERB for each site
Italy: The Italian Medicines Agency
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Philippines : Food and Drug Administration
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Taiwan : Food and Drug Administration
Thailand: only local ERB for each site
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Ukraine: State Pharmacological Center - Ministry of Health
Vietnam: Ministry of Health

Keywords provided by AstraZeneca:
Phase IIIb
T2DM
cardiovascular events

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

ClinicalTrials.gov processed this record on October 23, 2014