CTRI/2008/091/000277已完成3 期
A Multinational Randomized Double Blind, Placebo-controlled study to evaluate the efficacy and safety of AVE5026 in the prevention of Venous Thromembolism(VTE) in cancer patients at high risk for VTE and who are undergoing chemotherapy
Sanofi Synthelabo I Ltd2 个研究点 分布在 1 个国家目标入组 3,200 人开始时间: 2008年10月14日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,200
- 试验地点
- 2
- 主要终点
- The primary efficacy endpoint is the time-to-first occurrence of any component of the composite endpoint of the following documented outcome results, confirmed by a blinded Adjudication Committee, occurring from randomization up to 3 calendar days after last study drug injection: - Any symptomatic DVT of the lower limbs - Any symptomatic DVT of the upper limbs (including CVC-related thrombosis) - Any non fatal PE - VTE-related deaths (fatal PE or unexplained deaths)
研究概览
简要总结
Trial will be conducted in 46 countries all over the world.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The primary efficacy endpoint is the time-to-first occurrence of any component of the composite endpoint of the following documented outcome results, confirmed by a blinded Adjudication Committee, occurring from randomization up to 3 calendar days after last study drug injection: - Any symptomatic DVT of the lower limbs - Any symptomatic DVT of the upper limbs (including CVC-related thrombosis) - Any non fatal PE - VTE-related deaths (fatal PE or unexplained deaths)
时间窗: 7 Months
次要结局
- Other efficacy outcomes include each component of the primary(efficacy endpoint, from randomization up to 3 calendar days after last)
研究者
研究点 (2)
Loading locations...
相似试验
终止
2 期
Use of Activated Recombinant Human Factor VII in Cardiac SurgeryAcquired Bleeding DisorderCardiac Surgery Requiring Cardiopulmonary BypassNCT00154427Novo Nordisk A/S172
终止
3 期
Efficacy and Safety of COVID-19 Vaccine as Booster Vaccination in Adults 18 Years of Age or OlderCOVID-19NCT05683600Guangzhou Patronus Biotech Co., Ltd.3,000
已完成
3 期
Recombinant Factor VIIa in Acute Intracerebral HaemorrhageAcquired Bleeding DisorderIntracerebral HaemorrhageNCT00127283Novo Nordisk A/S829
已完成
2 期
A clinical trial to study the effect of Docetaxel when added to standard treatment (Cisplatin and 5-FluroUracil) in Nasopharyngeal Carcinoma in children and adolescents.CTRI/2008/091/000007Sanofi Synthelabo India Limited72
已完成
4 期
A randomized, multicentre, double-blind, parallel, sham-controlled study of the gammaCore®, a non-invasive neurostimulator device for the acute relief of episodic and chronic cluster headache.cluster headaches10019231NL-OMON40599electroCore LLC35