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

Novartis

Status and phase: Completed; Phase 4

Conditions: Hypertension, Dyslypidaemia

Treatments: Drug: Valsartan; Drug: Hydrochlorothiazide; Drug: Fluvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00821574

CXUO320BIT02

Details and patient eligibility

About

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.

Enrollment: 144 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

144 participants in 3 patient groups

1

Experimental group

Description:

Fluvastatin: daily 80 mg, oral

Treatment:

Drug: Fluvastatin

2

Experimental group

Description:

Valsartan

Treatment:

Drug: Valsartan

3

Experimental group

Description:

Hydrochlorothiazide

Treatment:

Drug: Hydrochlorothiazide