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Completed

NCT Number: NCT02667938

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

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

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At Visit 1
  • ≥50 age
  • BPH(Benign Prostatic Hyperplasia) + Total IPSS(International Prostate Symptom Score) ≥ 13
  • Abnormal Erectile function ≥ at least 3months based on screening date
  • At Visit 2 1. Total IPSS ≥ 13

Exclusion criteria

  • History of hypersensitivity to Tamsulosin or Tadalafil
  • History of allergy for Sulfonamide
  • PSA (Prostate Specific Antigen) ≥4ng/mL

Treatment and study plan

HCP1303 capsule 5/0.2mg

Drug

HCP1303 capsule 5/0.4mg

Drug

HGP1201

Drug

HCP1303 capsule 5/0.2mg placebo

Drug

HCP1303 capsule 5/0.4mg placebo

Drug

HGP1201 placebo

Drug

Primary outcomes

  1. Change of Total IPSS (International Prostate Symptom Score)

    Time frame: baseline and 12 weeks

Secondary outcomes

  1. Change of Total IPSS

    Time frame: baseline and 4weeks, 8sweeks

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 29, 2016
Registry last updated
Oct 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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