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Enoxaparin in Acute Venous Thromboembolic Disease

Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Venous Thrombosis

Intervention: enoxaparin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Edibe Taylan, Study Director, Affiliation: Sanofi

Summary

Study objectives :

- To evaluate the efficacy/safety profile of enoxaparin once a day treatment in acute

venous thromboembolic disease.

Clinical Details

Official title: The Efficacy of Subcutaneous Enoxaparin Once Daily in the Treatment of Acute Venous Thromboembolic Disease: an Open-labelled, Non-comparative, Multicentric, Phase IV Trial

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Frequency of bleeding emerged during the study drug administration; Frequency of bleeding emerged during 3 months of monitorization when the patient is on oral anticoagulants.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with symptomatic lower-extremity deep venous thrombosis confirmed by doppler

USG (ultrasonography), with or without confirmed symptomatic pulmonary embolism associated with provoked risk factors Exclusion Criteria:

- Patients with a history of heparin or warfarin treatment longer than 24 hours,

- Patients requiring thrombolytic treatment,

- Patients having thrombophilia diagnosis,

- Patients with prior deep vein thrombosis or pulmonary emboli evidence,

- Patients with familial bleeding disorder,

- Patients who are at any known bleeding risk, such as active bleeding, active

ulcerative bowel disease, angiodysplasia and having oculary, spinal or central nervous system surgery within the last month

- Patients with renal failure (serum creatinine concentration > 180 mmol/L or > 2. 03

mg/dL),

- Patients with severe hepatic failure

- Patients with history of allergy against heparin and protamine,

- Patients with history of thrombocytopenia associated with heparin administration or

of skin necrosis after heparin or warfarin treatment,

- Patients participating in another clinical study within the last 4 months

- Patients who are pregnant

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations and Contacts

Sanofi-Aventis Administrative Office, Istanbul, Turkey
Additional Information

Starting date: December 2004
Last updated: February 2, 2010

Page last updated: August 20, 2015

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