Erectile DysfunctionPhase 3NCT01901640
Safety Study of Once-a-Day Dosing 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
Phase : Phase III Indication : Erectile Dysfunction Study Design : open-label, fixed dose, 6-month extension study (parent study : DA8159_EDD_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?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Nov 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 erectile dysfunction(ED)
Who cannot join
- Had uncontrolled blood pressure
- Had hepatic or renal dysfunction
- Had significant psychiatric disorders or drug abuses
- Was currently under anticancer chemotherapy
- Had a treatments for ED using other phosphodiesterase type 5(PDE-5) inhibitors
About this study
Official title: Phase 3 Study to Evaluate Longterm Safety of Once-a-Day Dosing of Udenafil in the Treatment of Erectile Dysfunction
Phase : Phase III Indication : Erectile Dysfunction Study Design : open-label, fixed dose, 6-month extension study (parent study : DA8159_EDD_III)
Read the detailed description
Completer from parent study(DA8159_EDD_III)continued into a 24weeks open-label extension during which they received udenafil once daily. The study concluded with a 4-week ED treatment-free period.
- Conditions
- Erectile Dysfunction
- Being tested
- DA-8159 (Udenafil)
- 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
| Study group | Role | What they receive |
|---|---|---|
| DA-8159 | Experimental | Udenafil(The study had one arm.) Receives: Drug: DA-8159 (Udenafil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Safety evaluation included adverse events, standard 12-lead electrocardiograms and clinical laboratory measures. The AEs measured as percentage and number of patients.
Measured: 48 weeks(after 24 weeks of parent study), 52weeks(after 28weeks of parent study)
Secondary outcomes (1)
International Index of Erectile Function(IIEF), GAQ(Global Assessment Questions), Shift to normal
The efficacy measures(Unit of Measure)
- IIEF EF domain score(Change from baseline)
- IIEF other domain scores(Change from baseline)
- GAQ \& Shift to normal(percentage of subject)
Measured: 48 weeks(after 24 weeks of parent study), 52weeks(after 28weeks of parent study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startNov 2011
- Primary completionNov 2012
- Study completionNov 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 302 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
- NCT01901640
- Sponsor's protocol ID
- DA8159_EDDL_III
- Status last verified
- Jan 2013
- First submitted
- 22 Jan 2013
- Last updated
- 17 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study to Evaluate Longterm Safety of Once-a-Day Dosing of Udenafil in the Treatment of Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT01901640
- Acronym / sponsor ID
- DA8159_EDDL_III
- Conditions
- Erectile Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 17 Jul 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.
Phase : Phase III Indication : Erectile Dysfunction Study Design : open-label, fixed dose, 6-month extension study (parent study : DA8159_EDD_III)
Detailed description
Completer from parent study(DA8159_EDD_III)continued into a 24weeks open-label extension during which they received udenafil once daily. The study concluded with a 4-week ED treatment-free period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DA-8159 | Experimental | Drug: DA-8159 (Udenafil)Udenafil(The study had one arm.) |
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 erectile dysfunction(ED)
Key exclusion criteria (5 listed)
- Had uncontrolled blood pressure
- Had hepatic or renal dysfunction
- Had significant psychiatric disorders or drug abuses
- Was currently under anticancer chemotherapy
- Had a treatments for ED using other phosphodiesterase type 5(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 |
Primary outcome
Safety
Time frame: 48 weeks(after 24 weeks of parent study), 52weeks(after 28weeks of parent study)
Safety evaluation included adverse events, standard 12-lead electrocardiograms and clinical laboratory measures. The AEs measured as percentage and number of patients.
1 secondary outcome
International Index of Erectile Function(IIEF), GAQ(Global Assessment Questions), Shift to normal
Time frame: 48 weeks(after 24 weeks of parent study), 52weeks(after 28weeks of parent study)
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 17 Jul 2013.
Related trials for Erectile Dysfunction
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction
Not yet recruiting
Erectile Function PRESERVation in Definitive Radiotherapy for Prostate Cancer by MRI-Enhanced Adaptive Sparing of the Neurovascular Bundle
Prostate Cancer, Localized Prostate Carcinoma
RecruitingPhase 4
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
Peyronie's Disease
RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
Erectile Dysfunction
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 5 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 17 Jul 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. 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?
Safety (time frame: 48 weeks(after 24 weeks of parent study), 52weeks(after 28weeks of parent study)). 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 17 Jul 2013.