Ignite Creation Date:
2025-12-17 @ 2:59 PM
Ignite Modification Date:
2025-12-23 @ 4:52 PM
Study NCT ID:
NCT00748592
Status:
WITHDRAWN
Last Update Posted:
2009-02-12
First Post:
2008-09-05
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Dose-Ranging, Multicenter Polysomnography Trial of PD 0200390 in Elderly Subjects With Primary Insomnia
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
PD 0200390 Dose-Ranging Trial: A Randomized, Double-Blind, Placebo-Controlled, 4-Way Crossover, Multicenter Polysomnography Trial Of PD 0200390 In Elderly Subjects With Primary Insomnia
Status:
WITHDRAWN
Status Verified Date:
2009-02
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:
This is a randomized, double-blind, placebo-controlled, multicenter trial with a 4-way crossover design. Elderly subjects with primary insomnia who meet screening requirements will initially be randomized into the study and receive the first of 4 treatments (PD 0200390 5 mg, 15 mg and 30 mg or placebo) daily 30 minutes before bed time for 2 consecutive days in a polysomnography (PSG) lab.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: