Viewing Study NCT00166530



Ignite Creation Date: 2024-05-05 @ 11:53 AM
Last Modification Date: 2024-10-26 @ 9:15 AM
Study NCT ID: NCT00166530
Status: COMPLETED
Last Update Posted: 2022-02-18
First Post: 2005-09-09

Brief Title: EASEGO Study Doubling of AtorvastatinSimvastatin or INEGY in Patients With Hypercholesterolemia and Coronary Artery DiseaseCAD0653A-089
Sponsor: Organon and Co
Organization: Organon and Co

Study Overview

Official Title: A Prospective Randomized Open Label Blinded Endpoint Multicenter Study in Patients With Coronary Artery Disease to Assess the LDL Lowering Effect of Switching to Ezetimibe Simvastatin for Cholesterol Lowering Compared the Dose of the Statin Used
Status: COMPLETED
Status Verified Date: 2022-02
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: In patients with coronary artery disease and a LDL-C level between 25 mmolL and 50 mmolL on a stable 4 weeks statin starting dose simvastatin 20 mg or atorvastatin 10 mg investigate what the LCL-C lowering efficacy is of doubling the statin dose to 40 mg simvastatin or 20 mg atorvastatin versus a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily for 12 weeks It is postulated that more patients reach their LDL-C treatment goal with the combination tablet compared to doubling the starting dose Furthermore the effect of both treatment regimens on other lipid parameters safety and LDL-subfractions will be measured
Detailed Description: Patients with simvastatin 20 mg or atorvastatin 10 mg were randomized to 1 double statin dose to 40 mg simvastatin or 20 mg atorvastatin or 2 switch to a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily for 12 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
Secondary IDs
Secondary ID Type Domain Link
2005_059 None None None
MK0653A-089 None None None