A Study Evaluating Safety and Tolerability of YM150 Compared to Warfarin in Subjects With Atrial Fibrillation

NCT00938730 | Completed Phase 2 DMC

• 2 other identifiers: 150-CL-0212007-001150-87
• Study Type: interventional
• Target: 1,280
• Locations: 21 countries
• Sites: 165

Brief Summary

The purpose of this study is to investigate the optimal daily dose and dose regimen of YM150 in subjects with non-valvular atrial fibrillation (NVAF), primarily based on safety and tolerability data.

Conditions

Atrial Fibrillation

Keywords

Nonvalvular Atrial Fibrillation (NVAF); Factor Xa Inhibitor; Stroke; Thromboembolism; Transient Ischemic attack; Anticoagulants; Prevention; YM150; Warfarin

Outcome Measures

Primary Outcomes (1)

• Incidence of major and clinically relevant non-major bleeding events

  Double-blind treatment period (variable, up to 16 months)

Secondary Outcomes (5)

• Composite and individual incidences of ischemic strokes, TIAs, systemic thrombolic events, ACS, all deaths

  Double-blind treatment period (variable, up to 16 months)

• Incidence of bleeding events

  Double-blind treatment period (variable, up to 16 months)

• Assessment of other safety variables

  Double blind treatment period (variable, up to 16 months)

• Assessment of PK/PD variables

  Double-blind treatment period (up to week 12)

• Patient Reported Outcomes

  Double-blind treatment period (up to week 24)

Study Arms (7)

1. YM150, Dose W, twice daily

EXPERIMENTAL

Drug: YM150

2. YM150, Dose X, once daily

EXPERIMENTAL

Drug: YM150

3. YM150, Dose X, twice daily

EXPERIMENTAL

Drug: YM150

4. YM150, Dose Y once daily

EXPERIMENTAL

Drug: YM150

5. YM150, Dose Y twice daily

EXPERIMENTAL

Drug: YM150

6. YM150, Dose Z, once daily

EXPERIMENTAL

Drug: YM150

7. Warfarin

ACTIVE COMPARATOR

Drug: Warfarin

Interventions

YM150 DRUG

oral

1. YM150, Dose W, twice daily; 2. YM150, Dose X, once daily; 3. YM150, Dose X, twice daily; 4. YM150, Dose Y once daily; 5. YM150, Dose Y twice daily; 6. YM150, Dose Z, once daily

Warfarin DRUG

oral

7. Warfarin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject with paroxysmal, permanent or persistent Nonvalvular Atrial Fibrillation (NVAF)
• Subject has prothrombin time international normalized ratio (INR) of 2.0 or below at the baseline visit

You may not qualify if:

• Subject has current or recent (within 12 months prior to screening) history of stroke and/or systemic embolism (including TIA)
• Subject has active bleeding or any condition associated with increased risk of bleeding
• Subject has NVAF secondary to other reversible disorders (e.g. thyrotoxicosis)
• Subject has an indication for warfarin other than AF (including planned cardioversion)
• Subject has had a diagnosis of Acute Coronary Syndrome (ACS), coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within previous 3 months of screening
• Subject has a diagnosis of left ventricular aneurysm or atrial myxoma
• Subject requires use of prohibited previous and concomitant medication (i.e., thrombolytics \[such as tissue Plasminogen Activator (tPA), streptokinase\], antiplatelet agents \[such as cilostazol, clopidogrel, ticlopidine, dipyridamole\], anticoagulants \[such as vitamin K antagonists, heparin, unfractionated or low molecular weight heparin, fondaparinux, thrombin inhibitors\] and chronic use of nonsteroidal anti-inflammatory drugs \[NSAIDs\] or acetylsalicylic acid use of \>100 mg/day). (see Section 5.1.3 and Appendix 1 for details)
• Subject has active infective endocarditis
• Subject is planned for invasive procedures with potential for bleeding
• Subject 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
• Subject has participated in any YM150 clinical trials

