Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169559
Status:
COMPLETED
Last Update Posted:
2012-10-22
First Post:
2005-09-09
Brief Title:
Dyslipidemia Study Investigating The Increase In Good Cholesterol
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Multi-center Three-staged Randomized Parallel Group Sequential Double-blind fenofibrate-and Placebo-controlled Dose-response Evaluation of the Safety Tolerability and Effects on Plasma HDLc and TG of Eight Weeks Treatment With 1µg to 20µg Daily Doses of GW590735 in Otherwise Healthy Subjects With Low HDLc Mildly to Moderately Elevated TG and Normal LDLc
Status:
COMPLETED
Status Verified Date:
2012-10
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:
An eight week comparison of the investigational drug GW590735 placebo and the marketed drug fenofibrate intended to increase the levels of good cholesterol and decrease levels of bad cholesterol in healthy patients with low levels of good cholesterol and high levels of bad cholesterol
Detailed Description:
A multi-center three-staged randomized parallel group sequential double-blind fenofibrate-and placebo-controlled dose-response evaluation of the safety tolerability and effects on plasma HDLc and TG of eight weeks treatment with 1µg to 20µg daily doses of GW590735 in otherwise healthy subjects with low HDLc mildly to moderately elevated TG and normal LDLc
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