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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Benign Prostatic Hyperplasia

Treatments: Drug: HCP1303 capsule 5/0.2mg placebo; Drug: HGP1201 placebo; Drug: HGP1201; Drug: HCP1303 capsule 5/0.4mg placebo; Drug: HCP1303 capsule 5/0.4mg; Drug: HCP1303 capsule 5/0.2mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02667938

HM-TASU-301

Details and patient eligibility

About

The main objective of this study is to evaluate efficacy and safety of HCP1301 capsule in patients with Benign Prostatic Hyperplasia and Erectile Dysfunction

Full description

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

Enrollment: 510 patients

Sex: Male

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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510 participants in 3 patient groups

Treatment 1

Experimental group

Description:

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

Treatment:

Drug: HGP1201 placebo

Drug: HCP1303 capsule 5/0.4mg placebo

Drug: HCP1303 capsule 5/0.2mg

Treatment 2

Experimental group

Description:

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

Treatment:

Drug: HGP1201 placebo

Drug: HCP1303 capsule 5/0.4mg

Drug: HCP1303 capsule 5/0.2mg placebo

Active Comparator

Active Comparator group

Description:

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

Treatment:

Drug: HCP1303 capsule 5/0.4mg placebo

Drug: HGP1201

Drug: HCP1303 capsule 5/0.2mg placebo