Back to resultsClinical Trial To Evaluate The Effect Of Valsartan On Insulin Sensitivity In Subjects With Impaired Glucose Tolerance
Primary Purpose
Hypertension, Impaired Glucose Tolerance
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
valsartan
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
Inclusion Criteria: history or presenting hypertension Elevated fasting blood glucose levels - Exclusion Criteria: Pregnancy potential Diabetes mellitus Other criteria apply -
Sites / Locations
Outcomes
Primary Outcome Measures
Change from baseline insulin sensitivity after 24 weeks
Secondary Outcome Measures
Change from baseline in the function of cells that line blood vessels after 24 weeks
Change from baseline in markers of vascular inflammation after 24 weeks
Adverse events and serious adverse events at each study visit for 24 weeks
Hematology, blood chemistries, and urine measurements for up to 24 weeks
Vital signs and physical examinations for up to 24 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00241072
Brief Title
Clinical Trial To Evaluate The Effect Of Valsartan On Insulin Sensitivity In Subjects With Impaired Glucose Tolerance
Official Title
A Single Center, Open Label, Single Arm Trial To Evaluate The Effect Of Twenty Four Weeks Of Treatment With 80 Mg To 320 Mg Valsartan On Insulin Sensitivity In Subjects With Impaired Glucose Tolerance (Igt)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (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 DETERMINE IF 24 WEEKS OF TREATMENT WITH VALSARTAN (80 MG - 320 MG) IMPROVES INSULIN SENSITIVITY IN SUBJECTS WITH HIGHER THAN NORMAL GLUCOSE LEVELS USING A TEST CALLED THE EUGLYCEMIC CLAMP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Impaired Glucose Tolerance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
valsartan
Intervention Description
24 WEEKS OF TREATMENT WITH VALSARTAN (80 MG - 320 MG)
Primary Outcome Measure Information:
Title
Change from baseline insulin sensitivity after 24 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in the function of cells that line blood vessels after 24 weeks
Title
Change from baseline in markers of vascular inflammation after 24 weeks
Title
Adverse events and serious adverse events at each study visit for 24 weeks
Title
Hematology, blood chemistries, and urine measurements for up to 24 weeks
Title
Vital signs and physical examinations for up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
history or presenting hypertension Elevated fasting blood glucose levels -
Exclusion Criteria:
Pregnancy potential Diabetes mellitus
Other criteria apply
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial To Evaluate The Effect Of Valsartan On Insulin Sensitivity In Subjects With Impaired Glucose Tolerance
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