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

Phase 3

Completed

• Conditions: Benign Prostate Hyperplasia
• Interventions: Drug: Placebo; Drug: HIP1402 capsule; Drug: HGP0412 capsule

• Registration Number: NCT02390882
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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

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 Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-02-23
• Study First Submitted QC: 2015-03-17
• Study First Posted: 2015-03-18
• Primary Completion: 2015-05
• Study Completion: 2015-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 494

Inclusion Criteria

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

Exclusion Criteria

• Hypersensitivity to investigational products or components
• PSA>=4ng/ml

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Tamsulosin placebo (12 weeks)
Treatment2	HIP1402 capsule	HIP1402 capsule (12 weeks)
Treatment 1	HGP0412 capsule	HGP0412 capsule (12 weeks)

Primary Outcome Measures

Name	Time	Method
Total International Prostate Symptom Score	12 weeks

Secondary Outcome Measures

Name	Time	Method
Total International Prostate Symptom Score	4, 8 weeks

Trial Locations

Locations (1)

Hanyang University Guri Hospital; 🇰🇷 Seoul, Korea, Republic of