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

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Hanmi Pharmaceutical

Status and phase

Completed
Phase 3

Conditions

Benign Prostatic Hyperplasia

Treatments

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

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

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 5/0.2mg placebo
Drug: HCP1303 capsule 5/0.4mg
Active Comparator
Active Comparator group
Description:
HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg placebo+ HGP1201
Treatment:
Drug: HGP1201
Drug: HCP1303 capsule 5/0.2mg placebo
Drug: HCP1303 capsule 5/0.4mg placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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