Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00474240
Status:
COMPLETED
Last Update Posted:
2018-03-20
First Post:
2007-05-14
Brief Title:
AEGR-733 and Atorvastatin 20 mg vs Monotherapy in Moderate Hypercholesterolemia
Sponsor:
Aegerion Pharmaceuticals Inc
Organization:
Aegerion Pharmaceuticals Inc
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Parallel Group Study to Evaluate the Safety and Efficacy of the Combination of AEGR-733 Formerly BMS201038 and Atorvastatin 20 mg vs Monotherapy in Subjects With Moderate Hypercholesterolemia
Status:
COMPLETED
Status Verified Date:
2013-01
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 is to test the effectiveness of the study drug AEGR-733 alone and in combination with the medication atorvastatin Lipitor on cholesterol in volunteers with moderately high cholesterol
Detailed Description:
Recent studies suggest more intensive cholesterol lowering treatment for people at very high risk of a heart attack specifically for patients who have heart disease plus major risk factors Available medications used alone at even the highest approved doses are not expected to reach these new target recommendations for cholesterol in a large number of subjects Thus the development of new medications that can provide additional cholesterol lowering may be beneficial
This study tests the effectiveness of different doses of the study drug AEGR-733 alone and in combination with the approved cholesterol lowering drug atorvastatin Lipitor on cholesterol Volunteers will be randomized to one of 6 different study treatments and will take the assigned medication 3 capsules daily for 8 weeks
This study tests the effectiveness of different doses of the study drug AEGR-733 alone and in combination with the approved cholesterol lowering drug atorvastatin Lipitor on cholesterol Volunteers will be randomized to one of 6 different study treatments and will take the assigned medication 3 capsules daily for 8 weeks
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