Back to resultsEfficacy and Safety of Fluvastatin or Valsartan and Their Combination in Dyslipidemic Patients With Hypertension and Endothelial Dysfunction
Primary Purpose
Hypertension, Dyslipidemia
Status
Completed
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
valsartan, fluvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring arterial hypertension, dyslipidemia, valsartan, fluvastatin
Eligibility 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
Sites / Locations
- Novartis
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00171327
Brief Title
Efficacy and Safety of Fluvastatin or Valsartan and Their Combination in Dyslipidemic Patients With Hypertension and Endothelial Dysfunction
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Dyslipidemia
Keywords
arterial hypertension, dyslipidemia, valsartan, fluvastatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
213 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
valsartan, fluvastatin
Primary Outcome Measure Information:
Title
Percent change from baseline in brachial artery flow-mediated vasodilation after 8 weeks
Title
Percent change from baseline in brachial artery flow-mediated vasodilation after 16 weeks compared to 8 weeks
Secondary Outcome Measure Information:
Title
Percent change from baseline in low density lipoprotein cholesterol, total cholesterol, and triglycerides
Title
Evaluating blood pressure effect on endothelial function
Title
Evaluating total cholesterol effect on endothelial function
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis
City
Moscow
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Fluvastatin or Valsartan and Their Combination in Dyslipidemic Patients With Hypertension and Endothelial Dysfunction
We'll reach out to this number within 24 hrs