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

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ClinicalTrials.gov Identifier: NCT00724477
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : February 26, 2010
Last Update Posted : September 30, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment
Primary Hypercholesterolemia Drug: INEGY

Detailed Description:
The type of patient sampling used was consecutive patient sampling

Study Type : Observational
Actual Enrollment : 1663 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: PRAGMATIC (This is the True Official Title of the Protocol for This Study)
Study Start Date : October 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00724477     History of Changes
Other Study ID Numbers: P05103
First Posted: July 29, 2008    Key Record Dates
Results First Posted: February 26, 2010
Last Update Posted: September 30, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe, Simvastatin Drug Combination
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents