Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01609582




Registration number
NCT01609582
Ethics application status
Date submitted
29/05/2012
Date registered
1/06/2012
Date last updated
19/10/2015

Titles & IDs
Public title
Study of TAK-875 in Adults With Type 2 Diabetes and Cardiovascular Disease or Risk Factors for Cardiovascular Disease
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate Cardiovascular Outcomes of TAK-875, 50 mg in Addition to Standard of Care in Subjects With Type 2 Diabetes and With Cardiovascular Disease or Multiple Risk Factors for Cardiovascular Events
Secondary ID [1] 0 0
2011-001732-37
Secondary ID [2] 0 0
TAK-875_306
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Cardiovascular Disease 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TAK-875
Treatment: Drugs - TAK-875 Placebo

Experimental: TAK-875 50 mg - TAK-875 50 mg tablets, orally, once daily for up to 6 years.

Placebo Comparator: Placebo - TAK-875 placebo-matching tablets, orally, once daily for up to 6 years.


Treatment: Drugs: TAK-875
TAK-875 tablets

Treatment: Drugs: TAK-875 Placebo
TAK-875 placebo-matching tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to First Occurrence of Any Component of Primary Major Adverse Cardiovascular Event (MACE) Composite
Timepoint [1] 0 0
Baseline up to end of study (up to Day 588)
Secondary outcome [1] 0 0
Time to First Occurrence of Any Component of Secondary Major Adverse Cardiovascular Event (MACE) Composite
Timepoint [1] 0 0
Baseline up to end of study (up to Day 588)

Eligibility
Key inclusion criteria
1. In the opinion of the investigator, the patient is capable of understanding and
complying with protocol requirements, including scheduled clinic appointments.

2. The patient or, when applicable, the patient's legally acceptable representative signs
and dates a written, informed consent form and any required privacy authorization
prior to the initiation of any study procedures.

3. Has a diagnosis of type 2 diabetes mellitus.

4. Has an glycosylated hemoglobin (HbA1c) level between 7.0% and 10.5%, inclusive, at
Screening. HbA1c testing may be repeated once during Screening.

5. Meets at least one (1) of the following three (3) High Risk Categories (a-c ):

1. A documented history of myocardial infarction (MI) occurring no less than 2
months (60 days) and no greater than 24 months prior to Screening.

2. Documented symptomatic peripheral arterial disease (PAD) (at least one (1) of the
following three (3) criteria must be satisfied): i) Current intermittent
claudication together with documented ankle-brachial index =0.85. ii) History of
previous vascular intervention for intermittent claudication or resting limb
ischemia (example: amputation for arterial disease, peripheral bypass, or history
of angioplasty/stenting). iii) History of symptomatic carotid artery disease
(requiring revascularization with carotid endarterectomy (CEA) or stenting).

3. Documented cerebrovascular disease (at least one (1) of the following two (2)
criteria must be satisfied): i) A history of transient ischemic attack (TIA)
confirmed by a neurologist no greater than 24 months prior to screening and
clinically and neurologically stable at randomization. ii) A history of ischemic
stroke (IS) (with a Modified Rankin Scale Score =3 documented prior to
Randomization) not less than 2 months (60 days) and no greater than 24 months
prior to Screening, and clinically and neurologically stable at Randomization.
The Modified Rankin Scale is located in appendix in protocol.

Or meets at least one (1) of the following five (5) Intermediate Risk Categories
(d-h):

4. Stable angina with coronary disease documented by the presence of inducible
ischemia or scar by stress myocardial perfusion imaging (MPI), echocardiogram or
magnetic resonance imaging (MRI) in the past 24 months.

5. Multi vessel coronary disease, based on coronary angiography, with or without
angina, documented by >50% diameter stenosis in at least 2 of the 3 major
coronary distributions.

6. A history of percutaneous coronary intervention (PCI) or coronary artery bypass
grafting (CABG) at least 2 months prior to Screening.

7. The subject has diabetic nephropathy plus (2) of the clinical criteria listed
below (i. to vi.). Diabetic nephropathy is defined as either urinary albumin
excretion = 30 µg/mg creatinine (3.4 mg/mmol creatinine) (based on a random spot
collection) or urinary albumin excretion = 30 mg/24h (based on a 24 h or timed
collection). Results must be confirmed on at least two specimens collected within
12 months prior to Screening and no more than 6 months apart: i)Duration of
diabetes = 10 years on pharmacological treatment documented within medical
records. ii) Confirmed systolic blood pressure (SBP) =150 mm Hg on 2 separate
days during Screening despite treatment with at least 2 anti-hypertensive
medications administered at doses considered optimal by local standard of care.
iii) Presence of dyslipidemia as defined by any one (1) of the following
confirmed at screening: A. Low density lipoprotein (LDL) > 100 mg/dl (2.59
mmol/L) while on statin therapy administered at maximum tolerated dose or optimal
dose based on local standard of care for at least 4 weeks prior to screening. B.
LDL > 130 mg/dL (3.37 mmol/L) when not on statin therapy. C. High density
lipoprotein (HDL) < 40 mg/dL (1.04 mmol/L) in males or < 45 mg/dL (1.17 mmol/L)
in females. D. Fasting Triglyceride >200 mg/dL(2.26 mmol/L). iv) Currently
smoking >10 cigarettes per day at Screening. v) Male =65 years of age or female
=70 years of age. vi) Highly selective C-reactive protein (hs-CRP) > 2.0 mg/L in
the absence of intercurrent infection or acute process.

