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NCT02390882 Clinical Trial

A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HGP0412 and HIP1402 in Patients With BPH

Benign Prostate Hyperplasia Clinical Trial

Official title:
A Multicenter, Randomized, Double-blind, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HGP0412 and HIP1402 in Patients With Benign Prostatic Hyperplasia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02390882
Other study ID # HM-VICT-301
Secondary ID
Status Completed
Phase Phase 3
First received February 23, 2015
Last updated October 12, 2016
Start date October 2014
Est. completion date July 2015

Study information
Verified date October 2016
Source Hanmi Pharmaceutical Company Limited
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial Summary

The main objective of this study is to evaluate efficacy and safety of (Tamsulosin) HGP0412 and HIP1402 in patients with Benign Prostatic Hyperplasia

Description:

A multicenter, randomized, double-blind, phase 3 clinical trial to evaluate the efficacy and safety of (Tamsulosin) HGP0412 and HIP1402 in patients with benign prostatic hyperplasia

Recruitment information / eligibility
Status Completed
Enrollment 494
Est. completion date July 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Male
Age group 45 Years and older
Eligibility Inclusion Criteria:

- age>=45, male, diagnosed on BPH, Total IPSS>=13

Exclusion Criteria:

- Hypersensitivity to investigational products or components

- PSA>=4ng/ml

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Placebo
• HGP0412 capsule
Tamsulon high dose
• HIP1402 capsule
Tamsulon high dose

Locations
Country Name City State
Korea, Republic of Hanyang University Guri Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Total International Prostate Symptom Score 12 weeks No
Secondary Total International Prostate Symptom Score 4, 8 weeks No
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