MedDataX Logo

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

NCT ID: NCT02390882

Last Updated: 2016-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

494 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of Tamsulosin/Solifenacin Combination Therapy in Patients With Voiding Symptoms and Moderate to Severe Storage Symptoms Due to Benign Prostate Hyperplasia

NCT02827578

Benign Prostate Hyperplasia
UNKNOWN PHASE3

Study to Compare the Efficacy and Safety of Combination Treatment With Dutasteride and Tamsulosin With Tamsulosin Monotherapy, in Men With Moderate to Severe Benign Prostatic Hyperplasia

NCT02058368

Prostatic Hyperplasia
COMPLETED PHASE3

Clinical Trial to Compare the Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for LUTS Due to BPH

NCT02972268

Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia
COMPLETED PHASE3

Study to Investigate the Efficacy and Safety of GL2702 GLARS-NF1tablet and Harnal-D - Tablet in BPH Patients With LUTS

NCT02303769

Benign Prostatic Hyperplasia
COMPLETED PHASE3

An Observational Study of Tamsulosin in Patients With Benign Prostatic Hyperplasia

NCT05422677

BPH Benign Prostatic Hyperplasia
COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Benign Prostate Hyperplasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Tamsulosin placebo (12 weeks)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Treatment 1

HGP0412 capsule (12 weeks)

Group Type EXPERIMENTAL

HGP0412 capsule

Intervention Type DRUG

Tamsulon high dose

Treatment2

HIP1402 capsule (12 weeks)

Group Type EXPERIMENTAL

HIP1402 capsule

Intervention Type DRUG

Tamsulon high dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

Placebo

Intervention Type DRUG

HGP0412 capsule

Tamsulon high dose

Intervention Type DRUG

HIP1402 capsule

Tamsulon high dose

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tamsulosin Placebo Tamsulosin HCl 0.2mg Tamsulosin HCl 0.4mg

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Hypersensitivity to investigational products or components
* PSA\>=4ng/ml
Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Hanyang University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hanyang University Guri Hospital

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

Chung JH, Oh CY, Kim JH, Ha US, Kim TH, Lee SH, Han JH, Bae JH, Chang IH, Han DH, Yoo TK, Chung JI, Kim SW, Jung J, Kim YI, Lee SW. Efficacy and safety of tamsulosin 0.4 mg single pills for treatment of Asian patients with symptomatic benign prostatic hyperplasia with lower urinary tract symptoms: a randomized, double-blind, phase 3 trial. Curr Med Res Opin. 2018 Oct;34(10):1793-1801. doi: 10.1080/03007995.2018.1447451. Epub 2018 Apr 12.

Reference Type DERIVED
PMID: 29490509 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HM-VICT-301

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PK Comparison of GL2701 With Finasteride and Tamsulosin in Combination
NCT01829893 COMPLETED PHASE1
Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic Benign Prostatic Hyperplasia (BPH)
NCT01404637 UNKNOWN NA
Pilot Study Investigating Safety and Efficacy of Tadalafil as Treatment for Benign Prostatic Hyperplasia (BPH) in Asian Men
NCT00540124 COMPLETED PHASE2
The Efficacy and Safety of the Combination of Tamsulosin and Tadalafil in Men With Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia and Erectile Dysfunction
NCT02862483 UNKNOWN PHASE3
Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment
NCT00090103 COMPLETED PHASE3
Clinical Effect and Safety of Tamsulosin 0.4mg in Patients With LUTS/BPH Refractory to Tamsulosin 0.2mg
NCT00954889 UNKNOWN NA
Safety and Efficacy of 0.5mg Dutasteride and 0.4mg Tamsulosin Combination Once Daily for Six Months for Benign Prostatic Hyperplasia
NCT01673490 TERMINATED PHASE4
A Study To Compare 3 Different Formulations Of Tamsulosin At Steady State.
NCT00609596 COMPLETED PHASE1
Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients
NCT03246880 COMPLETED PHASE3
Study to Evaluate the Therapeutic Action of Tamsulosin and Finasteride in Symptomatic Benign Prostatic Hyperplasia (BPH) Patients
NCT02244229 COMPLETED PHASE4
Comparison of Finasteride and Tamsulosin for Treatment of Benign Prostatic Hyperplasia (BPH) (MK-0906A-149 AM2)
NCT01534351 TERMINATED PHASE3
Efficacy and Safety of Tadalafil, Tamsulosin, and Their Combinations in Treating Lower Urinary Tract Symptoms in BPH Patients with Prostate Volumes ≤ 40 Ml: a Prospective Comparative Study
NCT06809205 COMPLETED PHASE4
Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia
NCT00701779 COMPLETED PHASE4
A Study of Tadalafil in Men With Benign Prostatic Hyperplasia
NCT00970632 COMPLETED PHASE3
A Phase III Clinical Study of H077 Sustained-Release Tablets Compared With Silodosin Capsules in the Treatment of Benign Prostatic Hyperplasia
NCT07146386 NOT_YET_RECRUITING PHASE3
Composite Steep-pulseTreatment Device Used in Patients With Benign Prostatic Hyperplasia
NCT05531344 COMPLETED PHASE2/PHASE3
Evaluate the Efficacy and Safety of GV1001 in Patients With Benign Prostatic Hyperplasia (BPH)
NCT04032067 COMPLETED PHASE3
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Patients With BPH
NCT02855892 COMPLETED PHASE2
Comparative Efficacy of Dutasteride Plus Tamulosin With Lifestyle Advice Versus Watchful Waiting Plus Lifestyle Advice in the Management of Treatment naïve Men With Moderately Symptomatic Benign Prostatic Hyperplasia and Prostate Enlargement
NCT01294592 COMPLETED PHASE4
A Study Assessing a Range of Formulations of the Fixed Dose Combination Product Containing Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) to Find a Formulation Which is Bioequivalent to Harnal-D Tablets (Tamsulosin Hydrochloride, 0.2mg) in Healthy Male Subjects From North East Asia
NCT01495026 COMPLETED PHASE1
Efficacy and Safety of the DTT106 in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia
NCT06264414 NOT_YET_RECRUITING PHASE3
This Will be an Open-label, Three-period, Fixed-sequence Study to Evaluate the Drug-drug Interaction, Pharmacokinetics and Safety of Dutasteride and Tamsulosin When Administered Alone and In-combination in Chinese Healthy Male Volunteers. The Study Will Last Approximately Eleven Weeks. Blood Samples
NCT01957189 COMPLETED PHASE1
Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fed Male.
NCT02417844 COMPLETED PHASE1
Advanced Benefits of Alpha-blocker Monotherapy on Lower Urinary Tracts Symptoms(LUTS) Patients
NCT01736033 UNKNOWN PHASE4
A Study to Determine the Bioavailability of a Fixed Dose Combination Product of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) Relative to Co-administration of the Individual Components in Healthy Male Subjects of North East Asian and Non-Asian Ancestry.
NCT01254071 COMPLETED PHASE1