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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00699998




Registration number
NCT00699998
Ethics application status
Date submitted
16/06/2008
Date registered
18/06/2008
Date last updated
7/05/2013

Titles & IDs
Public title
A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects
Scientific title
A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects With Unstable Angina/Non-ST-Elevation Myocardial Infarction Who Are Medically Managed
Secondary ID [1] 0 0
H7T-MC-TABY(b)
Secondary ID [2] 0 0
11058
Universal Trial Number (UTN)
Trial acronym
TRILOGY ACS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Clopidogrel
Treatment: Drugs - Prasugrel
Treatment: Drugs - Commercially-available Aspirin

Experimental: Prasugrel - Prasugrel and Low-dose Commercially-available Aspirin

Active comparator: Clopidogrel - Clopidogrel and Low-Dose Commercially-available Aspirin


Treatment: Drugs: Clopidogrel
300 milligrams (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study

Treatment: Drugs: Prasugrel
30 milligrams (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight and age), oral, once daily as maintenance dose through end of study

Treatment: Drugs: Commercially-available Aspirin
Low-dose aspirin, oral, as prescribed by physician through end of study

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke
Timepoint [1] 0 0
Randomization through end of study (30-month visit)
Secondary outcome [1] 0 0
Percentage of Participants With a Composite Endpoint of CV Death and MI
Timepoint [1] 0 0
Randomization through end of study (30-month visit)
Secondary outcome [2] 0 0
Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA)
Timepoint [2] 0 0
Randomization through end of study (30-month visit)
Secondary outcome [3] 0 0
Percentage of Participants With a Composite Endpoint of All-cause Death, MI, or Stroke
Timepoint [3] 0 0
Randomization through end of study (30-month visit)
Secondary outcome [4] 0 0
Platelet Aggregation Measures
Timepoint [4] 0 0
Day 30 and 12 Months
Secondary outcome [5] 0 0
Biomarker Measurements of Inflammation/Hemodynamic Stress: Brain Natriuretic Peptide (BNP)
Timepoint [5] 0 0
Day 30 and 6 Months
Secondary outcome [6] 0 0
Biomarker Measurements of Inflammation/Hemodynamic Stress: C-Reactive Protein (CRP)
Timepoint [6] 0 0
Day 30 and Month 6
Secondary outcome [7] 0 0
Genotyping Related to Drug Metabolism
Timepoint [7] 0 0
Baseline
Secondary outcome [8] 0 0
Economic and Quality of Life Outcomes
Timepoint [8] 0 0
Baseline and follow-up (24 months)
Secondary outcome [9] 0 0
Summary of All Deaths
Timepoint [9] 0 0
Randomization through end of study (30-month visit)

Eligibility
Key inclusion criteria
Key

* Have had a Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) index event within 10 days prior to randomization
* Had a medical management strategy decision made with reasonable certainty that neither percutaneous coronary intervention (PCI) nor coronary artery bypass graft (CABG) is planned for treatment of the index event
* Had at least 1 of 4 specified high-risk features at the time of the UA/NSTEMI event

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Decision for medical management greater than 72 hours after onset of index event without commercial clopidogrel treatment within 72 hours following onset of the index event.
* Insignificant coronary artery disease (CAD) on coronary angiography if performed for Index Event (absence of greater than or equal to 30% stenosis in at least one native vessel)
* Previous or planned PCI or CABG as treatment for the index event
* PCI/CABG within previous 30 days
* ST-segment elevation myocardial infarction (STEMI) as the index event
* Cardiogenic shock, Refractory ventricular arrhythmias, New York Heart Association (NYHA) Class IV congestive heart failure (CHF) within the previous 24 hours
* History of ischemic or hemorrhagic stroke, transient ischemic attack (TIA), Intracranial neoplasm, arteriovenous malformation, or aneurysm
* History of spontaneous gastrointestinal (GI) or non-GI bleeding requiring hospitalization for treatment, unless definitive treatment has occurred and there is low likelihood of recurrence
* Hemodialysis or peritoneal dialysis

