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%

Novartis0 sites144 target enrollmentJuly 2005

ConditionsHypertension, Dyslypidaemia

InterventionsFluvastatin Valsartan Hydrochlorothiazide

DrugsFluvastatin Valsartan Hydrochlorothiazide

Overview

Phase: Phase 4
Intervention: Fluvastatin
Conditions: Hypertension, Dyslypidaemia
Sponsor: Novartis
Enrollment: 144
Primary Endpoint: Change in global risk from baseline to 3 and 9 months, as evaluated by the SCORE algorithm
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2005

End Date

March 2007

Last Updated

9 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

Novartis

Responsible Party

Sponsor

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

Arms & Interventions

1

Fluvastatin: daily 80 mg, oral

Intervention: Fluvastatin

2

Valsartan

Intervention: Valsartan

3

Hydrochlorothiazide

Intervention: Hydrochlorothiazide

Outcomes

Primary Outcomes

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

Time Frame: 9 months

Secondary Outcomes

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)