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

October 12, 2016 updated by: Hanmi Pharmaceutical Company Limited

A Multicenter, Randomized, Double-blind, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HCP1303 Capsules

The main objective of this study is to evaluate efficacy and safety of HCP1301 capsule in patients with Benign Prostatic Hyperplasia and Erectile Dysfunction

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A multicenter, randomized, double-blind, phase 3 clinical trial to evaluate the efficacy and safety of HCP1303 capsule

Study Type

Interventional

Enrollment (Actual)

510

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment 1
HCP1303 capsule 5/0.2mg + HCP1303 capsule 5/0.4mg placebo+ HGP1201 placebo
Drug: HCP1303 capsule 5/0.2mg
Drug: HCP1303 capsule 5/0.4mg placebo
Drug: HGP1201 placebo
Experimental: Treatment 2
HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg + HGP1201 placebo
Drug: HGP1201 placebo
Drug: HCP1303 capsule 5/0.4mg
Drug: HCP1303 capsule 5/0.2mg placebo
Active Comparator: Active Comparator
HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg placebo+ HGP1201
Drug: HGP1201
Drug: HCP1303 capsule 5/0.4mg placebo
Drug: HCP1303 capsule 5/0.2mg placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of Total IPSS (International Prostate Symptom Score)
Time Frame: baseline and 12 weeks
baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of Total IPSS
Time Frame: baseline and 4weeks, 8sweeks
baseline and 4weeks, 8sweeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Investigators

  • Principal Investigator: Se Woong Kim, M.D.,Ph.D., Catholic University of Seoul St.Mary's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

January 26, 2016

First Submitted That Met QC Criteria

January 26, 2016

First Posted (Estimate)

January 29, 2016

Study Record Updates

Last Update Posted (Estimate)

October 13, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-TASU-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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