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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Dyslipidemias
Hypertension
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Fluvastatin
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anticholesteremic Agents
Antihypertensive Agents
Antimetabolites
Cardiovascular Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014