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Completed

NCT Number: NCT00724477

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

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.

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Key information

Conditions

Primary Hypercholesterolemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

The type of patient sampling used was consecutive patient sampling

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

INEGY

Drug

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

Other names: SCH 465981

Primary outcomes

  1. Number of Participants Reaching the Targeted LDL-C Levels

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 29, 2008
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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