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

This study has been completed.

First Received: September 12, 2005 Last Updated: March 20, 2008 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171327

Purpose

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.

Condition	Intervention	Phase
Hypertension Dyslipidemia	Drug: valsartan, fluvastatin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol High Blood Pressure

Drug Information available for: Fluvastatin Valsartan

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	100
Study Start Date:	July 2004

Eligibility

Ages Eligible for Study:	30 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171327

Locations

Russian Federation
Novartis
Moscow, Russian Federation

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	CXUO320BRU01
Study First Received:	September 12, 2005
Last Updated:	March 20, 2008
ClinicalTrials.gov Identifier:	NCT00171327 History of Changes
Health Authority:	Russia: Pharmacological Committee, Ministry of Health

Keywords provided by Novartis:

arterial hypertension
dyslipidemia
valsartan
fluvastatin

Additional relevant MeSH terms:

Antimetabolites
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Anticholesteremic Agents
Antihypertensive Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Fluvastatin
Therapeutic Uses
Cardiovascular Diseases
Dyslipidemias
Valsartan
Hypertension
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010