A clinical study to evaluate the efficacy, safety and tolerability of Picotamide chewable tablets 300mg vs. Aspirin tablets 325mg in patients requiring antiplatelet therapy.
- Conditions
- Health Condition 1: D759- Disease of blood and blood-formingorgans, unspecifiedHealth Condition 2: null- Patients requiring antiplatelet therapy
- Registration Number
- CTRI/2010/091/000588
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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.
? 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Chest painTimepoint: 0th day, 4th week, 8th week and 12th week;Chest painTimepoint: 0th day, 4th week, 8th week and 12th week;Chest painTimepoint: 0th day, 4th week, 8th week and 12th week;Chest painTimepoint: 0th day, 4th week, 8th week and 12th week;Chest painTimepoint: 0th day, 4th week, 8th week and 12th week;Chest painTimepoint: 0th day, 4th week, 8th week and 12th week;Chest painTimepoint: 0th day, 4th week, 8th week and 12th week;Chest painTimepoint: 0th day, 4th week, 8th week and 12th week;Chest painTimepoint: 0th day, 4th week, 8th week and 12th week;Chest painTimepoint: 0th day, 4th week, 8th week and 12th week
- Secondary Outcome Measures
Name Time Method Global AssessmentTimepoint: 12th week;Safety and TolerabilityTimepoint: 0th day, 4th week, 8th week and 12th week
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.