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

Novartis213 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

213

Conditions

Hypertension Dyslipidemia

Interventions

valsartan, fluvastatinDRUG

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis

Moscow, Russia

Outcomes

Primary Outcomes

Percent change from baseline in brachial artery flow-mediated vasodilation after 8 weeks

Percent change from baseline in brachial artery flow-mediated vasodilation after 16 weeks compared to 8 weeks

Secondary Outcomes

Percent change from baseline in low density lipoprotein cholesterol, total cholesterol, and triglycerides

Evaluating blood pressure effect on endothelial function

Evaluating total cholesterol effect on endothelial function

Data from ClinicalTrials.gov

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