Fragmin In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism In Cancer Patients

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00480636

First received: May 29, 2007

Last updated: July 14, 2010

Last verified: July 2010

History of Changes

Results First Received: May 25, 2010

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Condition:	Acute Deep Vein Thrombosis
Intervention:	Drug: Fragmin (dalteparin sodium )

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	Dalteparin 200 International Units per kilogram (IU/kg) total body weight subcutaneously (SC) once daily (QD) for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.

Participant Flow: Overall Study

	Dalteparin
STARTED	102
COMPLETED	83
NOT COMPLETED	19
Death	12
Lost to Follow-up	4
Unspecified	2
Lost to follow-up; subsequently died	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.
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Reporting Groups

	Description
Dalteparin	Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.

Baseline Measures

	Dalteparin
Number of Participants [units: participants]	102
Age, Customized [units: Participants]
Between 18 and 44 years	4
Between 45 and 64 years	58
>= 65 years	39
Unspecified	1
Age [units: years] Mean (Standard Deviation)	61.6 (10.1)
Gender [units: Participants]
Female	54
Male	48

Outcome Measures

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1. Primary:

Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg [ Time Frame: Month 6 or End of Treatment (EOT) (up to Month 6) ]

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2. Secondary:

Number of Participants With Severe Bleeding That Resulted in a Transfusion of at Least 2 Units of Blood [ Time Frame: Baseline through Month 6 or EOT (up to Month 6) ]

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3. Secondary:

Number of Participants With Severe Bleeding That Resulted in a Decrease in Hemoglobin Level of at Least 2.0 Grams Per Deciliter (g/dL) [ Time Frame: Baseline through Month 6 or EOT (up to Month 6) ]

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4. Secondary:

Percent of Participants With and Without Pulmonary Embolism (PE) [ Time Frame: Baseline, Week 2, Month 1, Month 3, and Month 6 or EOT (up to Month 6) ]

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5. Secondary:

Number of Participants With Recurrent DVT [ Time Frame: Month 6 or EOT (up to Month 6) ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact:

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

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier:	NCT00480636 History of Changes
Other Study ID Numbers:	A6301082
Study First Received:	May 29, 2007
Results First Received:	May 25, 2010
Last Updated:	July 14, 2010
Health Authority:	Slovakia: State Institute for Drug Control

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