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

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

Sponsors

Lead Sponsor: Hanmi Pharmaceutical Company Limited

Source 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

Overall Status Completed
Start Date 2015-03-01
Completion Date 2016-05-01
Primary Completion Date 2016-01-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change of Total IPSS (International Prostate Symptom Score) baseline and 12 weeks
Secondary Outcome
Measure Time Frame
Change of Total IPSS baseline and 4weeks, 8sweeks
Enrollment 510
Condition
Intervention

Intervention Type: Drug

Intervention Name: HCP1303 capsule 5/0.2mg

Arm Group Label: Treatment 1

Intervention Type: Drug

Intervention Name: HCP1303 capsule 5/0.4mg

Arm Group Label: Treatment 2

Intervention Type: Drug

Intervention Name: HGP1201

Arm Group Label: Active Comparator

Intervention Type: Drug

Intervention Name: HCP1303 capsule 5/0.2mg placebo

Intervention Type: Drug

Intervention Name: HCP1303 capsule 5/0.4mg placebo

Intervention Type: Drug

Intervention Name: HGP1201 placebo

Eligibility

Criteria:

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

Gender:

Male

Minimum Age:

50 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Se Woong Kim, M.D.,Ph.D. Principal Investigator Catholic University of Seoul St.Mary's Hospital
Verification Date

2016-10-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Treatment 1

Type: Experimental

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

Label: Treatment 2

Type: Experimental

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

Label: Active Comparator

Type: Active Comparator

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

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 [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News