A Study Evaluating Safety and Tolerability of YM150 Compared to Warfarin in Subjects With Atrial Fibrillation (OPAL-2)

January 18, 2011 updated by: Astellas Pharma Inc

A Phase 2, Double-Blind, Double-Dummy, Randomized, Parallel Group Dose Finding Study To Investigate the Safety and Tolerability of YM150 in Subjects With Non-Valvular Atrial Fibrillation and to Compare the Safety and Tolerability With Warfarin

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1280

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Auchenflower, Australia, 4066
      • Caboolture, Australia, 4510
      • Kippa Ring, Australia, 4021
      • Victoria, Australia, 3181
  • Austria
      • Wien, Austria, 1100
      • Wien, Austria, 1160
  • Bulgaria
      • Dimitrovgrad, Bulgaria, 6400
      • Pleven, Bulgaria, 5800
      • Sofia, Bulgaria, 1606
      • Sofia, Bulgaria, 1202
      • Sofia, Bulgaria, 1309
      • Sofia, Bulgaria, 1407
      • Sofia, Bulgaria, 1505
  • Czech Republic
      • Besenov, Czech Republic, 25630
      • Havirov-mesto, Czech Republic, 73601
      • Prague, Czech Republic, 13
      • Tabor, Czech Republic, 2000
      • Usti Nad Labem, Czech Republic, 40113
  • Estonia
      • Narva, Estonia, 20307
      • Tallinn, Estonia, 10617
      • Tallinn, Estonia, 10138
      • Tartu, Estonia, 51014
  • France
      • Paris, France, 75015
  • Germany
      • Bad Nauheim, Germany, 61231
      • Berlin, Germany, 10117
      • Berlin, Germany, 10367
      • Berlin, Germany, 10115
      • Darmstadt, Germany, 64283
      • Dresden, Germany, 1307
      • Hagen, Germany, 58099
      • Kassel, Germany, 34121
      • Mainz, Germany, 55116
      • Mannheim, Germany, 68169
      • Markkleeberg, Germany, 04416
  • Hungary
      • Balatonfured, Hungary, H-8230
      • Budapest, Hungary, H-1134
      • Debrecen, Hungary, H-4030
      • Mosonmagyarovar, Hungary, H-9200
      • Nyiregyhaza, Hungary, H-4400
      • Szekesfehervar, Hungary, H-8000
  • India
      • Ahmedabad, India, 380054
      • Bangalore, India, 560034
      • Bangalore, India, 560052
      • Bangalore, India, 560053
      • Hyderabaad, India, 500036
      • Kolkatta, India, 700054
      • Madurai, India, 625107
      • Nagpur, India, 440012
      • Nashik, India, 42202
      • Nellore, India, 524003
      • Pune, India, 411004
      • Pune, India, 411001
  • Israel
      • Nahariya, Israel, 22100
      • Nazareth, Israel, 16100
      • Rehovot, Israel, 76100
  • Japan
      • Asahikawa, Japan, 078-8214
      • Atsugi, Japan, 243-8550
      • Bunkyo-ku, Japan, 113-8603
      • Daito, Japan, 574-0074
      • Fujisawa, Japan, 251-8550
      • Funabashi, Japan, 274-8503
      • Hachioji, Japan, 193-0098
      • Higashiibaraki-gun, Japan, 311 3193
      • Hiroshima, Japan
      • Kanazawa, Japan, 920 8650
      • Kasaoka, Japan, 714-0043
      • Kishiwada, Japan, 596-8522
      • Kitamoto, Japan, 364-8501
      • Kiyose, Japan, 204 8585
      • Kobe, Japan, 651-1145
      • Meguro-ku, Japan, 153-8515
      • Morioka, Japan, 020-8505
      • Nankoku, Japan, 783-8509
      • Sapporo, Japan, 060-0011
      • Sapporo, Japan, 063 0005
      • Sendai, Japan, 983 8520
      • Shimajiri-gun, Japan, 901-0496
      • Shinjyuku-ku, Japan, 162-8543
      • Shizuoka, Japan, 421-0117
      • Toyama, Japan, 939-8511
      • Wako, Japan, 351 0102
      • Yokohama, Japan, 227-0046
  • Korea, Republic of
      • Busan, Korea, Republic of, 603-175
      • Gwangju, Korea, Republic of, 501-757
      • In Cheon, Korea, Republic of, 405-760
      • Seoul, Korea, Republic of, 137-701
      • Seoul, Korea, Republic of, 158-710
      • Seoul, Korea, Republic of, 138-736
      • Seoul, Korea, Republic of, 120-752
  • Malaysia
      • Kuala Lumpur, Malaysia, 50586
      • Selangor Darul Ehsan, Malaysia, 47500
  • Netherlands
      • AD Delft, Netherlands, 2625
      • AE Roosendaal, Netherlands, 4708
      • BC Amsterdam, Netherlands, 1091
  • Philippines
      • Iloilo, Philippines, 5000
  • Poland
      • Bytom, Poland, 41-902
      • Gdynia, Poland, 81-472
      • Gdynia, Poland, 81-423
      • Katowice, Poland, 40-635
      • Kielce, Poland, 25-735
      • Krakow, Poland, 30-082
      • Lodz, Poland, 91-425
      • Lublin, Poland, 20-954
      • Torun, Poland, 87-100
      • Warsaw, Poland, 02-097
      • Warsaw, Poland, 00-909
      • Warsaw, Poland, 02-057
      • Wroclaw, Poland, 50-981
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
