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

Last updated on November 9, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Deep Vein Thrombosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Male or female patient of 18 - 70 years of age.

- Cancer patient with proven deep-vein thrombosis with or without pulmonary embolism
confirmed by combination of clinical signs and symptoms, pulmonary hypertension on
echocardiogram, X-ray examination of the lung and eventually perfusion/ventilation
scan of the lung.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Bleeding

- Hypersensitivity to FRAGMIN® or other low-molecular weight heparins.

- Serum creatinine level > 150 umol/l.

- Platelet count of less than 100 000 per cubic millimeter at the beginning of the
therapy.

- Patient on oral anticoagulation therapy in the last 7 days.

NCT00480636
Pfizer
Completed
Fragmin In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism In Cancer Patients

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Descriptive Information
Brief TitleFragmin In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism In Cancer Patients
Official TitleFragmin Safety And Efficacy In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism And Extended Thromboprophylaxis In Cancer Patients In Slovakia (An Open, Prospective, Non-Comparative Study)
Brief SummaryTo collect postmarketing data about Fragmin safety and efficacy in the treatment of deep vein thrombosis with or without pulmonary embolism in cancer patients.
Detailed DescriptionMethod: consecutive patient sampling. Patients were (are) included in the study in consecutive manner if they fulfilled the inclusion criteria and any of the exclusion criteria were not present.
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationThe patients are identified in primary care setting.
ConditionAcute Deep Vein Thrombosis
InterventionDrug: Fragmin (dalteparin sodium )
Month 1: dalteparin 200 IU/kg SC once daily. Months 2-6: dalteparin 150 IU/kg SC, once daily.
Other Name: Fragmin
Study Groups/CohortsOne cohort of patients treated with dalteparin.
About 100 patients with deep-vein thrombosis and with or without pulmonary embolism will be included in the study.
Intervention: Drug: Fragmin (dalteparin sodium )
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: July 14, 2010)
102
Original Enrollment
 (submitted: May 29, 2007)
100
Actual Study Completion DateJune 2009
Actual Primary Completion DateJune 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Male or female patient of 18 - 70 years of age.
  • Cancer patient with proven deep-vein thrombosis with or without pulmonary embolism confirmed by combination of clinical signs and symptoms, pulmonary hypertension on echocardiogram, X-ray examination of the lung and eventually perfusion/ventilation scan of the lung.

Exclusion Criteria:

  • Bleeding
  • Hypersensitivity to FRAGMIN® or other low-molecular weight heparins.
  • Serum creatinine level > 150 umol/l.
  • Platelet count of less than 100 000 per cubic millimeter at the beginning of the therapy.
  • Patient on oral anticoagulation therapy in the last 7 days.
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location CountriesSlovakia
 
Administrative Information
NCT NumberNCT00480636
Other Study ID NumbersA6301082
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer Inc
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJuly 2010

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Pfizer Clinical Trials Contact Center

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