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

NCT00480636

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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.
Show details

- 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.
Show details


- 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.

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Acute Deep Vein ThrombosisFragmin In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism In Cancer Patients NCT00480636
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Fragmin In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism In Cancer Patients
Official Title Fragmin 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 Summary To collect postmarketing data about Fragmin safety and efficacy in the treatment of deep vein thrombosis with or without pulmonary embolism in cancer patients.
Detailed Description Method: 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The patients are identified in primary care setting.
Condition Acute Deep Vein Thrombosis
Intervention Drug: 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/Cohorts One 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 Status Completed
Actual Enrollment
 (submitted: July 14, 2010)
102
Original Enrollment
 (submitted: May 29, 2007)
100
Actual Study Completion Date June 2009
Actual Primary Completion Date June 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
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries Slovakia
 
Administrative Information
NCT Number NCT00480636
Other Study ID Numbers A6301082
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2010