Erectile DysfunctionPhase 3NCT02587988
Trial to Evaluate the Efficacy and Safety of HCP1302
A Phase 3 study testing HCP1302 and HGP0904 in people with Erectile Dysfunction and Hypertension, run by Hanmi Pharmaceutical Company Limited.
Trial summary
Trial to Evaluate the Efficacy and Safety of HCP1302 Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Erectile Dysfunction, Hypertension
- What is being tested?
- HCP1302 and HGP0904
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 232 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Aug 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 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- History of hypersensitivity to Amlodipine or Tadalafil
- Has a severe liver disorder(Child-Pugh Class C) or liver enzyme (AST, ALT) level exceeds 3 times more than normal upper range
- Has a clinically significant renal failure (Scr > 2mg/dl)
- Uncontrolled diabetes mellitus (HbA1C >12%)
- At screening date, blood pressure gap of selected arms is sitSBP ≥20mmHg or sitDBP ≥10mmHg
- Taking PDE-5 inhibitors or other therapeutic agents for Erectile Dysfunction within 7 days based on screening date
- No reaction to PDE-5 inhibitors
About this study
Official title: A Randomized, Double-blind, Multicenter, Phase Ⅲ Study to Evaluate the Efficacy and Safety of HCP1302 in Both Erectile Dysfunction and Hypertension Patients Being Treated With HGP0904
Trial to Evaluate the Efficacy and Safety of HCP1302
Read the detailed description
A Randomized, Double-blind, Multicenter, Phase Ⅲ study to Evaluate the Efficacy and Safety of HCP1302 in Both Erectile Dysfunction and Hypertension Patients being Treated with HGP0904
- Conditions
- Erectile Dysfunction, Hypertension
- Being tested
- HCP1302, HGP0904, Placebo (for HCP1302), Placebo (for HGP0904)
- Keywords
- Erectile dysfunction & Hypertension
- Medical subject headings
- Erectile Dysfunction, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCP1302Drug
HGP0904Drug
Placebo (for HCP1302)Drug
Placebo (for HGP0904)Drug
| Study group | Role | What they receive |
|---|---|---|
| HCP1302+HGP0904Placebo | Experimental | HCP1302+HGP0904Placebo for 12weeks Receives: Drug: HCP1302; Drug: Placebo (for HGP0904) |
| HCP1302Placebo+HGP0904 | Active comparator | HCP1302Placebo+HGP0904 for 12weeks Receives: Drug: HGP0904; Drug: Placebo (for HCP1302) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of IIEF-EF domain score
Measured: baseline and 12 weeks
Change of sitting diastolic blood pressure
Measured: baseline and 12 weeks
Secondary outcomes (3)
Change of sitting diastolic blood pressure
Measured: baseline, 4weeks and 8weeks
Change of sitting systolic blood pressure
Measured: baseline,4weeks, 8weeks and 12 weeks
Change of IIEF-EF domain score
Measured: baseline, 4weeks and 8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startSep 2014
- Primary completionMay 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies 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
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587988
- Sponsor's protocol ID
- HM-TARO-301
- Status last verified
- Oct 2016
- First submitted
- 25 Oct 2015
- Last updated
- 1 Nov 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 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter, Phase Ⅲ Study to Evaluate the Efficacy and Safety of HCP1302 in Both Erectile Dysfunction and Hypertension Patients Being Treated With HGP0904
- ClinicalTrials.gov ID
- NCT02587988
- Acronym / sponsor ID
- HM-TARO-301
- Conditions
- Erectile Dysfunction, Hypertension
- Keywords
- Erectile dysfunction & Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 27 Oct 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.
Trial to Evaluate the Efficacy and Safety of HCP1302
Detailed description
A Randomized, Double-blind, Multicenter, Phase Ⅲ study to Evaluate the Efficacy and Safety of HCP1302 in Both Erectile Dysfunction and Hypertension Patients being Treated with HGP0904
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCP1302+HGP0904Placebo | Experimental | Drug: HCP1302, Drug: Placebo (for HGP0904)HCP1302+HGP0904Placebo for 12weeks |
| HCP1302Placebo+HGP0904 | Active comparator | Drug: HGP0904, Drug: Placebo (for HCP1302)HCP1302Placebo+HGP0904 for 12weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- History of hypersensitivity to Amlodipine or Tadalafil
- Has a severe liver disorder(Child-Pugh Class C) or liver enzyme (AST, ALT) level exceeds 3 times more than normal upper range
- Has a clinically significant renal failure (Scr > 2mg/dl)
- Uncontrolled diabetes mellitus (HbA1C >12%)
- At screening date, blood pressure gap of selected arms is sitSBP ≥20mmHg or sitDBP ≥10mmHg
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 |
|---|---|---|
| HCP1302 | Drug | HCP1302+HGP0904Placebo |
| HGP0904 | Drug | HCP1302Placebo+HGP0904 |
| Placebo (for HCP1302) | Drug | HCP1302Placebo+HGP0904 |
| Placebo (for HGP0904) | Drug | HCP1302+HGP0904Placebo |
Primary outcome
Change of IIEF-EF domain score
Time frame: baseline and 12 weeks
Change of sitting diastolic blood pressure
Time frame: baseline and 12 weeks
3 secondary outcomes
Change of sitting diastolic blood pressure
Time frame: baseline, 4weeks and 8weeks
Change of sitting systolic blood pressure
Time frame: baseline,4weeks, 8weeks and 12 weeks
Change of IIEF-EF domain score
Time frame: baseline, 4weeks and 8weeks
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 1 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HCP1302 and HGP0904 in people with Erectile Dysfunction and Hypertension, 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 0 inclusion and 7 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 1 Nov 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 IIEF-EF domain score (time frame: baseline and 12 weeks). The study lists 2 primary outcomes in all. 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 1 Nov 2016.