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

Primary Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00724477
• Other study ID #: P05103
• Status: Completed
• Start date: October 2007
• Est. completion date: August 2008

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The type of patient sampling used was consecutive patient sampling

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1663
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia
• Primary Hypercholesterolemia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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