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (170)

Unknown Facility

Auchenflower, 4066, Australia

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Caboolture, 4510, Australia

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Kippa-Ring, 4021, Australia

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Victoria, 3181, Australia

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Vienna, 1100, Austria

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Vienna, 1160, Austria

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Dimitrovgrad, 6400, Bulgaria

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Pleven, 5800, Bulgaria

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Sofia, 1202, Bulgaria

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Sofia, 1309, Bulgaria

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Sofia, 1407, Bulgaria

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Sofia, 1505, Bulgaria

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Sofia, 1606, Bulgaria

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Besenov, 25630, Czechia

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Havirov-mesto, 73601, Czechia

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Prague, 13, Czechia

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Tábor, 2000, Czechia

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Ústí nad Labem, 40113, Czechia

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Narva, 20307, Estonia

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Tallinn, 10138, Estonia

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Tallinn, 10617, Estonia

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Tartu, 51014, Estonia

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Paris, 75015, France

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Bad Nauheim, 61231, Germany

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Berlin, 10115, Germany

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Berlin, 10117, Germany

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Berlin, 10367, Germany

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Darmstadt, 64283, Germany

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Dresden, 1307, Germany

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Hagen, 58099, Germany

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Kassel, 34121, Germany

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Mainz, 55116, Germany

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Mannheim, 68169, Germany

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Markkleeberg, 04416, Germany

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Balatonfüred, H-8230, Hungary

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Budapest, H-1134, Hungary

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Debrecen, H-4030, Hungary

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Mosonmagyaróvár, H-9200, Hungary

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Nyíregyháza, H-4400, Hungary

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Székesfehérvár, H-8000, Hungary

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Ahmedabad, 380054, India

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Bangalore, 560034, India

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Bangalore, 560052, India

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Bangalore, 560053, India

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Hyderabaad, 500036, India

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Kolkata, 700054, India

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Madurai, 625107, India

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Nagpur, 440012, India

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Nashik, 42202, India

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Nellore, 524003, India

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Pune, 411001, India

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Pune, 411004, India

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Nahariya, 22100, Israel

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Nazareth, 16100, Israel

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Rehovot, 76100, Israel

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Asahikawa, 078-8214, Japan

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Atsugi, 243-8550, Japan

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Bunkyō City, 113-8603, Japan

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Daitō, 574-0074, Japan

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Fujisawa, 251-8550, Japan

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Funabashi, 274-8503, Japan

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Hachiōji, 193-0098, Japan

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Higashiibaraki-gun, 311 3193, Japan

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Hiroshima, Japan

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Kanazawa, 920 8650, Japan

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Kasaoka, 714-0043, Japan

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Kishiwada, 596-8522, Japan

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Kitamoto, 364-8501, Japan

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Kiyose, 204 8585, Japan

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Kobe, 651-1145, Japan

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Meguro-ku, 153-8515, Japan

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Morioka, 020-8505, Japan

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Nankoku, 783-8509, Japan

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Sapporo, 060-0011, Japan

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Sapporo, 063 0005, Japan

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Sendai, 983 8520, Japan

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Shimajiri-gun, 901-0496, Japan

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Shinjyuku-ku, 162-8543, Japan

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Shizuoka, 421-0117, Japan

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Toyama, 939-8511, Japan

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Wako, 351 0102, Japan

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Yokohama, 227-0046, Japan

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Kuala Lumpur, 50586, Malaysia

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Selangor Darul Ehsan, 47500, Malaysia

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AD Delft, 2625, Netherlands

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AE Roosendaal, 4708, Netherlands

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BC Amsterdam, 1091, Netherlands

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Iloilo City, 5000, Philippines

