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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02667938

Enrollment

510

Registered

2016-01-29

Start date

2015-03-31

Completion date

2016-05-31

Last updated

2016-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia

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

Interventions

DRUGHCP1303 capsule 5/0.2mg

DRUGHCP1303 capsule 5/0.4mg

DRUGHGP1201

DRUGHCP1303 capsule 5/0.2mg placebo

DRUGHCP1303 capsule 5/0.4mg placebo

DRUGHGP1201 placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change of Total IPSS (International Prostate Symptom Score)	baseline and 12 weeks

Secondary

Measure	Time frame
Change of Total IPSS	baseline and 4weeks, 8sweeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026