A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HGP0412 and HIP1402 in Patients With BPH

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 HGP0412 and HIP1402 in Patients With Benign Prostatic Hyperplasia

The main objective of this study is to evaluate efficacy and safety of (Tamsulosin) HGP0412 and HIP1402 in patients with Benign Prostatic Hyperplasia

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 (Tamsulosin) HGP0412 and HIP1402 in patients with benign prostatic hyperplasia

Study Type

Interventional

Enrollment (Actual)

494

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • age>=45, male, diagnosed on BPH, Total IPSS>=13

Exclusion Criteria:

  • Hypersensitivity to investigational products or components
  • PSA>=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
Placebo Comparator: Placebo
Tamsulosin placebo (12 weeks)
Drug: Placebo
Placebo
Other Names:
  • Tamsulosin Placebo
Experimental: Treatment 1
HGP0412 capsule (12 weeks)
Drug: HGP0412 capsule
Tamsulon high dose
Other Names:
  • Tamsulosin HCl 0.2mg
Experimental: Treatment2
HIP1402 capsule (12 weeks)
Drug: HIP1402 capsule
Tamsulon high dose
Other Names:
  • Tamsulosin HCl 0.4mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total International Prostate Symptom Score
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Total International Prostate Symptom Score
Time Frame: 4, 8 weeks
4, 8 weeks

Collaborators and Investigators

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

Sponsor

Hanmi Pharmaceutical Company Limited

Investigators

  • Principal Investigator: Lee, MD, Hanyang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

February 23, 2015

First Submitted That Met QC Criteria

March 17, 2015

First Posted (Estimate)

March 18, 2015

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-VICT-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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