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

Phase 4

Completed

• Conditions: Hypertension; Dyslipidemia

• Registration Number: NCT00171327
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-07
• Last Update Posted: 2011-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Evaluating blood pressure effect on endothelial function
Evaluating total cholesterol effect on endothelial function
Percent change from baseline in low density lipoprotein cholesterol, total cholesterol, and triglycerides

Trial Locations

Locations (1)

Novartis; 🇷🇺 Moscow, Russian Federation