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Odiparcil For The Prevention Of Venous Thromboembolism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00244725
First received: October 25, 2005
Last updated: March 21, 2017
Last verified: March 2017
Results First Received: March 21, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double Blind (masked roles unspecified);   Primary Purpose: Prevention
Conditions: Deep Vein Thrombosis
Fibrillation, Atrial
Venous Thromboembolism
Pulmonary Embolism
Interventions: Drug: Odiparcil
Drug: Warfarin
Drug: Coumadin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Male or female participants >=35 years of age with scheduled for primary elective unilateral total knee arthroplasty were recruited at 82 centers from 13 countries. The study was conducted between 28 September 2005 and 27 September 2006.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 958 participants were randomized into the study. Two participants each from the treatment arm Odiparcil 250 milligram (mg), and Odiparcil 375 mg did not receive the study medication. Therefore, the intent to treat (ITT) population was comprised of 954 participants.

Reporting Groups
  Description
Odiparcil MR 250 mg Tablet Eligible participants received Odiparcil modified release (MR) 250 mg tablet at every 12 hours interval (Q12h)for the duration of 10 ± 2 days of double-blind treatment period.
Odiparcil MR 375 mg Tablet Eligible participants received Odiparcil MR 375 mg tablet at Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Odiparcil MR 500 mg Tablet Eligible participants received Odiparcil MR 500 mg tablet at Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Warfarin INR 2.0 to 3.0 Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target International Normalized Ratio (INR) of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.

Participant Flow:   Overall Study
    Odiparcil MR 250 mg Tablet   Odiparcil MR 375 mg Tablet   Odiparcil MR 500 mg Tablet   Warfarin INR 2.0 to 3.0
STARTED   237   245   239   237 
COMPLETED   214   226   215   216 
NOT COMPLETED   23   19   24   21 
Lost to Follow-up                3                4                9                2 
Withdrawal by Subject                9                7                7                8 
Not meet treatment eligibility criteria                1                2                0                0 
Physician Decision                3                0                1                2 
Adverse Events                3                1                4                4 
Withdrwal by participant                1                0                0                1 
Liver function test abnormality                2                0                0                1 
Sponsor withdrew the participant                1                0                0                1 
Mediciation Error                0                1                0                0 
Rehab Refused to allow participantion                0                1                0                0 
Headache                0                1                0                0 
Received prohibited medication                0                1                0                1 
Confirmed venous thromboembolism (VTE)                0                1                0                0 
Administrative reason                0                0                1                0 
Vomit                0                0                1                0 
Failed to follow-up                0                0                1                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Odiparcil MR 250 mg Tablet Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Odiparcil MR 375 mg Tablet Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Odiparcil MR 500 mg Tablet Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
Warfarin INR 2.0 to 3.0 Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
Total Total of all reporting groups

Baseline Measures
   Odiparcil MR 250 mg Tablet   Odiparcil MR 375 mg Tablet   Odiparcil MR 500 mg Tablet   Warfarin INR 2.0 to 3.0   Total 
Overall Participants Analyzed 
[Units: Participants]
 235   243   239   237   954 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.1  (9.53)   65.3  (8.93)   64.5  (8.68)   66.1  (9.30)   65.5  (9.12) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      150  63.8%      156  64.2%      155  64.9%      150  63.3%      611  64.0% 
Male      85  36.2%      87  35.8%      84  35.1%      87  36.7%      343  36.0% 
Race/Ethnicity, Customized 
[Units: Participants]
         
African American/African Heritage   18   17   20   12   67 
American Indian or Alaska Native   0   0   1   0   1 
Asian - Central/South Asian Heritage   3   1   3   3   10 
Asian - East Asian Heritage   0   1   1   0   2 
Asian - South East Asian Heritage   0   0   0   1   1 
White - Arabic/North African Heritage   1   0   1   0   2 
White - White/Caucasian/European Heritage   212   224   210   220   866 
Mixed Race   1   0   0   1   2 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Total VTE Event Over 10 ± 2 Days of Treatment   [ Time Frame: Up to Visit 7 (10 ± 2 days of treatment) ]

2.  Secondary:   Percentage of Participants With Proximal DVT Over 10 ± 2 Days of Treatment   [ Time Frame: Up to 12 days ]

3.  Secondary:   Percentage of Participants With Distal DVT Over 10 ± 2 Days of Treatment   [ Time Frame: Up to 12 days ]

4.  Secondary:   Percentage of Participants With PE Over 10 ± 2 Days of Treatment   [ Time Frame: Up to 12 days ]

5.  Secondary:   Number of Death Due to VTE Over 10 ± 2 Days of Treatment   [ Time Frame: Up to 12 days ]

6.  Secondary:   Percentage of Participants With Total Asymptomatic VTE Over 10 ± 2 Days of Treatment   [ Time Frame: Up to 12 days ]

7.  Secondary:   Percentage of Total Symptomatic VTE Over 10 ± 2 Days of Treatment   [ Time Frame: Up to 12 days ]

8.  Secondary:   Concentration of Trough Anti-IIa Activity Over the Duration of Treatment and Follow-up   [ Time Frame: Up to 68 days ]

9.  Secondary:   Percentage of Participants With Major Bleeds Over 10 ± 2 Days of Treatment   [ Time Frame: Up to 12 days ]

10.  Secondary:   Percentage of Participants With VTE and/or Major Bleeding Over 10±2 Days of Treatment   [ Time Frame: Up to 12 days ]

11.  Secondary:   Percentage of Participants With Total VTE Any Time After Start of Treatment   [ Time Frame: Up to Visit 9 (Day 28 post treatment) ]

12.  Secondary:   Percentage of Participants With Elevated Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Direct Bilirubin (DB) and Total Bilirubin (TB) by 2 Fold and 3 Fold From Upper Normal Limits (ULN) Any Time On-treatment   [ Time Frame: Up to 12 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00244725     History of Changes
Other Study ID Numbers: ITI101711
Study First Received: October 25, 2005
Results First Received: March 21, 2017
Last Updated: March 21, 2017