      • Chelyabinsk, Russian Federation, 454021
      • Moscow, Russian Federation, 101990
      • Moscow, Russian Federation, 117485
      • Novosibirsk, Russian Federation, 630117
      • Novosibirsk, Russian Federation, 630008
      • Novosibirsk, Russian Federation, 630012
      • Omsk, Russian Federation, 644046
      • Saratov, Russian Federation, 410028
      • Smolensk, Russian Federation, 214018
      • St Petersburg, Russian Federation, 194156
      • St. Petersburg, Russian Federation, 199106
      • Tomsk, Russian Federation, 643063
      • Tula, Russian Federation, 300035
      • Tyumen, Russian Federation, 625026
  • Slovakia
      • Bardejov, Slovakia, 08501
      • Dolny Kubin, Slovakia, 02601
      • Komarno, Slovakia, 94501
      • Kosice, Slovakia, 04022
      • Liptovsky Hradok, Slovakia, 03301
      • Martin, Slovakia, 03601
  • South Africa
      • Bellville, South Africa, 7530
      • Benoni, South Africa, 1500
      • Centurion, South Africa, 0157
      • Chatsworth, South Africa, 4092
      • Moreletta Park, South Africa, 0044
      • Somerset West, South Africa, 7130
      • Tongaat, South Africa, 4400
      • Umhlanga, South Africa, 4320
      • Worcester, South Africa, 6850
  • Spain
      • Murcia, Spain, 30008
      • Sevilla, Spain, 41009
      • Viladecans, Spain, 08840
  • Thailand
      • Bangkok, Thailand, 10330
      • Chiang Mai, Thailand, 50200
  • Ukraine
      • Cherkassy, Ukraine, 18009
      • Donetsk, Ukraine, 83114
      • Ivano Frankivsk, Ukraine, 76075
      • Kharkiv, Ukraine, 61002
      • Kharkiv, Ukraine, 61039
      • Kharkiv, Ukraine, 61037
      • Kharkiv, Ukraine, 61178
      • Kharkiv, Ukraine, 61018
      • Kyiv, Ukraine, 02660
      • Kyiv, Ukraine, 03680
      • Kyiv, Ukraine, 02038
      • Kyiv, Ukraine, 3680
      • Kyiv, Ukraine, 4050
      • Lutsk, Ukraine, 43024
      • Lviv, Ukraine, 79013
      • Odessa, Ukraine, 65059
      • Ternopil, Ukraine, 46002
      • Vinnytsya, Ukraine, 21005
      • Zaporizhzhya, Ukraine, 69118
  • United Kingdom
      • Addlestone, United Kingdom, KT 15 2BH
      • Bath, United Kingdom, BA2 3HT
      • Birmingham, United Kingdom, B18 7QH
      • Dundee, United Kingdom, DD1 9SY
      • East Horsley, United Kingdom, KT24 6QT
      • London, United Kingdom, SE5 8AF
      • Soham, United Kingdom, CB7 5JD
      • Southampton, United Kingdom, SO16 6YD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1. YM150, Dose W, twice daily
Drug: YM150
oral
Experimental: 2. YM150, Dose X, once daily
Drug: YM150
oral
Experimental: 3. YM150, Dose X, twice daily
Drug: YM150
oral
Experimental: 4. YM150, Dose Y once daily
Drug: YM150
oral
Experimental: 5. YM150, Dose Y twice daily
Drug: YM150
oral
Experimental: 6. YM150, Dose Z, once daily
Drug: YM150
oral
Active Comparator: 7. Warfarin
Drug: Warfarin
oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of major and clinically relevant non-major bleeding events
Time Frame: Double-blind treatment period (variable, up to 16 months)
Double-blind treatment period (variable, up to 16 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Composite and individual incidences of ischemic strokes, TIAs, systemic thrombolic events, ACS, all deaths
Time Frame: Double-blind treatment period (variable, up to 16 months)
Double-blind treatment period (variable, up to 16 months)
Incidence of bleeding events
Time Frame: Double-blind treatment period (variable, up to 16 months)
Double-blind treatment period (variable, up to 16 months)
Assessment of other safety variables
Time Frame: Double blind treatment period (variable, up to 16 months)
Double blind treatment period (variable, up to 16 months)
Assessment of PK/PD variables
Time Frame: Double-blind treatment period (up to week 12)
Double-blind treatment period (up to week 12)
Patient Reported Outcomes
Time Frame: Double-blind treatment period (up to week 24)
Double-blind treatment period (up to week 24)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

July 1, 2009

First Submitted That Met QC Criteria

July 13, 2009

First Posted (Estimate)

July 14, 2009

Study Record Updates

Last Update Posted (Estimate)

January 20, 2011

Last Update Submitted That Met QC Criteria

January 18, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 150-CL-021
  • 2007-001150-87 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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