Erectile DysfunctionPhase 3NCT01774864
Efficacy and Safety Study of Udenafil to Treat Erectile Dysfunction
A Phase 3 study testing DA-8159 (Udenafil) in people with Erectile Dysfunction, run by Dong-A Pharmaceutical Co., Ltd..
Trial summary
Study Design : multi-center, double-blind, placebo-controlled, randomized, parallel group, fixed dose design Phase : Phase III Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- DA-8159 (Udenafil)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 349 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to May 2012
- 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 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients aged 20 years or more diagnosed with ED
Who cannot join
- Had uncontrolled blood pressure
- Had hepatic or renal dysfunction
- Was currently under anticancer chemotherapy
- Had a treatments for ED using other PDE-5 inhibitors
About this study
Official title: Phase 3 Study to Evaluate the Efficacy and Safety of Once-a-day Dosing of Udenafil in the Treatment of Erectile Dysfunction
Study Design : multi-center, double-blind, placebo-controlled, randomized,
parallel group, fixed dose design
Phase : Phase III
- Conditions
- Erectile Dysfunction
- Being tested
- DA-8159 (Udenafil), Placebo
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-8159 (Udenafil)Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| DA-8159 dose 1 | Experimental | Udenafil Receives: Drug: DA-8159 (Udenafil) |
| DA-8159 dose 2 | Experimental | Udenafil Receives: Drug: DA-8159 (Udenafil) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
IIEF EF domain score
Measured: 24 weeks
Secondary outcomes (1)
IIEF, IPSS
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startApr 2011
- Primary completionMay 2012
- Study completionMay 2012
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.
- 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
- 349 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- S W Kim, MD, PhD, Principal investigator, the Catholic University of Korea St. Mary's HospitalD G Moon, MD, PhD, Principal investigator, Korea University Guro HospitalJ J Kim, MD, PhD, Principal investigator, Korea University Anam HospitalN C Park, MD, PhD, Principal investigator, Pusan National University HospitalS W Lee, MD, PhD, Principal investigator, Samsung Medical CenterJ S Paick, MD, PhD, Principal investigator, Seoul National University HospitalT Y Ahn, MD, PhD, Principal investigator, Asan Medical CenterK H Moon, MD, PhD, Principal investigator, Yeungnam University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774864
- Sponsor's protocol ID
- DA8159_EDD_III
- Status last verified
- Jan 2013
- First submitted
- 22 Jan 2013
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study to Evaluate the Efficacy and Safety of Once-a-day Dosing of Udenafil in the Treatment of Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT01774864
- Acronym / sponsor ID
- DA8159_EDD_III
- Conditions
- Erectile Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 349 participants (actual)
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 24 Jan 2013 (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.
Study Design : multi-center, double-blind, placebo-controlled, randomized,
parallel group, fixed dose design
Phase : Phase III
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DA-8159 dose 1 | Experimental | Drug: DA-8159 (Udenafil)Udenafil |
| DA-8159 dose 2 | Experimental | Drug: DA-8159 (Udenafil)Udenafil |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male patients aged 20 years or more diagnosed with ED
Key exclusion criteria (4 listed)
- Had uncontrolled blood pressure
- Had hepatic or renal dysfunction
- Was currently under anticancer chemotherapy
- Had a treatments for ED using other PDE-5 inhibitors
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 |
|---|---|---|
| DA-8159 (Udenafil) | Drug | DA-8159 dose 1, DA-8159 dose 2 |
| Placebo | Drug | Placebo |
Primary outcome
IIEF EF domain score
Time frame: 24 weeks
1 secondary outcome
IIEF, IPSS
Time frame: 24 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 24 Jan 2013.
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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.
S W Kim, MD, PhD principal investigator
the Catholic University of Korea St. Mary's Hospital
D G Moon, MD, PhD principal investigator
Korea University Guro Hospital
J J Kim, MD, PhD principal investigator
Korea University Anam Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DA-8159 (Udenafil) in people with Erectile Dysfunction, run by Dong-A Pharmaceutical Co., Ltd..
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 4 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 24 Jan 2013. 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. 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?
IIEF EF domain score (time frame: 24 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 24 Jan 2013.