h.) The subject meets at least five (5) of the following clinical criteria: i.)
Duration of diabetes =10 years on pharmacological treatment documented within medical
records. ii) Confirmed systolic blood pressure (SBP) =150 mm Hg on 2 separate days
during Screening despite treatment with at least 2 anti-hypertensive medications
administered at doses considered optimal by local standard of care. iii) Presence of
dyslipidemia as defined by any one (1) of the following confirmed at screening: A. Low
density lipoprotein (LDL) > 100 mg/dl (2.59 mmol/L) while on statin therapy
administered at maximum tolerated dose or optimal dose based on local standard of care
for at least 4 weeks prior to screening. B. LDL > 130 mg/dL (3.37 mmol/L) when not on
statin therapy. C. High density lipoprotein (HDL) < 40 mg/dL (1.04 mmol/L) in males or
< 45 mg/dL (1.17 mmol/L) in females. D. Fasting Triglyceride >200 mg/dL(2.26 mmol/L).
iv) Currently smoking >10 cigarettes per day at Screening. v) Male =65 years of age or
female =70 years of age. vi) Highly selective C-reactive protein (hs-CRP) > 2.0 mg/L
in the absence of intercurrent infection or acute process.

6. Is able and willing to monitor glucose with a home glucose monitor and consistently
record his or her own blood glucose concentrations in patient diaries.

7. A female of childbearing potential who is sexually active with a non-sterilized male
partner agrees to routinely use adequate contraception from signing of informed
consent throughout the duration of the study and for 30 days after the last dose of
study drug.

8. Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =3x
upper limit of normal (ULN) and if ALT or AST elevated above ULN, have chronic,
well-compensated liver disease documented by usual clinical parameters.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Has received any investigational medication within 30 days prior to Screening or any
investigational antidiabetic medication or excluded medications within 3 months prior
to Screening.

2. Has been randomized into a previous TAK-875 study.

3. Is an immediate family member, study site employee, or is in a dependant relationship
with a study site employee who is involved in conduct of this study (eg, spouse,
parent, biological or legally adopted child, or sibling) or may consent under duress

4. Is diagnosed with type 1 diabetes mellitus or latent autoimmune diabetes in adults.

5. Is hemodynamically unstable, including severe heart failure (New York Heart
Association Class IV) at Screening.

6. Is hospitalized at the Screening Visit for the event associated with the CV inclusion
criteria. (Patients who have been discharged from an acute hospital to a cardiac
rehabilitation center or nursing home at the time of the Screening Visit or
Randomization Visit are not excluded).

7. Has ALT and/or AST levels >3.0x ULN at Screening.

8. Has a total bilirubin level >ULN at Screening. Exception: if a patient has documented
Gilbert's Syndrome, the patient will be allowed with an elevated bilirubin level per
the investigator's discretion.

9. Has an glomerular filtration rate (estimated) (eGFR) = 15 mL/min/1.73m2 based on
Modification of Diet in Renal Disease (MDRD) calculation at Screening and is currently
on dialysis or expected to start dialysis within the next 6 months.

10. Has uncontrolled thyroid disease, as determined by the investigator and/or clinical
investigation.

11. Has a known history of infection with human immunodeficiency virus (HIV).

12. Has a known active infection with Hepatitis B virus (HBV), or Hepatitis C virus (HCV)
requiring antiviral treatment.

13. Has a history of drug abuse (defined as illicit drug use) or a history of alcohol
abuse within 2 years prior to Screening.

14. Has any major illness or condition that, in the investigator's opinion, prohibits the
patient from participating in the study or meeting the planned visit schedule.

15. Has a history of hypersensitivity, allergies, or has had an anaphylactic reaction(s)
to TAK-875.

16. If female, is pregnant (confirmed by laboratory testing, ie, serum or urine human
chorionic gonadotropin (hCG), in females of childbearing potential) or lactating or
intending to become pregnant before, during, or within 30 days after participating in
this study; or intending to donate ova during such time period.

17. Is unable to understand verbal or written English or any other language for which a
certified translation of the approved informed consent is available.

18. Has a history of cancer that has been in remission for <5 years prior to Screening. A
history of basal cell carcinoma or Stage 1 squamous cell carcinoma of the skin is
allowed.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2014
Sample size
Target
Accrual to date
Final
3207
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
- Bruce
Recruitment hospital [2] 0 0
- Canberra
Recruitment hospital [3] 0 0
- Garran
Recruitment hospital [4] 0 0
- Westmead
Recruitment hospital [5] 0 0
- Wollongong
Recruitment hospital [6] 0 0
- Brisbane
Recruitment hospital [7] 0 0
- Meadowbrook
Recruitment hospital [8] 0 0
- Milton
Recruitment hospital [9] 0 0
- Townsville
Recruitment hospital [10] 0 0
- Woolloongabba
Recruitment hospital [11] 0 0
- Adelaide
Recruitment hospital [12] 0 0
- Daw Park
Recruitment hospital [13] 0 0
- Elizabeth Vale
Recruitment hospital [14] 0 0
- Clayton
Recruitment hospital [15] 0 0
- Fitzroy
Recruitment hospital [16] 0 0
- Geelong
Recruitment hospital [17] 0 0
- Melbourne
Recruitment hospital [18] 0 0
- Sale
Recruitment hospital [19] 0 0
- Joondalup
Recruitment postcode(s) [1] 0 0
- Bruce
Recruitment postcode(s) [2] 0 0
- Canberra
Recruitment postcode(s) [3] 0 0
- Garran
Recruitment postcode(s) [4] 0 0
- Westmead
Recruitment postcode(s) [5] 0 0
- Wollongong
Recruitment postcode(s) [6] 0 0
- Brisbane
Recruitment postcode(s) [7] 0 0
- Meadowbrook
Recruitment postcode(s) [8] 0 0
- Milton
Recruitment postcode(s) [9] 0 0
- Townsville
Recruitment postcode(s) [10] 0 0
- Woolloongabba
Recruitment postcode(s) [11] 0 0
- Adelaide
Recruitment postcode(s) [12] 0 0
- Daw Park
Recruitment postcode(s) [13] 0 0
- Elizabeth Vale
Recruitment postcode(s) [14] 0 0
- Clayton
Recruitment postcode(s) [15] 0 0
- Fitzroy
Recruitment postcode(s) [16] 0 0
- Geelong
Recruitment postcode(s) [17] 0 0
- Melbourne
Recruitment postcode(s) [18] 0 0
- Sale
Recruitment postcode(s) [19] 0 0
- Joondalup
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Delaware
Country [8] 0 0
United States of America
State/province [8] 0 0
District of Columbia
Country [9] 0 0
United States of America
State/province [9] 0 0
Florida
Country [10] 0 0
United States of America
State/province [10] 0 0
Georgia
Country [11] 0 0
United States of America
State/province [11] 0 0
Illinois
Country [12] 0 0
United States of America
State/province [12] 0 0
Indiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Iowa
Country [14] 0 0
United States of America
State/province [14] 0 0
Kansas
Country [15] 0 0
United States of America
State/province [15] 0 0
Kentucky
Country [16] 0 0
United States of America
State/province [16] 0 0
Louisiana
Country [17] 0 0
United States of America
State/province [17] 0 0
Maine
Country [18] 0 0
United States of America
State/province [18] 0 0
Maryland
Country [19] 0 0
United States of America
State/province [19] 0 0
Massachusetts
Country [20] 0 0
United States of America
State/province [20] 0 0
Michigan
Country [21] 0 0
United States of America
State/province [21] 0 0
Minnesota
Country [22] 0 0
United States of America
State/province [22] 0 0
Missouri
Country [23] 0 0
United States of America
State/province [23] 0 0
Nebraska
Country [24] 0 0
United States of America
State/province [24] 0 0
Nevada
Country [25] 0 0
United States of America
State/province [25] 0 0
New Hampshire
Country [26] 0 0
United States of America
State/province [26] 0 0
New Jersey
Country [27] 0 0
United States of America
State/province [27] 0 0
New Mexico
Country [28] 0 0
United States of America
State/province [28] 0 0
New York
Country [29] 0 0
United States of America
State/province [29] 0 0
North Carolina
Country [30] 0 0
United States of America
State/province [30] 0 0
Ohio
Country [31] 0 0
United States of America
State/province [31] 0 0