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Coffs Harbour
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Lismore
Recruitment hospital [3] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Newcastle
Recruitment hospital [4] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Wollongong
Recruitment hospital [5] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Herston
Recruitment hospital [6] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Nambour
Recruitment hospital [7] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Redcliffe
Recruitment hospital [8] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Southport
Recruitment hospital [9] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Bedford Park
Recruitment hospital [10] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Elizabeth Vale
Recruitment hospital [11] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Hobart
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2480 - Lismore
Recruitment postcode(s) [3] 0 0
2305 - Newcastle
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
4560 - Nambour
Recruitment postcode(s) [7] 0 0
4020 - Redcliffe
Recruitment postcode(s) [8] 0 0
4215 - Southport
Recruitment postcode(s) [9] 0 0
5042 - Bedford Park
Recruitment postcode(s) [10] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [11] 0 0
7000 - Hobart
Recruitment outside Australia
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France
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France
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France
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France
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France
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Germany
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Germany
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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India
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Ahmedabad
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India
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Anand
Country [222] 0 0
India
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India
State/province [223] 0 0
Bangalore
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India
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Baramati
Country [225] 0 0
India
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Bikaner
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India
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Calicut
Country [227] 0 0
India
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Chidambaram
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India
State/province [228] 0 0
Cochin
Country [229] 0 0
India
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Coimbatore
Country [230] 0 0
India
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Ernakulam
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India
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Guntur
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India
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Gurgaon
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India
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Hyderabaad
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India
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Indore
Country [235] 0 0
India
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India
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Jalandhar
Country [237] 0 0
India
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Kolkata
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India
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Country [239] 0 0
India
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Lucknow
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India
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Madurai
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India
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Mumbai
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India
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India
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India
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Nashik
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India
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India
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India
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Pune
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India
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Saket
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India
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Secunderabad
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India
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India
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Solapur
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India
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Surat
Country [253] 0 0
India
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Thrissur
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India
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Tirupati
Country [255] 0 0
India
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Country [256] 0 0
India
State/province [256] 0 0
Vadodara
Country [257] 0 0
India
State/province [257] 0 0
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Country [258] 0 0
India
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Visakhapatnam
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Dublin
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Ireland
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Galway
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Israel
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Israel
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Ashkelon
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Israel
State/province [263] 0 0
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Country [264] 0 0
Israel
State/province [264] 0 0
Eilat
Country [265] 0 0
Israel
State/province [265] 0 0
Haifa
Country [266] 0 0
Israel
State/province [266] 0 0
Jerusalem
Country [267] 0 0
Israel
State/province [267] 0 0
Kfar Saba
Country [268] 0 0
Israel
State/province [268] 0 0
Nahariya
Country [269] 0 0
Israel
State/province [269] 0 0
Nazareth
Country [270] 0 0
Israel
State/province [270] 0 0
Rehovot
Country [271] 0 0
Israel
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Tel Aviv
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Israel
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Tel Hashomer
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Israel
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Israel
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Tzfat
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Albano Laziale
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Italy
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Ascoli Piceno
