Enoxaparin in Acute Venous Thromboembolic Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00265993
• Date of registration: 14/12/2005
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Enoxaparin in Acute Venous Thromboembolic Disease
• Scientific 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
• Date of first enrolment: December 2004
• Target sample size: 251
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00265993
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Turkey

Contacts

• Name: Edibe Taylan
• Affiliation: Sanofi

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Venous Thrombosis

Intervention(s)

Drug: enoxaparin

Primary Outcome(s)

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. [Time Frame: 3 months]

Secondary ID(s)

XRP4563A_4001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors