Study Evaluating Safety, Tolerability and Efficacy of YM150 in Subjects With Acute Coronary Syndromes
NCT ID: NCT00994292
Last Updated: 2015-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
1276 participants
INTERVENTIONAL
2009-09-30
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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1. YM150 Dose V, twice daily
YM150
oral
2. YM150 Dose W, once daily
YM150
oral
3. YM150 Dose X, twice daily
YM150
oral
4. YM150 Dose Y, once daily
YM150
oral
5. YM150 Dose Y, twice daily
YM150
oral
6. YM150 Dose Z, once daily
YM150
oral
7. Placebo
Placebo
oral
Interventions
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YM150
oral
Placebo
oral
Eligibility Criteria
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Inclusion Criteria
* has elevated cardiac biomarkers
Exclusion Criteria
* has had recent stroke or TIA ≤ 12 months prior to index event
* has persistent BP of 160 mmHg systolic or higher and/or 100 mmHg diastolic or higher at baseline with or without medication
* has participated in another clinical trial of an investigational drug (including placebo) or device within 30 days (or the limit set by national law, whichever is longer) of signing informed consent for the present study
* has participated in any YM150 clinical trials
* requires ongoing parenteral or oral anticoagulant therapy
* has active bleeding or is in the opinion of the investigator at high risk of bleeding during the study
18 Years
ALL
No
Sponsors
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Astellas Pharma Europe B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma Europe B.V.
Locations
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Gyeonggi-do, , South Korea
Inchon, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kyiv, , Ukraine
Zaporizhzhya, , Ukraine
Western Cape, , South Africa
Worcester, , South Africa
Busan, , South Korea
Buenos Aires, , Argentina
Corrientes, , Argentina
Salta, , Argentina
Salta, , Argentina
Concord, , Australia
Douglas, , Australia
Aalst, , Belgium
Bonheiden, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Genk, , Belgium
Leper, , Belgium
Ottignies, , Belgium
Brasília, , Brazil
Porto Alegre, , Brazil
Recife, , Brazil
Salvador, , Brazil
São José, , Brazil
São Paulo, , Brazil
Uberlândia, , Brazil
Cambridge, , Canada
Hamilton, , Canada
Laval, , Canada
Longueuil, , Canada
Montreal, , Canada
Montreal, , Canada
Montreal, , Canada
Saint-Jérôme, , Canada
Barranquilla, , Colombia
Bogotá, , Colombia
Cartagena, , Colombia
Floridablanca, , Colombia
Beroun, , Czechia
Brno, , Czechia
Brno, , Czechia
Jihlava, , Czechia
Kladno, , Czechia
Liberec, , Czechia
Pardubice, , Czechia
Prague, , Czechia
Sternberk, , Czechia
Vsetín, , Czechia
Zlín, , Czechia
Copenhagen, , Denmark
Paris, , France
Bad Nauheim, , Germany
Dresden, , Germany
Freiburg im Breisgau, , Germany
Kassel, , Germany
Neuss, , Germany
Balatonfüred, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Miskolc, , Hungary
Nyíregyháza, , Hungary
Szeged, , Hungary
Gwangju, , South Korea
Székesfehérvár, , Hungary
Zalaegerszeg, , Hungary
Ahmedabad, , India
Ahmedabad, , India
Ahmedabad, , India
Hyderabaad, , India
Hyderabaad, , India
Mangalore, , India
Nagpur, , India
New Delhi, , India
Tamil Nadu, , India
Tirupati, , India
Burócratas del Estado, , Mexico
Guadalajara, , Mexico
Guadalajara, , Mexico
Mérida, , Mexico
Morelia, , Mexico
Zapopan, , Mexico
's-Hertogenbosch, , Netherlands
Amsterdam, , Netherlands
Heerlen, , Netherlands
Helmond, , Netherlands
Leeuwarden, , Netherlands
Nijmegen, , Netherlands
Oss, , Netherlands
Bialystok, , Poland
Elblag, , Poland
Gdansk, , Poland
Inowrocław, , Poland
Krakow, , Poland
Przemyśl, , Poland
Baia Mare, , Romania
Brăila, , Romania
Bucharest, , Romania
Bucharest, , Romania
Craiova, , Romania
Oradea, , Romania
Târgovişte, , Romania
Târgu Mureş, , Romania
Chelyabinsk, , Russia
Kemerovo, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Saratov, , Russia
Tomsk, , Russia
Tyumen, , Russia
Tyumen, , Russia
Yaroslavl, , Russia
Martin, , Slovakia
Nitra, , Slovakia
Rimavská Sobota, , Slovakia
Ružomberok, , Slovakia
George, , South Africa
Johannesburg, , South Africa
Kuilsriver, , South Africa
Parow, , South Africa
Pinelands, , South Africa
Tongaat, , South Africa
Umhlanga, , South Africa
Countries
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References
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Steg PG, Mehta SR, Jukema JW, Lip GY, Gibson CM, Kovar F, Kala P, Garcia-Hernandez A, Renfurm RW, Granger CB; RUBY-1 Investigators. RUBY-1: a randomized, double-blind, placebo-controlled trial of the safety and tolerability of the novel oral factor Xa inhibitor darexaban (YM150) following acute coronary syndrome. Eur Heart J. 2011 Oct;32(20):2541-54. doi: 10.1093/eurheartj/ehr334. Epub 2011 Aug 30.
Other Identifiers
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2008-005972-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
150-CL-201
Identifier Type: -
Identifier Source: org_study_id
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