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NCT02667938 Clinical Trial

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

Benign Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02667938
Other study ID # HM-TASU-301
Secondary ID
Status Completed
Phase Phase 3
First received January 26, 2016
Last updated October 12, 2016
Start date March 2015
Est. completion date May 2016

Study information
Verified date October 2016
Source Hanmi Pharmaceutical Company Limited
Contact n/a
Is FDA regulated No
Health authority South Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 510
Est. completion date May 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Male
Age group 50 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• HCP1303 capsule 5/0.2mg

• HCP1303 capsule 5/0.4mg

• HGP1201

• HCP1303 capsule 5/0.2mg placebo

• HCP1303 capsule 5/0.4mg placebo

• HGP1201 placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hanmi Pharmaceutical Company Limited

Outcome
Type Measure Description Time frame Safety issue
Primary Change of Total IPSS (International Prostate Symptom Score) baseline and 12 weeks No
Secondary Change of Total IPSS baseline and 4weeks, 8sweeks No
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