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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1280

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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