Oklahoma
Country [32] 0 0
United States of America
State/province [32] 0 0
Oregon
Country [33] 0 0
United States of America
State/province [33] 0 0
Pennsylvania
Country [34] 0 0
United States of America
State/province [34] 0 0
Rhode Island
Country [35] 0 0
United States of America
State/province [35] 0 0
South Carolina
Country [36] 0 0
United States of America
State/province [36] 0 0
Tennessee
Country [37] 0 0
United States of America
State/province [37] 0 0
Texas
Country [38] 0 0
United States of America
State/province [38] 0 0
Utah
Country [39] 0 0
United States of America
State/province [39] 0 0
Virginia
Country [40] 0 0
United States of America
State/province [40] 0 0
Washington
Country [41] 0 0
United States of America
State/province [41] 0 0
West Virginia
Country [42] 0 0
United States of America
State/province [42] 0 0
Wisconsin
Country [43] 0 0
Argentina
State/province [43] 0 0
Buenos Aires
Country [44] 0 0
Argentina
State/province [44] 0 0
Chubut
Country [45] 0 0
Argentina
State/province [45] 0 0
Ciudad Autonoma Buenos Aires
Country [46] 0 0
Argentina
State/province [46] 0 0
Cordoba
Country [47] 0 0
Argentina
State/province [47] 0 0
Jujy
Country [48] 0 0
Argentina
State/province [48] 0 0
Mendoza
Country [49] 0 0
Argentina
State/province [49] 0 0
Rio Negro
Country [50] 0 0
Argentina
State/province [50] 0 0
Santa Fe
Country [51] 0 0
Argentina
State/province [51] 0 0
Tucuman
Country [52] 0 0
Argentina
State/province [52] 0 0
Corrientes
Country [53] 0 0
Argentina
State/province [53] 0 0
Rosario
Country [54] 0 0
Argentina
State/province [54] 0 0
Salta
Country [55] 0 0
Argentina
State/province [55] 0 0
Santiago del estero
Country [56] 0 0
Brazil
State/province [56] 0 0
Ceará
Country [57] 0 0
Brazil
State/province [57] 0 0
Distrito Federal
Country [58] 0 0
Brazil
State/province [58] 0 0
Goiás
Country [59] 0 0
Brazil
State/province [59] 0 0
Paraná
Country [60] 0 0
Brazil
State/province [60] 0 0
Pará
Country [61] 0 0
Brazil
State/province [61] 0 0
Pernambuco
Country [62] 0 0
Brazil
State/province [62] 0 0
Rio Grande do Sul
Country [63] 0 0
Brazil
State/province [63] 0 0
Sao Paulo
Country [64] 0 0
Bulgaria
State/province [64] 0 0
Blagoevgrad
Country [65] 0 0
Bulgaria
State/province [65] 0 0
Byala
Country [66] 0 0
Bulgaria
State/province [66] 0 0
Kazanlak
Country [67] 0 0
Bulgaria
State/province [67] 0 0
Pazardzhik
Country [68] 0 0
Bulgaria
State/province [68] 0 0
Plovdiv
Country [69] 0 0
Bulgaria
State/province [69] 0 0
Sevlievo
Country [70] 0 0
Bulgaria
State/province [70] 0 0
Sofia
Country [71] 0 0
Bulgaria
State/province [71] 0 0
Stara Zagora
Country [72] 0 0
Bulgaria
State/province [72] 0 0
Varna
Country [73] 0 0
Canada
State/province [73] 0 0
Alberta
Country [74] 0 0
Canada
State/province [74] 0 0
British Columbia
Country [75] 0 0
Canada
State/province [75] 0 0
Manitoba
Country [76] 0 0
Canada
State/province [76] 0 0
Ontario
Country [77] 0 0
Canada
State/province [77] 0 0
Quebec
Country [78] 0 0
Croatia
State/province [78] 0 0
Cakovec
Country [79] 0 0
Croatia
State/province [79] 0 0
Karlovac
Country [80] 0 0
Croatia
State/province [80] 0 0
Koprivnica
Country [81] 0 0
Croatia
State/province [81] 0 0
Krapinske Toplice
Country [82] 0 0
Croatia
State/province [82] 0 0
Osijek
Country [83] 0 0
Croatia
State/province [83] 0 0
Rijeka
Country [84] 0 0
Croatia
State/province [84] 0 0
Sisak
Country [85] 0 0
Croatia
State/province [85] 0 0
Slavonski Brod
Country [86] 0 0
Croatia
State/province [86] 0 0
Split
Country [87] 0 0
Croatia
State/province [87] 0 0
Virovitica
Country [88] 0 0
Croatia
State/province [88] 0 0
Zadar
Country [89] 0 0
Croatia
State/province [89] 0 0
Zagreb
Country [90] 0 0
Czech Republic
State/province [90] 0 0
Ceske Budejovice
Country [91] 0 0
Czech Republic
