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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Benign Prostate Hyperplasia

Treatments: Drug: Placebo; Drug: HIP1402 capsule; Drug: HGP0412 capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT02390882

HM-VICT-301

Details and patient eligibility

About

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

Full 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

Enrollment: 494 patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Hypersensitivity to investigational products or components
• PSA>=4ng/ml

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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494 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Tamsulosin placebo (12 weeks)

Treatment:

Drug: Placebo

Treatment 1

Experimental group

Description:

HGP0412 capsule (12 weeks)

Treatment:

Drug: HGP0412 capsule

Treatment2

Experimental group

Description:

HIP1402 capsule (12 weeks)

Treatment:

Drug: HIP1402 capsule