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 on September 12, 2005. Last Updated on November 7, 2011 History of Changes

Sponsor:	Novartis
Information provided by (Responsible Party):	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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Enrollment:	213
Study Start Date:	July 2004
Study Completion Date:	September 2005
Primary Completion Date:	September 2005 (Final data collection date for primary outcome measure)

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

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00171327 History of Changes
Other Study ID Numbers:	CXUO320BRU01
Study First Received:	September 12, 2005
Last Updated:	November 7, 2011
Health Authority:	Russia: Pharmacological Committee, Ministry of Health

Keywords provided by Novartis:

arterial hypertension
dyslipidemia
valsartan
fluvastatin

Additional relevant MeSH terms:

Hypertension
Dyslipidemias
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Fluvastatin
Valsartan
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012