Phase IV Study to Compare Efficacy and Safety of Plavix 75mg With Astrix 100mg and Closone

NCT01765452 | Completed Phase 4

• 1 other identifier: CJ_CLO_401
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 7

Brief Summary

The Aim of this study is to prove non-inferiority of Closone to the Combination treatment of Plavix with Astrix.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Change from baselinine in P2Y12% inhibition at week 8

  Baseline, week 8

Secondary Outcomes (1)

• Change from baseline in PRU, ARU at week 8

  Baseline, week 8

Study Arms (2)

Closone

EXPERIMENTAL

75mg/100mg per day, 8weeks, PO

Drug: Closone

Plavix with Astrix

ACTIVE COMPARATOR

75mg per day, 8weeks, PO 100mg per day, 8weeks, PO

Drug: Plavix with Astrix

Interventions

Closone DRUG

75mg/100mg, 8weeks, PO

Closone

Plavix with Astrix DRUG

75mg, 100mg a day, 8weeks, PO

Plavix with Astrix

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects under a stable condition after Post-Percutaneous Coronary Artery Intervention over three months
• \~86 years old
• Willing to adhere to protocol requirements and sign a informed consent form

You may not qualify if:

• Subject who did not undergo or failed Drug-Stent Implantation
• Subjects who took an anti-coagulant, anti-thrombotic regularlly( ≥ 2weeks in a month) before the study, or plan to have continuous treatment during the study(Except Aspirin alone or combination of Aspirin and Clopidogrel)
• Subjects with a history of substance or alchol abuse
• Subjects with a history of hypersensitivity to Clopidogrel, Aspirin or other NSAIDS
• Subjects having Aspirin or other NSAIDs-induced Asthma or history
• Subjects with Severe hepatopathy(AST and ALT \> 5 times the upper limit of normal)
• Subjects with Severe nephropathy(Cr \> 3 times the upper limit of normal)
• Subjects with hemorrhage like gastric ulcer, intracranial hemorrhage etc.
• Subjects with high risk of hemorrhage like blood coagulation disorders, uncontrolled severe hypertension, active bleeding, history of severe bleeding
• subjects who are pregnant, breastfeeding
• Subjects not using medically acceptable birth control
• Subjects who are unsuitable to take the Investigational product due to a medical/mental condition
• Subjects inherently having Galactose malobsorption, Lactase deficiency or Glucose-Galactose malobsorption

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (7)

Inje university haeundae paik hospital

Busan, South Korea

Location

Kosin university gospel hospital

Busan, South Korea

Location

Pusan national university hospital

Busan, South Korea

Location

Dongguk University Medical Center

Gyeonggi-do, South Korea

Location

Chungbuk national university hospital

Jungbuk, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

SNU Boramae Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: January 10, 2013
• Study Start: October 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: May 12, 2014

Record last verified: 2014-05

Locations

KR (7)