Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282607
Status:
COMPLETED
Last Update Posted:
2007-02-28
First Post:
2006-01-25
Brief Title:
A Study of DA-8159 in Subjects With Erectile Dysfunction
Sponsor:
Dong-A PharmTech Co Ltd
Organization:
Dong-A PharmTech Co Ltd
Study Overview
Official Title:
A Randomized Placebo-Controlled Double-Blind Parallel Design Phase 2 Dose Ranging Trial To Assess The Safety and Efficacy of DA-8159 Tablets in Male Subjects With Erectile Dysfunction
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study will be to evaluate the clinical efficacy and safety of DA-8159 an orally administered potent and selective inhibitor of PDE5 versus placebo for the treatment of subjects with erectile dysfunction ED
Detailed Description:
This will be a multi-center randomized double-blind placebo-controlled parallel-group study in 300 erectile dysfunction patients Patients will complete a screening visit V1 to determine eligibility for the study based on the International Index of Erectile Function IIEF erectile function EF domain scores patient history and safety measures Patients that meet the entrance criteria for this study will enter a 4 week drug-free run-in period to establish a baseline for the erectile function domain score and to meet the criteria for participation in the study
Patients successfully completing screen will be randomly assigned to one of four treatment groups at Visit 2 V2 placebo or one of 3 active drug doses of DA-8159 tablets Patients will be given medication for at-home use and will also be given diaries for recording information regarding sexual encounters quality of erections and adverse events At 4-week intervals for 3 months V3 V4 V5 patients will return to the clinic to review and collect SEP diaries safety data 12-lead ECG and medication reconciliation In addition at each 4-week interval patients will complete an IIEF and at Visit 5 will have blood drawn for safety evaluation
The primary efficacy end points are a the change in score baseline to Visit 5 for the Erectile Function domain score of the IIEF b change in response relative to baseline for sexual encounter profile SEP question 2 and c change in response relative to baseline for SEP question 3 For DA-8159 tablets to be judged efficacious the DA-8159 tablet groups must be shown superior to the placebo group on all three measures
Patients successfully completing screen will be randomly assigned to one of four treatment groups at Visit 2 V2 placebo or one of 3 active drug doses of DA-8159 tablets Patients will be given medication for at-home use and will also be given diaries for recording information regarding sexual encounters quality of erections and adverse events At 4-week intervals for 3 months V3 V4 V5 patients will return to the clinic to review and collect SEP diaries safety data 12-lead ECG and medication reconciliation In addition at each 4-week interval patients will complete an IIEF and at Visit 5 will have blood drawn for safety evaluation
The primary efficacy end points are a the change in score baseline to Visit 5 for the Erectile Function domain score of the IIEF b change in response relative to baseline for sexual encounter profile SEP question 2 and c change in response relative to baseline for SEP question 3 For DA-8159 tablets to be judged efficacious the DA-8159 tablet groups must be shown superior to the placebo group on all three measures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None