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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00171327

Enrollment

213

Registered

2005-09-15

Start date

2004-07-31

Completion date

2005-09-30

Last updated

2011-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia, Hypertension

Keywords

arterial hypertension, dyslipidemia, valsartan, fluvastatin

Brief summary

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.

Interventions

DRUGvalsartan, fluvastatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026