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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00724477
First received: July 25, 2008
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Primary Hypercholesterolemia
Drug: INEGY

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: PRAGMATIC (This is the True Official Title of the Protocol for This Study)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants Reaching the Targeted LDL-C Levels [ Time Frame: 1 to 3 months after starting treatment ] [ Designated as safety issue: No ]

    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.


Enrollment: 1663
Study Start Date: October 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: SCH 465981

Detailed Description:

The type of patient sampling used was consecutive patient sampling

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00724477     History of Changes
Other Study ID Numbers: P05103
Study First Received: July 25, 2008
Results First Received: November 24, 2009
Last Updated: October 25, 2013
Health Authority: France: Commission nationale de l'Informatique et des Libertés

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014