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

PRAGMATIC (This is the True Official Title of the Protocol for This Study)

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.

Study Overview

• Status: Completed
• Conditions: Primary Hypercholesterolemia
• Intervention / Treatment: Drug: INEGY

Detailed Description

The type of patient sampling used was consecutive patient sampling

• Study Type: Observational
• Enrollment (Actual): 1663

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects treated with INEGY; Subjects suffering from primary hypercholesterolemia that are not controlled by statins as a monotherapy, and are treated with INEGY	Drug: INEGY; Ezetimibe 10mg - Simvastatine 20 mg or 40 mg; Tablet - OD; Patient currently treated for INEGY for at least 4 weeks; Other Names: SCH 465981

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reaching the Targeted LDL-C Levels	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.	1 to 3 months after starting treatment

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: July 25, 2008
• First Submitted That Met QC Criteria: July 25, 2008
• First Posted (Estimate): July 29, 2008

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: P05103