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Arthroplasty, Replacement, KneePhase 2PEARLNCT00595426

A Study to Evaluate the Safety and Efficacy of YM150 in Patients With Knee Replacement Surgery

A Phase 2 study testing YM150 and Warfarin in people with Arthroplasty, Replacement, Knee, run by Astellas Pharma Inc at 54 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the safety and efficacy of twice daily dosing and once daily dosing of YM150 in subjects undergoing primary elective knee replacement surgery Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthroplasty, Replacement, Knee
What is being tested?
YM150 and Warfarin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
685 participants
Where
54 sitesin 2 countries
Study dates
May 2008to May 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is scheduled for elective primary knee arthroplasty
  • Written Informed consent obtained

Who cannot join

  • Subject has documented history of previous VTE
  • Subject is considered to be at increased risk of VTE
  • Subject has active bleeding or any condition associated with increased risk of bleeding
  • Subject is planning to have surgery on the contralateral knee at the same time or within 6 weeks after enrollment into the study

Trial locations and contacts

54 sites in 2 countries.

54 sites in 2 countries

United States44 sites

  • Study site

    Aurora, Colorado, 80012

  • Study site

    Austin, Texas, 78745

  • Study site

    Baltimore, Maryland, 21218

  • Study site

    Bay Pines, Florida, 33744

  • Study site

    Boise, Idaho, 83702

  • Study site

    Bradenton, Florida, 34209

  • Study site

    Charleston, South Carolina, 29414

  • Study site

    Cincinnati, Ohio, 45242

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Dallas, Texas, 75231

  • Study site

    Decatur, Georgia, 30033

  • Study site

    Denver, Colorado, 80230

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Grapevine, Texas, 76051

  • Study site

    Gulf Breeze, Florida, 32561

  • Study site

    Hollywood, Florida, 33021

  • Study site

    Houston, Texas, 77030

  • Study site

    Idaho Falls, Idaho, 83404

  • Study site

    La Mesa, California, 91942

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Lone Tree, Colorado, 80124

  • Study site

    Long Beach, California, 90806

  • Study site

    Long Beach, California, 90822

  • Study site

    Lubbock, Texas, 79410

  • Study site

    Lubbock, Texas, 79412

  • Study site

    Mobile, Alabama, 36608

  • Study site

    Odessa, Texas, 79761

  • Study site

    Phoenix, Arizona, 85023

  • Study site

    Richmond, Virginia, 23249

  • Study site

    Richmond, Virginia, 23294

  • Study site

    San Antonio, Texas, 78217

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Diego, California, 92128

  • Study site

    Santa Ana, California, 92074

  • Study site

    Savannah, Georgia, 31405

  • Study site

    Springfield, Illinois, 62703

  • Study site

    Springfield, Illinois, 62794

  • Study site

    St. Petersburg, Florida, 33703

  • Study site

    St. Petersburg, Florida, 33713

  • Study site

    Torrance, California, 90502

  • Study site

    Tulsa, Oklahoma, 74146

  • Study site

    Tuscon, Arizona, 85712

  • Study site

    Washington D.C., District of Columbia, 20017

  • Study site

    Yuba City, California, 95991

Other trials in United States

Canada10 sites

  • Study site

    Ajax, Ontario, L1S 2J5

  • Study site

    Burlington, Ontario, L7R 4B7

  • Study site

    Charlottetown, Prince Edward Island, C1A 1L2

  • Study site

    Montreal, Ontario, H1T 2M4

  • Study site

    Newmarket, Ontario, L3Y 2P9

  • Study site

    Red Deer, Alberta, T4N 4E7

  • Study site

    Saint Catherines, Ontario, L2R 7P3

  • Study site

    Scarborough Village, Ontario, M1E 5E9

  • Study site

    Thunder Bay, Ontario, P7B 6V4

  • Study site

    Waterloo, Ontario, N2J 1CA

Other trials in Canada

About this study

Official title: A Phase 2b, Double-Blind, Double-Dummy, Randomized, Parallel Group Study to Evaluate the Safety and Efficacy of Twice Daily Dosing and Once Daily Dosing of YM150 in Subjects Undergoing Primary Elective Knee Arthroplasty

To evaluate the safety and efficacy of twice daily dosing and once daily dosing of YM150 in subjects undergoing primary elective knee replacement surgery

Being tested
YM150, Warfarin
Keywords
Knee Arthroplasty, Factor Xa, VTE, Thrombosis, Anticoagulants
Medical subject headings
Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00595426
Study groupRoleWhat they receive
1. YM150 Dose X, twice dailyExperimentalNot described
Receives: Drug: YM150
2. YM150 Dose Y, once dailyExperimentalNot described
Receives: Drug: YM150
3. YM150 Dose Y, twice dailyExperimentalNot described
Receives: Drug: YM150
4. YM150 Dose Z, once dailyExperimentalNot described
Receives: Drug: YM150
5. WarfarinActive comparatorvarious doses
Receives: Drug: Warfarin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of total venous thromboembolisms (VTE).

    Measured: 6 Weeks

  2. The incidence of bleeding events classified as major by the Adjudication Committee

    Measured: 6 Weeks

Secondary outcomes (2)

  1. Evaluation of efficacy variables including: Proximal VTE, Distal VTE, Confirmed symptomatic VTE, death due to any cause

    Measured: 6 Weeks

  2. Incidence of the bleeding types: major, clinically relevant nonmajor, minor

    Measured: 6 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionMay 2009
  4. Study completionMay 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
685 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00595426
Sponsor's protocol ID
150-CL-033
Acronym
PEARL
Status last verified
May 2010
First submitted
7 Jan 2008
Last updated
25 Mar 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing YM150 and Warfarin in people with Arthroplasty, Replacement, Knee, run by Astellas Pharma Inc at 54 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of total venous thromboembolisms (VTE). (time frame: 6 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00595426.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2013; AzTrials last refreshed its copy on 7 Nov 2026.

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