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

Condition(s) targeted: Hypertension; Dyslipidemia

Intervention: valsartan, fluvastatin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Principal Investigator, Affiliation: Novartis

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.

Official title: Efficacy and Safety of Fluvastatin 80 mg or Valsartan 160 mg and Their Combination in Dyslipidemic Patients With Arterial Hypertension and Endothelial Dysfunction

Study design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

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 outcome:

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

Minimum age: 30 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Novartis, Moscow, Russian Federation

Starting date: July 2004
Last updated: March 20, 2008