State/province [91] 0 0
Chocen
Country [92] 0 0
Czech Republic
State/province [92] 0 0
Jindrichuv Hradec
Country [93] 0 0
Czech Republic
State/province [93] 0 0
Kromeriz
Country [94] 0 0
Czech Republic
State/province [94] 0 0
Marianske Lazne
Country [95] 0 0
Czech Republic
State/province [95] 0 0
Moravsky Krumlov
Country [96] 0 0
Czech Republic
State/province [96] 0 0
Olomouc
Country [97] 0 0
Czech Republic
State/province [97] 0 0
Ostrava - Moravska Ostrava
Country [98] 0 0
Czech Republic
State/province [98] 0 0
Ostrava - Vitkovice
Country [99] 0 0
Czech Republic
State/province [99] 0 0
Ostrava
Country [100] 0 0
Czech Republic
State/province [100] 0 0
Prague 10
Country [101] 0 0
Czech Republic
State/province [101] 0 0
Praha 4 - Krc
Country [102] 0 0
Czech Republic
State/province [102] 0 0
Praha 5
Country [103] 0 0
Czech Republic
State/province [103] 0 0
Slany
Country [104] 0 0
Czech Republic
State/province [104] 0 0
Trutnov
Country [105] 0 0
Czech Republic
State/province [105] 0 0
Usti nad Labem
Country [106] 0 0
Estonia
State/province [106] 0 0
Paide
Country [107] 0 0
Estonia
State/province [107] 0 0
Tallinn
Country [108] 0 0
Estonia
State/province [108] 0 0
Tartu
Country [109] 0 0
France
State/province [109] 0 0
Essonne
Country [110] 0 0
France
State/province [110] 0 0
Gironde
Country [111] 0 0
France
State/province [111] 0 0
Hauts de Seine
Country [112] 0 0
France
State/province [112] 0 0
Loire Atlantique
Country [113] 0 0
France
State/province [113] 0 0
Rhone
Country [114] 0 0
France
State/province [114] 0 0
Paris
Country [115] 0 0
Germany
State/province [115] 0 0
Baden Wuerttemberg
Country [116] 0 0
Germany
State/province [116] 0 0
Brandenburg
Country [117] 0 0
Germany
State/province [117] 0 0
Hessen
Country [118] 0 0
Germany
State/province [118] 0 0
Nordrhein Westfalen
Country [119] 0 0
Germany
State/province [119] 0 0
Rheinland Pfalz
Country [120] 0 0
Germany
State/province [120] 0 0
Sachsen Anhalt
Country [121] 0 0
Germany
State/province [121] 0 0
Sachsen
Country [122] 0 0
Germany
State/province [122] 0 0
Berlin
Country [123] 0 0
Germany
State/province [123] 0 0
Hamburg
Country [124] 0 0
Hong Kong
State/province [124] 0 0
Hong Kong
Country [125] 0 0
Hong Kong
State/province [125] 0 0
New Territories
Country [126] 0 0
Hungary
State/province [126] 0 0
Baja
Country [127] 0 0
Hungary
State/province [127] 0 0
Balatonfured
Country [128] 0 0
Hungary
State/province [128] 0 0
Budaors
Country [129] 0 0
Hungary
State/province [129] 0 0
Budapest
Country [130] 0 0
Hungary
State/province [130] 0 0
Debrecen
Country [131] 0 0
Hungary
State/province [131] 0 0
Eger
Country [132] 0 0
Hungary
State/province [132] 0 0
Godollo
Country [133] 0 0
Hungary
State/province [133] 0 0
Gyula
Country [134] 0 0
Hungary
State/province [134] 0 0
Kecskemet
Country [135] 0 0
Hungary
State/province [135] 0 0
Kistelek
Country [136] 0 0
Hungary
State/province [136] 0 0
Komarom
Country [137] 0 0
Hungary
State/province [137] 0 0
Mako
Country [138] 0 0
Hungary
State/province [138] 0 0
Pecs
Country [139] 0 0
Hungary
State/province [139] 0 0
Szeged
Country [140] 0 0
Hungary
State/province [140] 0 0
Szekszard
Country [141] 0 0
Hungary
State/province [141] 0 0
Szikszo
Country [142] 0 0
Hungary
State/province [142] 0 0
Szombathely
Country [143] 0 0
Hungary
State/province [143] 0 0
Urhida
Country [144] 0 0
Hungary
State/province [144] 0 0
Veszprem
Country [145] 0 0
Hungary
State/province [145] 0 0
Zalaegerszeg
Country [146] 0 0
Israel
State/province [146] 0 0
Ashkelon
Country [147] 0 0
Israel
State/province [147] 0 0
Beer Sheva
Country [148] 0 0
Israel
State/province [148] 0 0
Beer Yaakov
Country [149] 0 0
Israel
State/province [149] 0 0
Beer-Sheva
Country [150] 0 0
Israel
State/province [150] 0 0
Givataim
Country [151] 0 0
Israel
