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: April 29, 2014
Last verified: April 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: April 29, 2014
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 August 01, 2014