A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HCP1303 Capsules
NCT ID: NCT02667938
Last Updated: 2016-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
510 participants
INTERVENTIONAL
2015-03-31
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment 1
HCP1303 capsule 5/0.2mg + HCP1303 capsule 5/0.4mg placebo+ HGP1201 placebo
HCP1303 capsule 5/0.2mg
HCP1303 capsule 5/0.4mg placebo
HGP1201 placebo
Treatment 2
HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg + HGP1201 placebo
HCP1303 capsule 5/0.4mg
HCP1303 capsule 5/0.2mg placebo
HGP1201 placebo
Active Comparator
HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg placebo+ HGP1201
HGP1201
HCP1303 capsule 5/0.2mg placebo
HCP1303 capsule 5/0.4mg placebo
Interventions
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HCP1303 capsule 5/0.2mg
HCP1303 capsule 5/0.4mg
HGP1201
HCP1303 capsule 5/0.2mg placebo
HCP1303 capsule 5/0.4mg placebo
HGP1201 placebo
Eligibility Criteria
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Inclusion Criteria
1. ≥50 age
2. BPH(Benign Prostatic Hyperplasia) + Total IPSS(International Prostate Symptom Score) ≥ 13
3. Abnormal Erectile function ≥ at least 3months based on screening date
* At Visit 2 1. Total IPSS ≥ 13
Exclusion Criteria
2. History of allergy for Sulfonamide
3. PSA (Prostate Specific Antigen) ≥4ng/mL
50 Years
MALE
No
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Se Woong Kim, M.D.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Catholic University of Seoul St.Mary's Hospital
Other Identifiers
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HM-TASU-301
Identifier Type: -
Identifier Source: org_study_id
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