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A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HCP1303 Capsules

Primary Purpose

Benign Prostatic Hyperplasia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
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
Sponsored by
Hanmi Pharmaceutical Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • At Visit 1

    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:

  1. History of hypersensitivity to Tamsulosin or Tadalafil
  2. History of allergy for Sulfonamide
  3. PSA (Prostate Specific Antigen) ≥4ng/mL

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Treatment 1

    Treatment 2

    Active Comparator

    Arm Description

    HCP1303 capsule 5/0.2mg + HCP1303 capsule 5/0.4mg placebo+ HGP1201 placebo

    HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg + HGP1201 placebo

    HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg placebo+ HGP1201

    Outcomes

    Primary Outcome Measures

    Change of Total IPSS (International Prostate Symptom Score)

    Secondary Outcome Measures

    Change of Total IPSS

    Full Information

    First Posted
    January 26, 2016
    Last Updated
    October 12, 2016
    Sponsor
    Hanmi Pharmaceutical Company Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02667938
    Brief Title
    A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HCP1303 Capsules
    Official Title
    A Multicenter, Randomized, Double-blind, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HCP1303 Capsules
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hanmi Pharmaceutical Company Limited

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The main objective of this study is to evaluate efficacy and safety of HCP1301 capsule in patients with Benign Prostatic Hyperplasia and Erectile Dysfunction
    Detailed Description
    A multicenter, randomized, double-blind, phase 3 clinical trial to evaluate the efficacy and safety of HCP1303 capsule

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Benign Prostatic Hyperplasia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    510 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment 1
    Arm Type
    Experimental
    Arm Description
    HCP1303 capsule 5/0.2mg + HCP1303 capsule 5/0.4mg placebo+ HGP1201 placebo
    Arm Title
    Treatment 2
    Arm Type
    Experimental
    Arm Description
    HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg + HGP1201 placebo
    Arm Title
    Active Comparator
    Arm Type
    Active Comparator
    Arm Description
    HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg placebo+ HGP1201
    Intervention Type
    Drug
    Intervention Name(s)
    HCP1303 capsule 5/0.2mg
    Intervention Type
    Drug
    Intervention Name(s)
    HCP1303 capsule 5/0.4mg
    Intervention Type
    Drug
    Intervention Name(s)
    HGP1201
    Intervention Type
    Drug
    Intervention Name(s)
    HCP1303 capsule 5/0.2mg placebo
    Intervention Type
    Drug
    Intervention Name(s)
    HCP1303 capsule 5/0.4mg placebo
    Intervention Type
    Drug
    Intervention Name(s)
    HGP1201 placebo
    Primary Outcome Measure Information:
    Title
    Change of Total IPSS (International Prostate Symptom Score)
    Time Frame
    baseline and 12 weeks
    Secondary Outcome Measure Information:
    Title
    Change of Total IPSS
    Time Frame
    baseline and 4weeks, 8sweeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: At Visit 1 ≥50 age BPH(Benign Prostatic Hyperplasia) + Total IPSS(International Prostate Symptom Score) ≥ 13 Abnormal Erectile function ≥ at least 3months based on screening date At Visit 2 1. Total IPSS ≥ 13 Exclusion Criteria: History of hypersensitivity to Tamsulosin or Tadalafil History of allergy for Sulfonamide PSA (Prostate Specific Antigen) ≥4ng/mL
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Se Woong Kim, M.D.,Ph.D.
    Organizational Affiliation
    Catholic University of Seoul St.Mary's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HCP1303 Capsules

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