State/province [151] 0 0
Hadera
Country [152] 0 0
Israel
State/province [152] 0 0
Haifa
Country [153] 0 0
Israel
State/province [153] 0 0
Holon
Country [154] 0 0
Israel
State/province [154] 0 0
Jerusalem
Country [155] 0 0
Israel
State/province [155] 0 0
Kfar-Saba
Country [156] 0 0
Israel
State/province [156] 0 0
Petach Tikva
Country [157] 0 0
Israel
State/province [157] 0 0
Petach Tikwa
Country [158] 0 0
Israel
State/province [158] 0 0
Raanana
Country [159] 0 0
Israel
State/province [159] 0 0
Tel Aviv
Country [160] 0 0
Israel
State/province [160] 0 0
Zefat
Country [161] 0 0
Italy
State/province [161] 0 0
Milano
Country [162] 0 0
Italy
State/province [162] 0 0
Firenze
Country [163] 0 0
Italy
State/province [163] 0 0
Pavia
Country [164] 0 0
Korea, Republic of
State/province [164] 0 0
Gangwon-do
Country [165] 0 0
Korea, Republic of
State/province [165] 0 0
Gyeonggi-do
Country [166] 0 0
Korea, Republic of
State/province [166] 0 0
Gyeongsangnam-do
Country [167] 0 0
Korea, Republic of
State/province [167] 0 0
Jeollabuk-do
Country [168] 0 0
Korea, Republic of
State/province [168] 0 0
Busan
Country [169] 0 0
Korea, Republic of
State/province [169] 0 0
Gyeonggi
Country [170] 0 0
Korea, Republic of
State/province [170] 0 0
Seoul
Country [171] 0 0
Latvia
State/province [171] 0 0
Daugavpils
Country [172] 0 0
Latvia
State/province [172] 0 0
Jelgava
Country [173] 0 0
Latvia
State/province [173] 0 0
Limbazi
Country [174] 0 0
Latvia
State/province [174] 0 0
Ogre
Country [175] 0 0
Latvia
State/province [175] 0 0
Riga
Country [176] 0 0
Latvia
State/province [176] 0 0
Talsi
Country [177] 0 0
Latvia
State/province [177] 0 0
Valmiera
Country [178] 0 0
Lithuania
State/province [178] 0 0
Alytus
Country [179] 0 0
Lithuania
State/province [179] 0 0
Kaunas
Country [180] 0 0
Lithuania
State/province [180] 0 0
Klaipeda
Country [181] 0 0
Malaysia
State/province [181] 0 0
Johor
Country [182] 0 0
Malaysia
State/province [182] 0 0
Kedah
Country [183] 0 0
Malaysia
State/province [183] 0 0
Kelantan
Country [184] 0 0
Malaysia
State/province [184] 0 0
Kuala Lumpur
Country [185] 0 0
Malaysia
State/province [185] 0 0
Perak
Country [186] 0 0
Malaysia
State/province [186] 0 0
Selangor
Country [187] 0 0
Malaysia
State/province [187] 0 0
Melaka
Country [188] 0 0
Malaysia
State/province [188] 0 0
Terengganu
Country [189] 0 0
Mexico
State/province [189] 0 0
Baja California Norte
Country [190] 0 0
Mexico
State/province [190] 0 0
Coahuila
Country [191] 0 0
Mexico
State/province [191] 0 0
Distrito Federal
Country [192] 0 0
Mexico
State/province [192] 0 0
Estado de Mexico
Country [193] 0 0
Mexico
State/province [193] 0 0
Guerrero
Country [194] 0 0
Mexico
State/province [194] 0 0
Hidalgo
Country [195] 0 0
Mexico
State/province [195] 0 0
Jalisco
Country [196] 0 0
Mexico
State/province [196] 0 0
Michoacán
Country [197] 0 0
Mexico
State/province [197] 0 0
Morelos
Country [198] 0 0
Mexico
State/province [198] 0 0
Nuevo Le=n
Country [199] 0 0
Mexico
State/province [199] 0 0
Nuevo Leon
Country [200] 0 0
Mexico
State/province [200] 0 0
Nuevo León
Country [201] 0 0
Mexico
State/province [201] 0 0
San Luis Potos
Country [202] 0 0
Mexico
State/province [202] 0 0
Sinaloa
Country [203] 0 0
Mexico
State/province [203] 0 0
Veracruz
Country [204] 0 0
Mexico
State/province [204] 0 0
Yucatán
Country [205] 0 0
Mexico
State/province [205] 0 0
Aguascalientes
Country [206] 0 0
Mexico
State/province [206] 0 0
Chihuahua
Country [207] 0 0
Mexico
State/province [207] 0 0
Durango
Country [208] 0 0
Mexico
State/province [208] 0 0
Tamaulipas
Country [209] 0 0
New Zealand
State/province [209] 0 0
Auckland
Country [210] 0 0
New Zealand
State/province [210] 0 0
Christchurch
Country [211] 0 0
New Zealand
State/province [211] 0 0
Dunedin
Country [212] 0 0
New Zealand
