NCT02667938

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
510

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

10 months

First QC Date

January 26, 2016

Last Update Submit

October 12, 2016

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • Change of Total IPSS (International Prostate Symptom Score)

    baseline and 12 weeks

Secondary Outcomes (1)

  • Change of Total IPSS

    baseline and 4weeks, 8sweeks

Study Arms (3)

Treatment 1

EXPERIMENTAL

HCP1303 capsule 5/0.2mg + HCP1303 capsule 5/0.4mg placebo+ HGP1201 placebo

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

Treatment 2

EXPERIMENTAL

HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg + HGP1201 placebo

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

Active Comparator

ACTIVE COMPARATOR

HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg placebo+ HGP1201

Drug: HGP1201Drug: HCP1303 capsule 5/0.2mg placeboDrug: HCP1303 capsule 5/0.4mg placebo

Interventions

HCP1303 capsule 5/0.2mgDRUG
Treatment 1
HCP1303 capsule 5/0.4mgDRUG
Treatment 2
HGP1201DRUG
Active Comparator
HCP1303 capsule 5/0.2mg placeboDRUG
Active ComparatorTreatment 2
HCP1303 capsule 5/0.4mg placeboDRUG
Active ComparatorTreatment 1
HGP1201 placeboDRUG
Treatment 1Treatment 2

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Se Woong Kim, M.D.,Ph.D.

    Catholic University of Seoul St.Mary's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2016

First Posted

January 29, 2016

Study Start

March 1, 2015

Primary Completion

January 1, 2016

Study Completion

May 1, 2016

Last Updated

October 13, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share