Reducing the Overall Risk Level in Patients Suffering From Metabolic Syndrome

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%

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00821574

Acronym

LesScore

Enrollment

144

Registered

2009-01-13

Start date

2005-07-31

Completion date

2007-03-31

Last updated

2017-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Dyslypidaemia

Keywords

Hypertension, dyslipidemia

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.

Interventions

DRUGFluvastatin

Fluvastatin: daily 80 mg, oral

DRUGValsartan

Valsartan: daily 160 mg, oral

DRUGHydrochlorothiazide

Hydrochlorothiazide: daily 12.5mg, oral

Study design

Allocation

NON_RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 65 Years

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026