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Last Updated: January 24, 2021

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CLINICAL TRIALS PROFILE FOR INDOBUFEN

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Clinical Trials for Indobufen

Trial ID Title Status Sponsor Phase Summary
NCT00244426 S.I.F.A. II: Prevention Of Thromboembolic Events In Patients With Nonrheumatic Atrial Fibrillation Completed Pfizer Phase 3 Evaluate efficacy and safety of Indobufen v. Aspirin in preventing thromboembolic events in patients at high risk of CV events such as patients suffering from nonrheumatic atrial fibrillation.
NCT01232023 Evaluation of Pharmacokinetic and Pharmacodynamic Characteristics of Indobufen, an Anticoagulant Agent Unknown status Asan Medical Center Phase 1 This study is designed to evaluate the pharmacokinetic and pharmacodynamic characteristics of indobufen in healthy subjects.
NCT01256775 Effect of NCX4016 on Walking Distance in Patients With Peripheral Arterial Occlusive Disease (PAOD) Completed NicOx Research Institute S.r.l. Phase 2 Peripheral arterial disease (PAD) is almost invariably associated with a generalized atherosclerotic involvement of the arterial tree and endothelial dysfunction. Previous short term studies showed improvement of vascular reactivity and walking capacity in PAD patients by measures aimed at restoring Nitric Oxide (NO) production. NO is also known to prevent the progression of atherosclerosis. We wished to assess whether the prolonged administration of a NO-donating agent (NCX 4016) improves the functional capacity of PAD patients and affects the progression of atherosclerosis as assessed by carotid intima-media thickness (IMT). Four hundred forty two patients with stable intermittent claudication were enrolled in a prospective, double blind, placebo-controlled study and randomized to either NCX 4016 800mg bid or its placebo for 6 months. The primary study outcome was the absolute claudication distance (ACD) on a constant treadmill test (10% incline, 3km/hr); main secondary end-point was the change of the mean far-wall right common carotid artery IMT.
NCT03230851 the Efficacy and Safety of Indobufen and Low-dose Aspirin in Different Regimens of Antiplatelet Therapy Not yet recruiting The First Affiliated Hospital with Nanjing Medical University Phase 4 A total of 210 coronary atherosclerosis patients without indications for stent implantation are included. The baseline values of platelet aggregation rate, plasma TXB2 and urinary 11-dh TXB2 are measured by LTA method and ELISA after aspirin 100 mg /d ≥5d. Then the patients are randomly divided into 7 groups: Group1: aspirin 100 mg/d; Group2: aspirin 100 mg /2d; Groups3: aspirin 100 mg / 3d; Groups4: morning 50mg evening 50mg; Group5: aspirin 75mg / d; Group6: aspirin 50mg / d; Group7: indobufen100mg bid. One month later,arachidonic acid-induced platelet aggregation rate , plasma TXB2 and urine 11-dh TXB2 are anylized again. All patients are fellowed-up for 1 year. The stomach Intestinal reactions, small bleeding events are recorded.
NCT03871517 INdobufen Versus aSpirin in acUte Ischemic stRokE,INSURE Not yet recruiting Ministry of Science and Technology of the People´s Republic of China Phase 4 China has the largest burden of cerebrovascular disease in the world. About 60% to 80% of which are ischemic stroke. In recent years, stroke has replaced heart disease and tumor diseases as the first cause of death and disability in adult population. The primary purpose of this study is to evaluate the efficacy of indobufen treatment in reducing the risk of a 3-month new stroke (any type of stroke, including ischemic stroke and hemorrhagic stroke) for patients with moderate/severe ischemic stroke is not inferior to aspirin therapy.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Indobufen

Condition Name

Condition Name for
Intervention Trials
Coronary Atherosclerosis 1
Stable Coronary Heart Disease 1
Coronary Artery Disease 1
Ischemic Stroke 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Coronary Artery Disease 3
Myocardial Ischemia 2
Stroke 1
Intermittent Claudication 1
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Clinical Trial Locations for Indobufen

Trials by Country

Trials by Country for
Location Trials
Italy 8
China 2
Korea, Republic of 1
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Clinical Trial Progress for Indobufen

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 4 3
Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Not yet recruiting 4
Completed 2
Unknown status 1
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Clinical Trial Sponsors for Indobufen

Sponsor Name

Sponsor Name for
Sponsor Trials
The First Affiliated Hospital with Nanjing Medical University 1
NicOx Research Institute S.r.l. 1
Asan Medical Center 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Other 5
Industry 2
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