Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00116740
Status:
COMPLETED
Last Update Posted:
2019-09-12
First Post:
2005-06-30
Brief Title:
Safety and Efficacy of APD356 in the Treatment of Obesity
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
A 12-Week Dose-Ranging Double-Blind Randomized Placebo-Controlled Parallel-Group Study to Assess the Safety and Efficacy of APD356 in Obese Patients
Status:
COMPLETED
Status Verified Date:
2006-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a research study of an investigational drug APD356 a novel selective 5-HT2c receptor agonist in clinical development as a potential treatment for obesity
The purpose of this study is to obtain a preliminary assessment of the safety and efficacy of APD356 when administered daily for 12 weeks in obese subjects who are otherwise healthy Subjects who are on concomitant medications for control of hypertension or blood lipids may qualify
The purpose of this study is to obtain a preliminary assessment of the safety and efficacy of APD356 when administered daily for 12 weeks in obese subjects who are otherwise healthy Subjects who are on concomitant medications for control of hypertension or blood lipids may qualify
Detailed Description:
This is a double-blind placebo-controlled randomized parallel group study Three different doses of APD356 or placebo will be administered daily for 12 weeks to obese male and nonpregnant nonlactating female volunteers aged 18 to 65 years Approximately 400 subjects will be enrolled
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