Benign Prostate HyperplasiaPhase 3NCT02390882
A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HGP0412 and HIP1402 in Patients With BPH
A Phase 3 study testing HGP0412 capsule and HIP1402 capsule in people with Benign Prostate Hyperplasia, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Benign Prostate Hyperplasia
- What is being tested?
- HGP0412 capsule and HIP1402 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 494 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2014to Jul 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age>=45, male, diagnosed on BPH, Total IPSS>=13
Who cannot join
- Hypersensitivity to investigational products or components
- PSA>=4ng/ml
Trial locations and contacts
1 site in 1 country.
About this study
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
The main objective of this study is to evaluate efficacy and safety of (Tamsulosin) HGP0412 and HIP1402 in patients with Benign Prostatic Hyperplasia
Read the detailed 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
- Conditions
- Benign Prostate Hyperplasia
- Being tested
- Placebo, HGP0412 capsule, HIP1402 capsule
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Tamsulosin Placebo
Placebo
HGP0412 capsuleDrug
Also called Tamsulosin HCl 0.2mg
Tamsulon high dose
HIP1402 capsuleDrug
Also called Tamsulosin HCl 0.4mg
Tamsulon high dose
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Tamsulosin placebo (12 weeks) Receives: Drug: Placebo |
| Treatment 1 | Experimental | HGP0412 capsule (12 weeks) Receives: Drug: HGP0412 capsule |
| Treatment2 | Experimental | HIP1402 capsule (12 weeks) Receives: Drug: HIP1402 capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total International Prostate Symptom Score
Measured: 12 weeks
Secondary outcomes (1)
Total International Prostate Symptom Score
Measured: 4, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startOct 2014
- Primary completionMay 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Prostate HyperplasiaStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lee, MD, Principal investigator, Hanyang University Guri Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390882
- Sponsor's protocol ID
- HM-VICT-301
- Status last verified
- Oct 2016
- First submitted
- 23 Feb 2015
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29490509
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02390882
- Acronym / sponsor ID
- HM-VICT-301
- Conditions
- Benign Prostate Hyperplasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to evaluate efficacy and safety of (Tamsulosin) HGP0412 and HIP1402 in patients with Benign Prostatic Hyperplasia
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboTamsulosin placebo (12 weeks) |
| Treatment 1 | Experimental | Drug: HGP0412 capsuleHGP0412 capsule (12 weeks) |
| Treatment2 | Experimental | Drug: HIP1402 capsuleHIP1402 capsule (12 weeks) |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age>=45, male, diagnosed on BPH, Total IPSS>=13
Key exclusion criteria (2 listed)
- Hypersensitivity to investigational products or components
- PSA>=4ng/ml
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: Tamsulosin PlaceboPlacebo | Drug | Placebo |
| HGP0412 capsuleAlso: Tamsulosin HCl 0.2mgTamsulon high dose | Drug | Treatment 1 |
| HIP1402 capsuleAlso: Tamsulosin HCl 0.4mgTamsulon high dose | Drug | Treatment2 |
Primary outcome
Total International Prostate Symptom Score
Time frame: 12 weeks
1 secondary outcome
Total International Prostate Symptom Score
Time frame: 4, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- Derived from this study: PubMed 29490509Chung 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee, MD principal investigator
Hanyang University Guri Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HGP0412 capsule and HIP1402 capsule in people with Benign Prostate Hyperplasia, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total International Prostate Symptom Score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02390882, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2016.