Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00351065
Status:
TERMINATED
Last Update Posted:
2006-07-12
First Post:
2006-07-11
Brief Title:
Phase II Trial of SK3530 in Erectile Dysfunction
Sponsor:
SK Chemicals Co Ltd
Organization:
SK Chemicals Co Ltd
Study Overview
Official Title:
an 8week Multi-Center Randomized Double Blind Placebo-ControlledParallel Group Fixed Dose Dose-Finding Study to Assess the Efficacy and Safety of SK3530 in Patients With Erectile Dysfunction
Status:
TERMINATED
Status Verified Date:
2006-07
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:
This study was designed to evaluate the efficacy and safety of the SK3530 tablet and to find the optimal dose and dosage schedule after oral administration to patients with erectile dysfunction
Detailed Description:
Double-blind Placebo-controlled randomized parallel group fixed dose multi-center dose-finding study
The patients voluntarily signed the informed consent form of the clinical study and underwent a screening After completing the four-week run-in period they were randomly assigned to either a placebo group or one of the three SK3530 groups 50mg 100mg and 150mg The study was conducted in a double-blind manner A different dose of SK3530 was administered to the subjects depending on the assigned treatment group for 8 weeks Patients visit took place at week 4 and week 8 after randomization and at 6 or 7days after end of study
The patients voluntarily signed the informed consent form of the clinical study and underwent a screening After completing the four-week run-in period they were randomly assigned to either a placebo group or one of the three SK3530 groups 50mg 100mg and 150mg The study was conducted in a double-blind manner A different dose of SK3530 was administered to the subjects depending on the assigned treatment group for 8 weeks Patients visit took place at week 4 and week 8 after randomization and at 6 or 7days after end of study
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