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Клинические исследования в Украине

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Исследования / № 00694382

Описание
Краткое названиеEvaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy
Полное названиеA Multinational, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AVE5026 in the Prevention of Venous Thromboembolism (VTE) in Cancer Patients at High Risk for VTE and Who Are Undergoing Chemotherapy
СпонсорSanofi-Aventis
Industry
ИсточникSanofi-Aventis
Под контролемUnited States: Food and Drug Administration
Yes
Краткое описаниеThe primary objective is to compare the efficacy of once daily (q.d.) subcutaneous (s.c.)
injections of AVE5026 with placebo in the prevention of venous thromboembolism (VTE) in
cancer patients at high risk for VTE and who are undergoing chemotherapy.

The secondary objectives are to evaluate the safety of AVE5026, to document AVE5026
exposures, to try identifying a metagene predictor of VTE and to assess the survival status
at one year in this population.
СостояниеЗавершено
Дата началаJune 2008
ФазаPhase 3
Подробное описаниеThe study treatment duration is variable depending on the duration of chemotherapy.
Вид исследованияAllocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Набор0
КритерииInclusion Criteria:

- Cancer patients with metastatic or locally advanced solid tumor of lung, pancreas,
stomach, colon/rectum, bladder or ovary

- initiating a (new) course of chemotherapy with a minimum intent of 3 months therapy

Exclusion Criteria:

- Subject requiring systematic venous thromboprophylaxis or curative treatment with
anti-coagulant or thrombolytic

- Patients at high risk of bleeding

- Severe renal impairment (estimated creatinine clearance < 30 mL/min)

- ECOG (Eastern Cooperative Oncology Group) performance status 3 & 4

- Known hypersensitivity to UFH or LMWH

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial
ПолBoth
Минимальный возраст18 Years
Максимальный возрастN/A
УсловиеPrevention of Venous Thromboembolism
Применяемое лечение
DrugSemuloparin sodium (AVE5026)
DrugPlacebo
Контакты и расположение
Cherkasy Sanofi-Aventis Investigational Site Number 804008
Chernivtsi Sanofi-Aventis Investigational Site Number 804009
Dnipropetrovsk Sanofi-Aventis Investigational Site Number 804002
Donetsk , 83092Sanofi-Aventis Investigational Site Number 804006
Kiev Sanofi-Aventis Investigational Site Number 804007
Krivoy Rog , 50048Sanofi-Aventis Investigational Site Number 804005
Lugansk , 91047Sanofi-Aventis Investigational Site Number 804003
Lutsk , 43018Sanofi-Aventis Investigational Site Number 804001
Lviv , 79031Sanofi-Aventis Investigational Site Number 804010
Sumy Sanofi-Aventis Investigational Site Number 804011
Ternopil , 46023Sanofi-Aventis Investigational Site Number 804004
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