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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00171327
First received: September 12, 2005
Last updated: November 7, 2011
Last verified: November 2011
History of Changes
  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 4

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:

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 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 May 23, 2013