State/province [212] 0 0
Palmerston North
Country [213] 0 0
New Zealand
State/province [213] 0 0
Tauranga
Country [214] 0 0
New Zealand
State/province [214] 0 0
Wellington
Country [215] 0 0
Peru
State/province [215] 0 0
Callao
Country [216] 0 0
Peru
State/province [216] 0 0
Cusco
Country [217] 0 0
Peru
State/province [217] 0 0
Huacho
Country [218] 0 0
Peru
State/province [218] 0 0
Ica
Country [219] 0 0
Peru
State/province [219] 0 0
La Libertad
Country [220] 0 0
Peru
State/province [220] 0 0
Lima
Country [221] 0 0
Peru
State/province [221] 0 0
Piura
Country [222] 0 0
Philippines
State/province [222] 0 0
Baguio City
Country [223] 0 0
Philippines
State/province [223] 0 0
Cebu City
Country [224] 0 0
Philippines
State/province [224] 0 0
Dasmariñas City, Cavite
Country [225] 0 0
Philippines
State/province [225] 0 0
Davao City
Country [226] 0 0
Philippines
State/province [226] 0 0
Iloilo City
Country [227] 0 0
Philippines
State/province [227] 0 0
Marikina City
Country [228] 0 0
Philippines
State/province [228] 0 0
Quezon City
Country [229] 0 0
Philippines
State/province [229] 0 0
Tarlac
Country [230] 0 0
Philippines
State/province [230] 0 0
Taytay
Country [231] 0 0
Poland
State/province [231] 0 0
Bialystok
Country [232] 0 0
Poland
State/province [232] 0 0
Gdansk
Country [233] 0 0
Poland
State/province [233] 0 0
Gliwice
Country [234] 0 0
Poland
State/province [234] 0 0
Grodzisk Mazowiecki
Country [235] 0 0
Poland
State/province [235] 0 0
Kamieniec Zabkowicki
Country [236] 0 0
Poland
State/province [236] 0 0
Leczyca
Country [237] 0 0
Poland
State/province [237] 0 0
Lodz
Country [238] 0 0
Poland
State/province [238] 0 0
Lublin
Country [239] 0 0
Poland
State/province [239] 0 0
Oswiecim
Country [240] 0 0
Poland
State/province [240] 0 0
Parczew
Country [241] 0 0
Poland
State/province [241] 0 0
Poznan
Country [242] 0 0
Poland
State/province [242] 0 0
Pulawy
Country [243] 0 0
Poland
State/province [243] 0 0
Radom
Country [244] 0 0
Poland
State/province [244] 0 0
Ruda Slaska
Country [245] 0 0
Poland
State/province [245] 0 0
Rzeszow
Country [246] 0 0
Poland
State/province [246] 0 0
Warszawa
Country [247] 0 0
Poland
State/province [247] 0 0
Wroclaw
Country [248] 0 0
Romania
State/province [248] 0 0
Bacau
Country [249] 0 0
Romania
State/province [249] 0 0
Baia Mare
Country [250] 0 0
Romania
State/province [250] 0 0
Brasov
Country [251] 0 0
Romania
State/province [251] 0 0
Bucuresti
Country [252] 0 0
Romania
State/province [252] 0 0
Galati
Country [253] 0 0
Romania
State/province [253] 0 0
Iasi
Country [254] 0 0
Romania
State/province [254] 0 0
Oradea
Country [255] 0 0
Romania
State/province [255] 0 0
Ploiesti
Country [256] 0 0
Romania
State/province [256] 0 0
Targu Mures
Country [257] 0 0
Romania
State/province [257] 0 0
Timisoara
Country [258] 0 0
Russian Federation
State/province [258] 0 0
Arkhangelsk
Country [259] 0 0
Russian Federation
State/province [259] 0 0
Barnaul
Country [260] 0 0
Russian Federation
State/province [260] 0 0
Kazan
Country [261] 0 0
Russian Federation
State/province [261] 0 0
Kemerovo
Country [262] 0 0
Russian Federation
State/province [262] 0 0
Moscow
Country [263] 0 0
Russian Federation
State/province [263] 0 0
Nizhniy Novgorod
Country [264] 0 0
Russian Federation
State/province [264] 0 0
Novosibirsk
Country [265] 0 0
Russian Federation
State/province [265] 0 0
Pushkin
Country [266] 0 0
Russian Federation
State/province [266] 0 0
Saratov
Country [267] 0 0
Russian Federation
State/province [267] 0 0
St. Petersburg
Country [268] 0 0
Russian Federation
State/province [268] 0 0
Yaroslavl
Country [269] 0 0
Slovakia
State/province [269] 0 0
Bratislava
Country [270] 0 0
Slovakia
State/province [270] 0 0
Komarno
Country [271] 0 0
Slovakia
State/province [271] 0 0
Kosice
Country [272] 0 0
Slovakia