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Bytom, 41-902, Poland

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Gdynia, 81-423, Poland

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Gdynia, 81-472, Poland

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Katowice, 40-635, Poland

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Kielce, 25-735, Poland

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Krakow, 30-082, Poland

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Lodz, 91-425, Poland

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Lublin, 20-954, Poland

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Torun, 87-100, Poland

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Warsaw, 00-909, Poland

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Warsaw, 02-057, Poland

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Warsaw, 02-097, Poland

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Wroclaw, 50-981, Poland

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Arkhangelsk, 163045, Russia

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Chelyabinsk, 454021, Russia

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Moscow, 101990, Russia

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Moscow, 117485, Russia

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Novosibirsk, 630008, Russia

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Novosibirsk, 630012, Russia

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Novosibirsk, 630117, Russia

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Omsk, 644046, Russia

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Saint Petersburg, 194156, Russia

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Saint Petersburg, 199106, Russia

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Saratov, 410028, Russia

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Smolensk, 214018, Russia

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Tomsk, 643063, Russia

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Tula, 300035, Russia

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Tyumen, 625026, Russia

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Bardejov, 08501, Slovakia

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Dolný Kubín, 02601, Slovakia

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Komárno, 94501, Slovakia

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Košice, 04022, Slovakia

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Liptovský Hrádok, 03301, Slovakia

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Martin, 03601, Slovakia

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Bellville, 7530, South Africa

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Benoni, 1500, South Africa

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Centurion, 0157, South Africa

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Chatsworth, 4092, South Africa

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Moreletapark, 0044, South Africa

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Somerset West, 7130, South Africa

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Tongaat, 4400, South Africa

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Umhlanga, 4320, South Africa

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Worcester, 6850, South Africa

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Busan, 603-175, South Korea

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Gwangju, 501-757, South Korea

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Incheon, 405-760, South Korea

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Seoul, 120-752, South Korea

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Seoul, 137-701, South Korea

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Seoul, 138-736, South Korea

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Seoul, 158-710, South Korea

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Murcia, 30008, Spain

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Seville, 41009, Spain

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Viladecans, 08840, Spain

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Bangkok, 10330, Thailand

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Chiang Mai, 50200, Thailand

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Cherkassy, 18009, Ukraine

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Donetsk, 83114, Ukraine

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Ivano-Frankivsk, 76075, Ukraine

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Kharkiv, 61002, Ukraine

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Kharkiv, 61018, Ukraine

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Kharkiv, 61037, Ukraine

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Kharkiv, 61039, Ukraine

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Kharkiv, 61178, Ukraine

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Kyiv, 02038, Ukraine

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Kyiv, 02660, Ukraine

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Kyiv, 03680, Ukraine

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Kyiv, 3680, Ukraine

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Kyiv, 4050, Ukraine

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Lutsk, 43024, Ukraine

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Lviv, 79013, Ukraine

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Odesa, 65059, Ukraine

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Ternopil, 46002, Ukraine

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Vinnytsia, 21005, Ukraine

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Zaporizhzhya, 69118, Ukraine

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Addlestone, KT 15 2BH, United Kingdom

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Bath, BA2 3HT, United Kingdom

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Birmingham, B18 7QH, United Kingdom

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Dundee, DD1 9SY, United Kingdom

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East Horsley, KT24 6QT, United Kingdom

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London, SE5 8AF, United Kingdom

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Soham, CB7 5JD, United Kingdom

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Southampton, SO16 6YD, United Kingdom

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MeSH Terms

Conditions

Atrial Fibrillation; Stroke; Thromboembolism; Ischemic Attack, Transient

Interventions

Warfarin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Embolism and Thrombosis; Brain Ischemia

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Use Central Contact

  Astellas Pharma Europe B.V.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 1, 2009
• First Posted: July 14, 2009
• Study Start: June 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: January 20, 2011

Record last verified: 2011-01

Locations

ES (4); TH (2); UA (19); NL (3); AU (4); FR (1); DE (11); ZA (9); IN (12); GB (8); KR (7); IL (3); JP (27); HU (6); BU (7); CZ (5); PH (1); PL (13); MY (2); RU (15); SL (6)