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

Phase 3

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Drug: HCP1303 capsule 5/0.2mg; Drug: HCP1303 capsule 5/0.4mg; Drug: HGP1201; Drug: HCP1303 capsule 5/0.4mg placebo; Drug: HCP1303 capsule 5/0.2mg placebo; Drug: HGP1201 placebo

• Registration Number: NCT02667938
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2016-01
• Study First Submitted: 2016-01-26
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-29
• Study Completion: 2016-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 510

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment 1	HCP1303 capsule 5/0.2mg	HCP1303 capsule 5/0.2mg + HCP1303 capsule 5/0.4mg placebo+ HGP1201 placebo
Treatment 1	HCP1303 capsule 5/0.4mg placebo	HCP1303 capsule 5/0.2mg + HCP1303 capsule 5/0.4mg placebo+ HGP1201 placebo
Treatment 1	HGP1201 placebo	HCP1303 capsule 5/0.2mg + HCP1303 capsule 5/0.4mg placebo+ HGP1201 placebo
Treatment 2	HCP1303 capsule 5/0.4mg	HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg + HGP1201 placebo
Treatment 2	HCP1303 capsule 5/0.2mg placebo	HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg + HGP1201 placebo
Treatment 2	HGP1201 placebo	HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg + HGP1201 placebo
Active Comparator	HCP1303 capsule 5/0.2mg placebo	HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg placebo+ HGP1201
Active Comparator	HCP1303 capsule 5/0.4mg placebo	HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg placebo+ HGP1201
Active Comparator	HGP1201	HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg placebo+ HGP1201

Primary Outcome Measures

Name	Time	Method
Change of Total IPSS (International Prostate Symptom Score)	baseline and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Change of Total IPSS	baseline and 4weeks, 8sweeks