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Bari
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Italy
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Italy
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Mexico
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Philippines
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Philippines
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Philippines
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Philippines
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Philippines
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Philippines
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Targoviste
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Kemerovo
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Rostov-On-Don
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Russian Federation
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Saint Petersburg
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Russian Federation
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Country [429] 0 0
Russian Federation
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Russian Federation
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Serbia
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Nis
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Serbia
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Slovakia
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Spain
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Spain
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Spain
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Spain
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Spain
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Spain
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Spain
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Spain
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Sweden
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Sweden
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Karlstad
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Sweden
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Switzerland
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Winterthur
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Taiwan
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Country [468] 0 0
Taiwan
State/province [468] 0 0
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Country [469] 0 0
Thailand
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Country [470] 0 0
Thailand
State/province [470] 0 0
Chiang Mai
Country [471] 0 0
Thailand
State/province [471] 0 0
Khon Kaen
Country [472] 0 0
Thailand
State/province [472] 0 0
Nakhon Ratchasima
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Thailand
State/province [473] 0 0
Pathumthani
Country [474] 0 0
Thailand
State/province [474] 0 0
Udon Thani
Country [475] 0 0
Tunisia
State/province [475] 0 0
La Marsa
Country [476] 0 0
Tunisia
State/province [476] 0 0
Menzel Bourguiba
Country [477] 0 0
Tunisia
State/province [477] 0 0
Monastir
Country [478] 0 0
Tunisia
State/province [478] 0 0
Sfax
Country [479] 0 0
Tunisia
State/province [479] 0 0
Sousse
Country [480] 0 0
Tunisia
State/province [480] 0 0
Tunis Monfleury
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Tunisia
State/province [481] 0 0
Tunis
Country [482] 0 0
Turkey
State/province [482] 0 0
Adana
Country [483] 0 0
Turkey
State/province [483] 0 0
Ankara
Country [484] 0 0
Turkey
State/province [484] 0 0
Bolu
Country [485] 0 0
Turkey
State/province [485] 0 0
Bursa
Country [486] 0 0
Turkey
State/province [486] 0 0
Edirne
Country [487] 0 0
Turkey
State/province [487] 0 0
Erzurum
Country [488] 0 0
Turkey
State/province [488] 0 0
Isparta
Country [489] 0 0
Turkey
State/province [489] 0 0
Istanbul
Country [490] 0 0
Turkey
State/province [490] 0 0
Kocaeli
Country [491] 0 0
Turkey
State/province [491] 0 0
Konya
Country [492] 0 0
Turkey
State/province [492] 0 0
Kirikkale
Country [493] 0 0
Turkey
State/province [493] 0 0
Samsun
Country [494] 0 0
Turkey
State/province [494] 0 0
Trabzon
Country [495] 0 0
Ukraine
State/province [495] 0 0
Cherkasy
Country [496] 0 0
Ukraine
State/province [496] 0 0
Dnipropetrovsk
Country [497] 0 0
Ukraine
State/province [497] 0 0
Donetsk
Country [498] 0 0
Ukraine
State/province [498] 0 0
Ivano-Frankivsk
Country [499] 0 0
Ukraine
State/province [499] 0 0
Kharkiv
Country [500] 0 0
Ukraine
State/province [500] 0 0
Kiev
Country [501] 0 0
Ukraine
State/province [501] 0 0
Kryvyy Rig
Country [502] 0 0
Ukraine
State/province [502] 0 0
Kyiv
Country [503] 0 0
Ukraine
State/province [503] 0 0
Lugansk
Country [504] 0 0
Ukraine
State/province [504] 0 0
Lutsk
Country [505] 0 0
Ukraine
State/province [505] 0 0
Lviv
Country [506] 0 0
Ukraine
State/province [506] 0 0
Mykolayiv
Country [507] 0 0
Ukraine
State/province [507] 0 0
Odesa
Country [508] 0 0
Ukraine
State/province [508] 0 0
Poltava
Country [509] 0 0
Ukraine
State/province [509] 0 0
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Country [510] 0 0
Ukraine
State/province [510] 0 0
Vinnytsya
Country [511] 0 0
Ukraine
State/province [511] 0 0
Zaporozhye
Country [512] 0 0
United Kingdom
State/province [512] 0 0
Cleveland
Country [513] 0 0
United Kingdom
State/province [513] 0 0
Cnwll
Country [514] 0 0
United Kingdom
State/province [514] 0 0
County Durham
Country [515] 0 0
United Kingdom
State/province [515] 0 0
Derbyshire
Country [516] 0 0
United Kingdom
State/province [516] 0 0
Devon
Country [517] 0 0
United Kingdom
State/province [517] 0 0
East Sussex
Country [518] 0 0
United Kingdom
State/province [518] 0 0
East Yorkshire
Country [519] 0 0
United Kingdom
State/province [519] 0 0
Essex
Country [520] 0 0
United Kingdom
State/province [520] 0 0
Greater London
Country [521] 0 0
United Kingdom
State/province [521] 0 0
Gwent
Country [522] 0 0
United Kingdom
State/province [522] 0 0
Hampshire
Country [523] 0 0
United Kingdom
State/province [523] 0 0
Kent
Country [524] 0 0
United Kingdom
State/province [524] 0 0
Lincolnshire
Country [525] 0 0
United Kingdom
State/province [525] 0 0
Merseyside
Country [526] 0 0
United Kingdom
State/province [526] 0 0
North Yorkshire
Country [527] 0 0
United Kingdom
State/province [527] 0 0
Nottinghamshire
Country [528] 0 0
United Kingdom
State/province [528] 0 0
Somerset
Country [529] 0 0
United Kingdom
State/province [529] 0 0
Tays
Country [530] 0 0
United Kingdom
State/province [530] 0 0
Warwickshire
Country [531] 0 0
United Kingdom
State/province [531] 0 0
West Lothian
Country [532] 0 0
United Kingdom
State/province [532] 0 0
West Midlands
Country [533] 0 0
United Kingdom
State/province [533] 0 0
West Yorkshire
Country [534] 0 0
United Kingdom
State/province [534] 0 0
Northampton
Country [535] 0 0
United Kingdom
State/province [535] 0 0
Sunderland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Daiichi Sankyo Co., Ltd.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Duke Clinical Research Institute
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.