Retrospective Evaluation of the Percentage of Subjects Who Have Reached Their LDL-C Objectives After Treatment With INEGY (Study P05103)(COMPLETED)

Completed

• Conditions: Primary Hypercholesterolemia
• Interventions: Drug: INEGY

• Registration Number: NCT00724477
• Lead Sponsor: Organon and Co

Brief Summary

The main objective of this study is to determine the percentage of patients who met the low-density lipoprotein cholesterol (LDL-C) objective with INEGY, that were not under statin monotherapy treatment.

Detailed Description

The type of patient sampling used was consecutive patient sampling

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-29
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Results First Submitted: 2009-11-24
• Results First Submitted QC: 2010-02-03
• Results First Posted: 2010-02-26
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1663

Inclusion Criteria

• man or woman aged over 18;
• patient suffering from primary hypercholesterolemia;
• patient justifying treatment with INEGY® (2nd intention);
• patient currently treated with INEGY® for at least 4 weeks;
• patient with a lipid profile before treatment with INEGY®, documenting a level of LDL-C exceeding the therapeutic objective under treatment with a statin as monotherapy;
• patient with an evaluation of lipid disorder (EAL) treated with INEGY®, performed within 1 to 3 months of starting treatment.

Exclusion Criteria

• patient not previously treated with a statin;
• patient previously treated with a combination of hypolipemics;
• patient treated with INEGY® as first intention;
• patient treated with INEGY® for less than 4 weeks;
• patient already included in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects treated with INEGY	INEGY	Subjects suffering from primary hypercholesterolemia that are not controlled by statins as a monotherapy, and are treated with INEGY

Primary Outcome Measures

Name	Time	Method
Number of Participants Reaching the Targeted LDL-C Levels	1 to 3 months after starting treatment	A subject was considered to have met targeted LDL-C levels (been controlled) if: * subject had no cardiovascular (CV) risk factors and level of LDL-C after initiating INEGY was lower than 2.2 g/L,; * subject had only 1 CV risk factor and level of LDL-C after initiating INEGY was lower than 1.9 g/L,; * subject had 2 CV risk factors and level of LDL-C after initiating INEGY was lower than 1.6 g/L,; * subject had 3 or more CV risk factors and level of LDL-C after initiating INEGY was lower than 1.3 g/L,; * subject had a high CV risk and level of LDL-C after initiating INEGY was lower than 1 g/L.