CTRI/2021/11/037831已完成3 期
A multicenter, randomized, double-blind, double dummy, Phase III study to compare safety and efficacy of fixed dose combination of Aspirin 150 mg and Pantoprazole 20 mg versus Aspirin 150mg alone for the prevention of gastroduodenal mucosal damage in patients taking aspirin for secondary prevention of cardiovascular disease or cerebrovascular disease
Alkem Laboratories Limited23 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2021年11月22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
- 240
- 试验地点
- 23
- 主要终点
- To compare proportion of patients developing gastro duodenal events in both the treatment groups.
研究概览
简要总结
A multicenter, randomized, double-blind, double dummy, Phase III study to compare safety and efficacy of fixed dose combination of Aspirin 150 mg and Pantoprazole 20 mg versus Aspirin 150mg alone for the prevention of gastroduodenal mucosal damage in patients taking aspirin for secondary prevention of cardiovascular disease or cerebrovascular disease.
Study is planned in 240 Patients Prevention of gastro duodenal mucosal damage in patients taking aspirin for secondary prevention of cardiovascular disease or cerebrovascular disease. The study duration will be approximately 1 year considering 6 months of recruitment period, 1 week screening period, 24 weeks of treatment period & 1 week follow-up period
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 55.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing to provide voluntary written informed consent.
- •Male or female patients with age ≥ 55 years at the time of screening.
- •Patients taking Aspirin ≤ 150 mg daily for ≥3 to ≤6 months and expected to require daily aspirin therapy for at least 6 months 5.Patients requiring continuous low-dose aspirin for the secondary prevention of cardiovascular disease or cerebrovascular disease a.
- •Patients diagnosed with coronary heart disease, peripheral vascular disease or ischemic stroke or transient ischemic attacks.
- •Or patients with history of: i.
- •Coronary artery bypass graft (CABG); ii.
- •Percutaneous coronary intervention (PCI) with or without stent; or iii.
- •Carotid endarterectomy.
- •Patients with 0 to 10 gastric or duodenum erosion(s) or submucosal hemorrhage(s) (Lanza Score 0 to 2).
- •Gastric and duodenal lesions will be scored using the Lanza (1988) method.
排除标准
- •Known hypersensitivity or intolerance to Aspirin, Pantoprazole or related class of drugs or any of the excipients of investigational product.
- •Concurrent erosive or ulcerative esophagitis, esophageal stricture, severe esophagitis, long-segment Barrett’s esophagus, history of serious upper Gastro-intestinal events, such as perforation, or obstruction, pyloric stenosis, previous gastric or duodenal surgery.
- •Use of corticosteroids (except the use of inhaled steroids for asthma), bisphosphonates, acid suppressants, prostaglandin analogues or anticoagulant or any other prohibited medications within last 4 weeks prior to screening or their planned co-prescription during the study participation.
- •Positive test result for H.
- •pylori at Screening.
- •Had a revascularization procedure (i.e., CABG, Percutaneous Transluminal Coronary Angioplasty, or carotid endarterectomy) less than 3 months prior to Screening.
- •Unstable hypertension as judged by Investigator.
- •Uncontrolled diabetes mellitus defined as HbA1c value > 10%.
- •Unstable cardio- or cerebrovascular disease that would endanger the subject if they participated in the trial.
- •Clinically significant valvular disease requiring treatment with anticoagulant.
- •Congestive heart failure (CHF) or other Class III or IV cardiovascular symptoms according to New York Heart Association (NYHA) Functional Classification.
- •Blood coagulation disorder.
- •Any illness with co-prescription of NSAID; Patients who have taken NSAID in last 4 weeks prior to screening.
- •Any psychiatric illness.
- •History of seizure.
- •History of alcoholism or drug addiction within a year prior to enrollment in the study.
- •Severe hepatic dysfunction (i.e., cirrhosis or portal hypertension).
- •Laboratory findings measured at screening: a.
- •Hemoglobin <10 g/dl b.
- •Neutrophils < 2000/mm3 c.
- •Platelets <100,000/mm3 d.
- •Total bilirubin > 1.5 X ULN e.
- •ALT/ AST > 2.5 X ULN f.
- •Serum creatinine >1.25 X ULN g.
- •Other than noted specifically, any screening laboratory value that is clinically significant in the Investigator’s opinion and would endanger a subject, if the subject participates in the study
- •Patients with positive serology for HIV, HBV and HCV.
- •History of malignancy, treated or untreated, within the past 5 years, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin.
- •Previous participation in any clinical trial within 1 month before the entry of the study.
- •Any condition that, in the opinion of the Investigator, may have either put the subject at risk or influenced the results of the study.
- •Pregnant or lactating women.
结局指标
主要结局
To compare proportion of patients developing gastro duodenal events in both the treatment groups.
时间窗: 12 and 24 weeks
次要结局
- Safety Endpoint:(1) Treatment emergent serious and non-serious adverse events (AEs))
- Secondary Efficacy Endpoints:(1) Mean change in Lanza Score)
研究者
研究点 (23)
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