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

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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