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Reducing the Overall Risk Level in Patients Suffering From Metabolic Syndrome (LesScore)

Primary Purpose

Hypertension, Dyslypidaemia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Fluvastatin
Valsartan
Hydrochlorothiazide
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension, Dyslypidaemia focused on measuring Hypertension, dyslipidemia

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 40 - 65 years
  • Diagnosed metabolic syndrome
  • Risk of cardiovascular death ≥ 5% (according to SCORE)
  • Written informed consent

Exclusion Criteria:

  • Women not in menopause or not using efficient contraception
  • Known hypersensitivity to study drugs
  • History of ischemic heart disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    1

    2

    3

    Arm Description

    Fluvastatin: daily 80 mg, oral

    Valsartan

    Hydrochlorothiazide

    Outcomes

    Primary Outcome Measures

    Change in global risk from baseline to 3 and 9 months, as evaluated by the SCORE algorithm

    Secondary Outcome Measures

    Change from baseline after 3 and 9 months in the individual risk factors (e.g. blood pressure, lipid variables)
    Proportion of patients with controlled glycemia
    Percentage of patients no longer classifiable as having metabolic syndrome

    Full Information

    First Posted
    January 12, 2009
    Last Updated
    February 28, 2017
    Sponsor
    Novartis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00821574
    Brief Title
    Reducing the Overall Risk Level in Patients Suffering From Metabolic Syndrome
    Acronym
    LesScore
    Official Title
    Project to Promote the Evaluation of the Cardiovascular Risk in the Clinical Practice and to Evaluate Its Evolution Following the Implementation of a Preventive Multifactorial Strategy Aimed to Reduce the Total Risk Level (SCORE Algorithm), in Subjects Suffering From Metabolic Syndrome and With a Risk Level ≥5%
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2005 (undefined)
    Primary Completion Date
    March 2007 (Actual)
    Study Completion Date
    March 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis

    4. Oversight

    5. Study Description

    Brief Summary
    This study will evaluate the efficacy of a multi factorial preventive scheme of action (including fluvastatin and valsartan) to reduce the overall risk level in patients with metabolic syndrome.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension, Dyslypidaemia
    Keywords
    Hypertension, dyslipidemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    144 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Fluvastatin: daily 80 mg, oral
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Valsartan
    Arm Title
    3
    Arm Type
    Experimental
    Arm Description
    Hydrochlorothiazide
    Intervention Type
    Drug
    Intervention Name(s)
    Fluvastatin
    Other Intervention Name(s)
    Lescol
    Intervention Description
    Fluvastatin: daily 80 mg, oral
    Intervention Type
    Drug
    Intervention Name(s)
    Valsartan
    Other Intervention Name(s)
    Diovan
    Intervention Description
    Valsartan: daily 160 mg, oral
    Intervention Type
    Drug
    Intervention Name(s)
    Hydrochlorothiazide
    Intervention Description
    Hydrochlorothiazide: daily 12.5mg, oral
    Primary Outcome Measure Information:
    Title
    Change in global risk from baseline to 3 and 9 months, as evaluated by the SCORE algorithm
    Time Frame
    9 months
    Secondary Outcome Measure Information:
    Title
    Change from baseline after 3 and 9 months in the individual risk factors (e.g. blood pressure, lipid variables)
    Time Frame
    9 month
    Title
    Proportion of patients with controlled glycemia
    Time Frame
    9 months
    Title
    Percentage of patients no longer classifiable as having metabolic syndrome
    Time Frame
    9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age between 40 - 65 years Diagnosed metabolic syndrome Risk of cardiovascular death ≥ 5% (according to SCORE) Written informed consent Exclusion Criteria: Women not in menopause or not using efficient contraception Known hypersensitivity to study drugs History of ischemic heart disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alessandro Rossi, MD
    Organizational Affiliation
    ASL Terni 4, Narni (TR) - Italy
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23334870
    Citation
    Ambrosioni E, Cicero AF, Parretti D, Filippi A, Rossi A, Peruzzi E, Borghi C. Global cardiovascular disease risk management in italian patients with metabolic syndrome in the clinical practice setting. High Blood Press Cardiovasc Prev. 2008 Apr;15(2):37-45. doi: 10.2165/00151642-200815020-00001. Epub 2013 Jan 3.
    Results Reference
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