Odiparcil For The Prevention Of Venous Thromboembolism

NCT00244725 | Completed Phase 2 Results

• 1 other identifier: ITI101711
• Study Type: interventional
• Target: 961
• Locations: 13 countries
• Sites: 101

Brief Summary

Odiparcil is being studied to determine if it can prevent blood clots from forming after a total knee replacement and also to prove that odiparcil is safe.

Conditions

Deep Vein Thrombosis; Fibrillation, Atrial; Venous Thromboembolism; Pulmonary Embolism

Keywords

deep vein thrombosis; total knee replacement; PE; Venous thromboembolism; DVT; pulmonary embolism; VTE

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Total VTE Event Over 10 ± 2 Days of Treatment

  Participants were assessed for VTE at all study visits and at the end of study (Day 10±2) or at early withdrawal. Any participant who remained asymptomatic for VTE at the end of the study did not receive a mandatory bilateral venogram following at least 8 days on study medication. Participants who were withdrawn early and had been objectively confirmed to have a VTE event by a method other than venography were not required to undergo venography. A participant was included in the Independent Central Adjudication Committee (ICAC)-adjudicated incidence of total VTE if he/ she experienced any of adjudicated asymptomatic deep vein thrombosis (DVT) at early withdrawal or after 8-12 days of study treatment and no later than 1 day after end of study treatment, adjudicated symptomatic DVT or pulmonary embolism (PE) at any time during study treatment or death adjudicated to be related to VTE during study treatment.

  Up to Visit 7 (10 ± 2 days of treatment)

Secondary Outcomes (11)

• Percentage of Participants With Proximal DVT Over 10 ± 2 Days of Treatment

  Up to 12 days

• Percentage of Participants With Distal DVT Over 10 ± 2 Days of Treatment

  Up to 12 days

• Percentage of Participants With PE Over 10 ± 2 Days of Treatment

  Up to 12 days

• Number of Death Due to VTE Over 10 ± 2 Days of Treatment

  Up to 12 days

• Percentage of Participants With Total Asymptomatic VTE Over 10 ± 2 Days of Treatment

  Up to 12 days

Interventions

Odiparcil DRUG

Warfarin DRUG

Coumadin DRUG

Also known as: Odiparcil, Warfarin

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women must be unable to have children.
• Will have a total knee replacement.

You may not qualify if:

• Allergic to any X-ray dye.
• Allergies or reactions to warfarin or coumadin.
• Previous VTE (venous thromboembolism) or deep vein thrombosis (DVT).
• On anticoagulation therapy.
• Renal impairment.
• Participated in any clinical trial in the past 30 days.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (101)

GSK Investigational Site

Birmingham, Alabama, 35209, United States

Location

GSK Investigational Site

Mobile, Alabama, 36608, United States

Location

GSK Investigational Site

Phoenix, Arizona, 85023, United States

Location

GSK Investigational Site

Little Rock, Arkansas, 72205, United States

Location

GSK Investigational Site

Banning, California, 92220, United States

Location

GSK Investigational Site

Sacramento, California, 95817, United States

Location

GSK Investigational Site

Torrance, California, 90509, United States

Location

GSK Investigational Site

Yuba City, California, 95991, United States

Location

GSK Investigational Site

Colorado Springs, Colorado, 80907, United States

Location

GSK Investigational Site

Lonetree, Colorado, 80124, United States

Location

GSK Investigational Site

Clearwater, Florida, 33756, United States

Location

GSK Investigational Site

DeLand, Florida, 32720, United States

Location

GSK Investigational Site

Jacksonville, Florida, 32216, United States

Location

GSK Investigational Site

Sarasota, Florida, 34239, United States

Location

GSK Investigational Site

Sarsota, Florida, 34239, United States

Location

GSK Investigational Site

St. Petersburg, Florida, 33701, United States

Location

GSK Investigational Site

Decatur, Georgia, 30033, United States

Location

GSK Investigational Site

Boise, Idaho, 83702, United States

Location

GSK Investigational Site

Lexington, Kentucky, 40509, United States

Location

GSK Investigational Site

Baton Rouge, Louisiana, 70808, United States

Location

GSK Investigational Site

Baltimore, Maryland, 21209, United States

Location

GSK Investigational Site

Baltimore, Maryland, 21215-5271, United States

Location

GSK Investigational Site

Baltimore, Maryland, 21218, United States

Location

GSK Investigational Site

Warren, Michigan, 48089, United States

Location

GSK Investigational Site

Mineola, New York, 11501, United States

Location

GSK Investigational Site

Charlotte, North Carolina, 28207, United States

Location

GSK Investigational Site

Durham, North Carolina, 27704, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45242, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44195, United States

Location

GSK Investigational Site

Toledo, Ohio, 43614, United States

Location

GSK Investigational Site

Allentown, Pennsylvania, 18103, United States

Location

GSK Investigational Site

Altoona, Pennsylvania, 16601, United States

Location

GSK Investigational Site

Camp Hill, Pennsylvania, 17011, United States

Location

GSK Investigational Site

Hershey, Pennsylvania, 17033, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19107, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19140, United States

