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

NCT00724477 | Completed Results

• 1 other identifier: P05103
• Study Type: observational
• Target: 1,663
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

INEGY DRUG

Ezetimibe 10mg - Simvastatine 20 mg or 40 mg; Tablet - OD; Patient currently treated for INEGY for at least 4 weeks

Also known as: SCH 465981

Subjects treated with INEGY

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Interventions

Ezetimibe, Simvastatin Drug Combination

Intervention Hierarchy (Ancestors)

Simvastatin; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ezetimibe; Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 29, 2008
• Study Start: October 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: February 9, 2022
• Results First Posted: February 26, 2010

Record last verified: 2022-02