Clinical Trial to Evaluate Efficacy and Safety of DP-R202 and Anplag in Patients With Artery Occlusive Disease
DAVICI
A Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase III Clinical Trial to Evaluate in Efficacy and Safety of DP-R202 and Anplag Tab in Patients With Artery Occlusive Disease
1 other identifier
interventional
151
0 countries
N/A
Brief Summary
Sarpogrelate hydrochloride, a selective 5-HT2A antagonist, has been widely used as an anti-platelet agent for the treatment of PAD. DP-R202 is a new Sarpogrelate hydrochloride product improved patient's convenience and disadvantage of dosage regimen of previous drug. The aim of this study was to compare the efficacy and safety of DP-R202 and Anplag® Tab in patients with PAD
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2012
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 12, 2015
CompletedFirst Posted
Study publicly available on registry
March 19, 2015
CompletedNovember 1, 2016
March 1, 2015
1.5 years
March 12, 2015
October 31, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Variation in lower limb pain (VAS)
12 weeks
Study Arms (2)
DP-R202
EXPERIMENTALPatients administrate DP-R202 (Sarpogrelate 300mg) once a day for 12 weeks
Anplag tab
ACTIVE COMPARATORPatients administrate Anplag tab (Sarpogrelate 100mg) 3 times a day for 12 weeks
Interventions
Sarpogrelate HCl SR 300mg is administrated to patients with PAD for 12 weeks
Eligibility Criteria
You may qualify if:
- Lower limb pain degree is over 40 mm evaluated by VAS at screening
- ABI (ankle-brachial index) ≤0.9
You may not qualify if:
- Patients with peripheral related surgery within 1 month of clinical study participation
- Fontaine stage 4, NYHA class 3-4
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alvogen Korealead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2015
First Posted
March 19, 2015
Study Start
October 1, 2012
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
November 1, 2016
Record last verified: 2015-03
Data Sharing
- IPD Sharing
- Will not share