Location

GSK Investigational Site

Dallas, Texas, 75231, United States

Location

GSK Investigational Site

Dallas, Texas, 75246, United States

Location

GSK Investigational Site

Lubbock, Texas, 79410, United States

Location

GSK Investigational Site

San Antonio, Texas, 78217, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

Norfolk, Virginia, 23507, United States

Location

GSK Investigational Site

Richmond, Virginia, 23229, United States

Location

GSK Investigational Site

Richmond, Virginia, 23249, United States

Location

GSK Investigational Site

Huntington, West Virginia, 25701, United States

Location

GSK Investigational Site

Marshfield, Wisconsin, 54449, United States

Location

GSK Investigational Site

Camperdown, New South Wales, 2050, Australia

Location

GSK Investigational Site

Southport, Queensland, 4215, Australia

Location

GSK Investigational Site

Box Hill, Victoria, 3128, Australia

Location

GSK Investigational Site

Clayton, Victoria, 3168, Australia

Location

GSK Investigational Site

Geelong, Victoria, 3220, Australia

Location

GSK Investigational Site

Ringwood East, Victoria, 3135, Australia

Location

GSK Investigational Site

Windsor, Victoria, 3181, Australia

Location

GSK Investigational Site

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

GSK Investigational Site

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

GSK Investigational Site

Winnipeg, Manitoba, R3J 3M7, Canada

Location

GSK Investigational Site

Ajax, Ontario, L1S 2J5, Canada

Location

GSK Investigational Site

Don Mills, Ontario, M3C 1W3, Canada

Location

GSK Investigational Site

Newmarket, Ontario, L3Y 2P9, Canada

Location

GSK Investigational Site

North York, Ontario, M3M 2G2, Canada

Location

GSK Investigational Site

Oshawa, Ontario, L1G 2B9, Canada

Location

GSK Investigational Site

Scarborough Village, Ontario, M1W 3W3, Canada

Location

GSK Investigational Site

Waterloo, Ontario, N2J 1C4, Canada

Location

GSK Investigational Site

Charlottetown, Prince Edward Island, C1A 1L2, Canada

Location

GSK Investigational Site

Montreal, Quebec, H1T 2M4, Canada

Location

GSK Investigational Site

Québec, Quebec, G1J 1Z4, Canada

Location

GSK Investigational Site

Sainte Jerome, Quebec, J7Z 5T3, Canada

Location

GSK Investigational Site

Chennai, 600 040, India

Location

GSK Investigational Site

Secunderabad, 500 003, India

Location

GSK Investigational Site

Haifa, 31096, Israel

Location

GSK Investigational Site

Kfar Saba, 44281, Israel

Location

GSK Investigational Site

Petah Tikva, 49372, Israel

Location

GSK Investigational Site

Tel Aviv, 64239, Israel

Location

GSK Investigational Site

Riga, LV1004, Latvia

Location

GSK Investigational Site

Riga, LV1005, Latvia

Location

GSK Investigational Site

Kaunas, LT-50009, Lithuania

Location

GSK Investigational Site

Klaipėda, LT-92288, Lithuania

Location

GSK Investigational Site

Vilnius, LT-04128, Lithuania

Location

GSK Investigational Site

Bialystok, 15-276, Poland

Location

GSK Investigational Site

Krakow, 31-862, Poland

Location

GSK Investigational Site

Sosnowiec, 41-200, Poland

Location

GSK Investigational Site

Wroclaw, 50-043, Poland

Location

GSK Investigational Site

Irkutsk, 664003, Russia

Location

GSK Investigational Site

Kurgan, 640014, Russia

Location

GSK Investigational Site

Moscow, 117415, Russia

Location

GSK Investigational Site

Mosocow, 115516, Russia

Location

GSK Investigational Site

Mosocow, 117593, Russia

Location

GSK Investigational Site

Rostov-on-Don, 344718, Russia

Location

GSK Investigational Site

Pretoria, Gauteng, 0084, South Africa

Location

GSK Investigational Site

Centurion, 157, South Africa

Location

GSK Investigational Site

Pretoria, South Africa

Location

GSK Investigational Site

Cherkasy, 18009, Ukraine

Location

GSK Investigational Site

Dnipro, 49005, Ukraine

Location

GSK Investigational Site

Kyiv, 03103, Ukraine

Location

GSK Investigational Site

Kyiv, 04107, Ukraine

Location

GSK Investigational Site

Vinnitsa, 21032, Ukraine

Location

GSK Investigational Site

Birmingham, West Midlands, B18 7QH, United Kingdom

Location

GSK Investigational Site

Bournmouth, BH7 7DW, United Kingdom

Location

GSK Investigational Site

Fife, KY2 5AH, United Kingdom

Location

GSK Investigational Site

London, SE5 9JP, United Kingdom

Location

GSK Investigational Site

Wigan, WN6 9EP, United Kingdom

Location

MeSH Terms

Conditions

Venous Thrombosis; Atrial Fibrillation; Venous Thromboembolism; Pulmonary Embolism

Interventions

odiparcil; Warfarin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thromboembolism; Lung Diseases; Respiratory Tract Diseases; Embolism

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2005
• First Posted: October 27, 2005
• Study Start: September 1, 2005
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: May 2, 2017
• Results First Posted: May 2, 2017

Record last verified: 2017-03

Locations

LA (2); GB (5); IN (2); AU (7); US (46); LI (3); UA (5); IL (4); CA (12); PL (4); BR (2); RU (6); ZA (3)