The Effect of Fluvastatin XL® Treatment in Patients With Metabolic Syndrome

Novartis

Status and phase: Completed; Phase 4

Conditions: Metabolic Syndrome

Treatments: Drug: Fluvastatin XL®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00664742

CXUO320BTR03

Details and patient eligibility

About

This study evaluated safety, tolerability and efficacy of Fluvastatin XL® -extended release (80 mg once daily) in patients with metabolic syndrome

Enrollment: 614 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥ 3 criteria for metabolic syndrome National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III criteria)
• Triglyceride (TG) < 400 mg/dl and Low Density Lipoprotein-Cholesterol (LDL-C) 100 mg/dl to 190 mg/dl
• Written informed consent for participating in the study

Exclusion criteria

• Severe renal disease or renal dysfunction
• Chronic liver disease or liver function impairment
• Inflammatory muscle dysfunction or findings of muscle problems
• Severe cardiac failure

Other protocol defined inclusion exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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614 participants in 1 patient group

Fluvastatin XL® Treatment

Experimental group

Description:

80 mg once daily, at bedtime.

Treatment:

Drug: Fluvastatin XL®