State/province [272] 0 0
Levice
Country [273] 0 0
Slovakia
State/province [273] 0 0
Lucenec
Country [274] 0 0
Slovakia
State/province [274] 0 0
Martin
Country [275] 0 0
Slovakia
State/province [275] 0 0
Nitra
Country [276] 0 0
Slovakia
State/province [276] 0 0
Nove Mesto nad Vahom
Country [277] 0 0
Slovakia
State/province [277] 0 0
Presov
Country [278] 0 0
Slovakia
State/province [278] 0 0
Sahy
Country [279] 0 0
Slovakia
State/province [279] 0 0
Svidnik
Country [280] 0 0
Slovakia
State/province [280] 0 0
Trencin
Country [281] 0 0
Slovakia
State/province [281] 0 0
Zilina
Country [282] 0 0
South Africa
State/province [282] 0 0
Eastern Cape
Country [283] 0 0
South Africa
State/province [283] 0 0
Free State
Country [284] 0 0
South Africa
State/province [284] 0 0
Gauteng
Country [285] 0 0
South Africa
State/province [285] 0 0
KwaZulu-Natal
Country [286] 0 0
South Africa
State/province [286] 0 0
Western Cape
Country [287] 0 0
Taiwan
State/province [287] 0 0
Douliou City
Country [288] 0 0
Taiwan
State/province [288] 0 0
Kaohsiung
Country [289] 0 0
Taiwan
State/province [289] 0 0
New Taipei City
Country [290] 0 0
Taiwan
State/province [290] 0 0
Taichung
Country [291] 0 0
Taiwan
State/province [291] 0 0
Tainan
Country [292] 0 0
Taiwan
State/province [292] 0 0
Taipei
Country [293] 0 0
Thailand
State/province [293] 0 0
Bangkok
Country [294] 0 0
Thailand
State/province [294] 0 0
Chiang Mai
Country [295] 0 0
Thailand
State/province [295] 0 0
Chiang Rai
Country [296] 0 0
Thailand
State/province [296] 0 0
Khon Kaen
Country [297] 0 0
Thailand
State/province [297] 0 0
Nakhon Ratchasima
Country [298] 0 0
Ukraine
State/province [298] 0 0
Donetsk
Country [299] 0 0
Ukraine
State/province [299] 0 0
Kharkiv
Country [300] 0 0
Ukraine
State/province [300] 0 0
Kyiv
Country [301] 0 0
Ukraine
State/province [301] 0 0
Lugansk
Country [302] 0 0
Ukraine
State/province [302] 0 0
Mykolayiv
Country [303] 0 0
Ukraine
State/province [303] 0 0
Odesa
Country [304] 0 0
Ukraine
State/province [304] 0 0
Poltava
Country [305] 0 0
Ukraine
State/province [305] 0 0
Simferopol
Country [306] 0 0
Ukraine
State/province [306] 0 0
Ternopil
Country [307] 0 0
Ukraine
State/province [307] 0 0
Vinnycia
Country [308] 0 0
Ukraine
State/province [308] 0 0
Vinnytsia
Country [309] 0 0
Ukraine
State/province [309] 0 0
Zaporizhzhia
Country [310] 0 0
United Kingdom
State/province [310] 0 0
Cornwall
Country [311] 0 0
United Kingdom
State/province [311] 0 0
Devon
Country [312] 0 0
United Kingdom
State/province [312] 0 0
East Riding of Yorkshire
Country [313] 0 0
United Kingdom
State/province [313] 0 0
East Sussex
Country [314] 0 0
United Kingdom
State/province [314] 0 0
Hampshire
Country [315] 0 0
United Kingdom
State/province [315] 0 0
Hertfordshire
Country [316] 0 0
United Kingdom
State/province [316] 0 0
Kent
Country [317] 0 0
United Kingdom
State/province [317] 0 0
Lancashire
Country [318] 0 0
United Kingdom
State/province [318] 0 0
Leicestershire
Country [319] 0 0
United Kingdom
State/province [319] 0 0
Merseyside
Country [320] 0 0
United Kingdom
State/province [320] 0 0
Middlesex
Country [321] 0 0
United Kingdom
State/province [321] 0 0
Staffordshire
Country [322] 0 0
United Kingdom
State/province [322] 0 0
West Glamorgan
Country [323] 0 0
United Kingdom
State/province [323] 0 0
Cardiff

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Takeda
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to demonstrate no excess risk of cardiovascular (CV) composite
events exists following long term treatment with TAK-875 compared with placebo.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01609582
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sr. Medical Director Clinical Science
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01609582