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Evaluation of Dalteparin for Long-term (One Year) Treatment of Blood Clots in Subjects With Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00942968
First received: July 16, 2009
Last updated: January 4, 2017
Last verified: January 2017
Results First Received: January 4, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cancer
Intervention: Drug: dalteparin

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Dalteparin Sodium Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.

Participant Flow:   Overall Study
    Dalteparin Sodium
STARTED   338 
Treated   334 
COMPLETED   109 
NOT COMPLETED   229 
Adverse Event                60 
Death                76 
Protocol Violation                9 
Lost to Follow-up                4 
Withdrawal by Subject                44 
Sponsor request                5 
Physician Decision                11 
Progression of disease                12 
Inferior vena cava filter placement                4 
Pulmonary embolism (PE)                1 
Participant required pancreatic biopsy                1 
Deep vein thrombosis (DVT)                2 



  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.
Safety population included all participants who received at least 1 treatment with dalteparin sodium.

Reporting Groups
  Description
Dalteparin Sodium Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.

Baseline Measures
   Dalteparin Sodium 
Overall Participants Analyzed 
[Units: Participants]
 334 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.8  (10.63) 
Gender 
[Units: Participants]
Count of Participants
 
Female      171  51.2% 
Male      163  48.8% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Major Bleeding Events Adjudicated by Central Adjudication Committee   [ Time Frame: Month 2 up to Month 6 ]

2.  Primary:   Number of Participants With Major Bleeding Events Adjudicated by Central Adjudication Committee   [ Time Frame: Month 7 up to Month 12 ]

3.  Primary:   Number of Participants With New or Recurrent Venous Thromboembolism (VTE) Adjudicated by Central Adjudication Committee   [ Time Frame: Month 7 up to Month 12 ]

4.  Secondary:   Number of Participants With Investigator Identified Major Bleeding Events   [ Time Frame: Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12 ]

5.  Secondary:   Number of Participants With Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee   [ Time Frame: Month 1 up to Month 6, Month 7 up to Month 12, Month 1 up to Month 12, Month 2 up to Month 6, and Month 2 up to Month 12 ]

6.  Secondary:   Number of Participants With Fatal Bleeding Events   [ Time Frame: Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12 ]

7.  Secondary:   Time to First Occurrence of Major Bleeding Event Adjudicated by Central Adjudication Committee   [ Time Frame: Month 1 up to Month 12 ]

8.  Secondary:   Time to First Occurrence of Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee   [ Time Frame: Month 1 up to Month 12 ]

9.  Secondary:   Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTEs)   [ Time Frame: Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12 ]

10.  Secondary:   Number of Participants With New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT) Adjudicated by Central Adjudication Committee   [ Time Frame: Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12 ]

11.  Secondary:   Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT)   [ Time Frame: Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12 ]

12.  Secondary:   Time to First Occurrence of New or Recurrent Venous Thromboembolism (VTE) Adjudicated by Central Adjudication Committee   [ Time Frame: Month 1 up to Month 12 ]

13.  Secondary:   Time to First Occurrence of New or Recurrent VTE or CVT Adjudicated by Central Adjudication Committee   [ Time Frame: Month 1 up to Month 12 ]

14.  Other Pre-specified:   Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline (Day 1) up to Week 52 ]

15.  Other Pre-specified:   Number of Participants With Clinically Significant Laboratory Abnormalities   [ Time Frame: Baseline (Day 1) up to Week 52 ]

16.  Other Pre-specified:   Number of Participants With Abnormal Physical Examinations Findings   [ Time Frame: Baseline (Day 1), Week 1, 4, 8, 12, 24, 36, 48, 52 ]

17.  Other Pre-specified:   Other Pre-specified: Number of Participants With Clinically Significant Electrocardiogram Findings   [ Time Frame: Baseline up to Week 52 ]

18.  Other Pre-specified:   Change From Baseline in Creatinine Clearance at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 in Severely Renal Impaired Participants   [ Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 ]


  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
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  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: Pfizer ClinicalTrials.gov
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00942968     History of Changes
Other Study ID Numbers: FRAG-A001-401
A6301095 ( Other Identifier: Alias Study Number )
Study First Received: July 16, 2009
Results First Received: January 4, 2017
Last Updated: January 4, 2017