Benign Prostatic HyperplasiaPhase 3NCT02667938
A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HCP1303 Capsules
A Phase 3 study testing HCP1303 capsule 5/0.2mg, HCP1303 capsule 5/0.4mg and HGP1201 in people with Benign Prostatic Hyperplasia, run by Hanmi Pharmaceutical Company Limited.
Trial 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 Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- HCP1303 capsule 5/0.2mg, HCP1303 capsule 5/0.4mg and HGP1201
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 510 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to May 2016
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of hypersensitivity to Tamsulosin or Tadalafil
- History of allergy for Sulfonamide
- PSA (Prostate Specific Antigen) ≥4ng/mL
About this study
Official title: A Multicenter, Randomized, Double-blind, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HCP1303 Capsules
The main objective of this study is to evaluate efficacy and safety of HCP1301 capsule in patients with Benign Prostatic Hyperplasia and Erectile Dysfunction
Read the detailed description
A multicenter, randomized, double-blind, phase 3 clinical trial to evaluate the efficacy and safety of HCP1303 capsule
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- HCP1303 capsule 5/0.2mg, HCP1303 capsule 5/0.4mg, HGP1201, HCP1303 capsule 5/0.2mg placebo, HCP1303 capsule 5/0.4mg placebo
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCP1303 capsule 5/0.2mgDrug
HCP1303 capsule 5/0.4mgDrug
HGP1201Drug
HCP1303 capsule 5/0.2mg placeboDrug
HCP1303 capsule 5/0.4mg placeboDrug
HGP1201 placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Experimental | HCP1303 capsule 5/0.2mg + HCP1303 capsule 5/0.4mg placebo+ HGP1201 placebo Receives: Drug: HCP1303 capsule 5/0.2mg; Drug: HCP1303 capsule 5/0.4mg placebo; Drug: HGP1201 placebo |
| Treatment 2 | Experimental | HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg + HGP1201 placebo Receives: Drug: HCP1303 capsule 5/0.4mg; Drug: HCP1303 capsule 5/0.2mg placebo; Drug: HGP1201 placebo |
| Active Comparator | Active comparator | HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg placebo+ HGP1201 Receives: Drug: HGP1201; Drug: HCP1303 capsule 5/0.2mg placebo; Drug: HCP1303 capsule 5/0.4mg placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Total IPSS (International Prostate Symptom Score)
Measured: baseline and 12 weeks
Secondary outcomes (1)
Change of Total IPSS
Measured: baseline and 4weeks, 8sweeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startMar 2015
- Primary completionJan 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic 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
- 510 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Se Woong Kim, M.D.,Ph.D., Principal investigator, Catholic University of Seoul St.Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667938
- Sponsor's protocol ID
- HM-TASU-301
- Status last verified
- Oct 2016
- First submitted
- 26 Jan 2016
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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 HCP1303 Capsules
- ClinicalTrials.gov ID
- NCT02667938
- Acronym / sponsor ID
- HM-TASU-301
- Conditions
- Benign Prostatic Hyperplasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 510 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 29 Jan 2016 (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 HCP1301 capsule in patients with Benign Prostatic Hyperplasia and Erectile Dysfunction
Detailed description
A multicenter, randomized, double-blind, phase 3 clinical trial to evaluate the efficacy and safety of HCP1303 capsule
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Experimental | Drug: HCP1303 capsule 5/0.2mg, Drug: HCP1303 capsule 5/0.4mg placebo, Drug: HGP1201 placeboHCP1303 capsule 5/0.2mg + HCP1303 capsule 5/0.4mg placebo+ HGP1201 placebo |
| Treatment 2 | Experimental | Drug: HCP1303 capsule 5/0.4mg, Drug: HCP1303 capsule 5/0.2mg placebo, Drug: HGP1201 placeboHCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg + HGP1201 placebo |
| Active Comparator | Active comparator | Drug: HGP1201, Drug: HCP1303 capsule 5/0.2mg placebo, Drug: HCP1303 capsule 5/0.4mg placeboHCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg placebo+ HGP1201 |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At Visit 1
- At Visit 2 1. Total IPSS ≥ 13
Key exclusion criteria (3 listed)
- History of hypersensitivity to Tamsulosin or Tadalafil
- History of allergy for Sulfonamide
- PSA (Prostate Specific Antigen) ≥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 |
|---|---|---|
| HCP1303 capsule 5/0.2mg | Drug | Treatment 1 |
| HCP1303 capsule 5/0.4mg | Drug | Treatment 2 |
| HGP1201 | Drug | Active Comparator |
| HCP1303 capsule 5/0.2mg placebo | Drug | Active Comparator, Treatment 2 |
| HCP1303 capsule 5/0.4mg placebo | Drug | Active Comparator, Treatment 1 |
| HGP1201 placebo | Drug | Treatment 1, Treatment 2 |
Primary outcome
Change of Total IPSS (International Prostate Symptom Score)
Time frame: baseline and 12 weeks
1 secondary outcome
Change of Total IPSS
Time frame: baseline and 4weeks, 8sweeks
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.
- 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.
Se Woong Kim, M.D.,Ph.D. principal investigator
Catholic University of Seoul St.Mary's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HCP1303 capsule 5/0.2mg, HCP1303 capsule 5/0.4mg and HGP1201 in people with Benign Prostatic Hyperplasia, run by Hanmi Pharmaceutical Company Limited.
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 5 inclusion and 3 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.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Change of Total IPSS (International Prostate Symptom Score) (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.