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临床试验/CTRI/2010/091/000588
CTRI/2010/091/000588已完成3 期

A comparative, randomized, open label, multicentric, clinical study to evaluate the efficacy, safety and tolerability of Picotamide chewable tablets 300mg vs. Aspirin tablets 325mg in patients requiring antiplatelet therapy.

Ajanta Pharma Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
已完成
入组人数
200

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1.Patients having signs and symptoms of any of the following: - diabetes/ obesity/ hypertension/ high blood cholesterol/ family history of heart disease, artery disease or blood disorders /cigarette smoking, tobacco chewing, alcohol consumption.
  • 2.High platelet aggregation as per platelet aggregometry.
  • 3.Written informed consent by patient participating in the trial.

排除标准

  • ? Males or females < 18 years of age.
  • ? Recent significant trauma or surgical interventions.
  • ? Subjects will be excluded if they used NSAIDs within one week prior to the study, have renal insufficiency, inflammatory disorders such as rheumatologic conditions, autoimmune disorders, active infections, malignancy or if they are undergoing chemotherapy.
  • ? Uncontrolled hypertension.
  • ? History of bleeding disorders.
  • ? Pregnant, possibly pregnant, or lactating females.
  • ? Participation in clinical trial with an investigation drug within 30 days proceeding day one of this study.
  • ? Any condition that in the opinion of the investigator, does not justify the patient?s inclusion in the study.
  • ? History of hypersensitivity to the study drug or similar class of drug.

研究者

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