Back to resultsEffect of Valsartan on Lipid Subfractions in Hypertensive Patients With Metabolic Syndrome
Primary Purpose
Hypertension, Metabolic Syndrome
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Valsartan
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Metabolic Syndrome, lipid subfractions
Eligibility Criteria
Inclusion Criteria:
- Male or female outpatients >= 18 years of age at Visit 1
- Hypertension (systolic blood pressure >= 140 mmHg and < 170 mmHg and/or diastolic blood pressure >= 90 mmHg and < 105 mmHg
- Elevated triglycerides
- Metabolic syndrome as defined by Adult Treatment Panel III criteria
Exclusion Criteria:
- MSSBP >= 170 mmHg and/or MSDBP >= 105 mmHg at any time between Visit 1 and Visit 2
- Diabetes mellitus
- Patients treated with lipid lowering drugs in the last 6 weeks prior to Visit 1
- A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and peripheral artery disease, heart failure NYHA II - IV Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Novartis
Outcomes
Primary Outcome Measures
To evaluate the effect of valsartan 320 mg on small, dense low density lipoprotein (LDL) subfractions in hypertensive patients with metabolic syndrome.
Secondary Outcome Measures
To evaluate the effect of valsartan 320 mg on further lipid subfractions and enzymes related to the lipoprotein metabolism.
To evaluate the effect of valsartan 160-320 mg on blood pressure and pulse rate.
To assess the safety and tolerability of valsartan 160-320mg.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00394745
Brief Title
Effect of Valsartan on Lipid Subfractions in Hypertensive Patients With Metabolic Syndrome
Official Title
A 12 Week Treatment, Open-label, Multicenter Study to Investigate the Efficacy and Safety of Valsartan 160-320 mg With Regard to Effects on Lipid Subfractions in Hypertensive Patients With Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate potential effects of valsartan on lipid subfractions and other parameters in lipid metabolism in patients with essential hypertension and metabolic syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Metabolic Syndrome
Keywords
Hypertension, Metabolic Syndrome, lipid subfractions
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Valsartan
Primary Outcome Measure Information:
Title
To evaluate the effect of valsartan 320 mg on small, dense low density lipoprotein (LDL) subfractions in hypertensive patients with metabolic syndrome.
Secondary Outcome Measure Information:
Title
To evaluate the effect of valsartan 320 mg on further lipid subfractions and enzymes related to the lipoprotein metabolism.
Title
To evaluate the effect of valsartan 160-320 mg on blood pressure and pulse rate.
Title
To assess the safety and tolerability of valsartan 160-320mg.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female outpatients >= 18 years of age at Visit 1
Hypertension (systolic blood pressure >= 140 mmHg and < 170 mmHg and/or diastolic blood pressure >= 90 mmHg and < 105 mmHg
Elevated triglycerides
Metabolic syndrome as defined by Adult Treatment Panel III criteria
Exclusion Criteria:
MSSBP >= 170 mmHg and/or MSDBP >= 105 mmHg at any time between Visit 1 and Visit 2
Diabetes mellitus
Patients treated with lipid lowering drugs in the last 6 weeks prior to Visit 1
A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and peripheral artery disease, heart failure NYHA II - IV Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis + 41 61 324 1111 Basel
Organizational Affiliation
Novartis Basel+ 41 61 324 1111
Official's Role
Study Director
Facility Information:
City
Investigative Centers
Country
Germany
Facility Name
Novartis
City
Basel
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Effect of Valsartan on Lipid Subfractions in Hypertensive Patients With Metabolic Syndrome
We'll reach out to this number within 24 hrs