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.
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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