Efficacy and Safety of Fluvastatin or Valsartan and Their Combination in Dyslipidemic Patients With Hypertension and Endothelial Dysfunction

Novartis

Status and phase: Completed; Phase 4

Conditions: Hypertension; Dyslipidemia

Treatments: Drug: valsartan, fluvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00171327

CXUO320BRU01

Details and patient eligibility

About

Patients with mild to moderate hypertension, dyslipidemia (imbalanced blood lipids) and decreased vascular dilatation, receiving a cholesterol lowering diet were given either valsartan or fluvastatin for 8 weeks. At week 8 all patients were administered a combination treatment with valsartan 160 mg and fluvastatin 80 mg.

Enrollment: 213 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Arterial hypertension
• Dyslipidemia
• Cholesterol lowering diet

Exclusion criteria

• Constant antihypertensive treatment
• Diabetes mellitus
• Myocardial infarction or stroke in the previous 3 months

Other inclusion and exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)