Reducing the Overall Risk Level in Patients Suffering From Metabolic Syndrome

Novartis144 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

144

Conditions

Hypertension, Dyslypidaemia

Interventions

FluvastatinDRUG

Fluvastatin: daily 80 mg, oral

ValsartanDRUG

Valsartan: daily 160 mg, oral

HydrochlorothiazideDRUG

Hydrochlorothiazide: daily 12.5mg, oral

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

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)

Time frame: 9 month

Proportion of patients with controlled glycemia

Time frame: 9 months

Percentage of patients no longer classifiable as having metabolic syndrome

Time frame: 9 months

Data from ClinicalTrials.gov

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