Clinical Trial To Evaluate The Effect Of Valsartan On Insulin Sensitivity In Subjects With Impaired Glucose Tolerance

Hypertension Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00241072
• Other study ID #: CVAL489A2412
• Status: Completed
• Phase: Phase 4
• First received: October 14, 2005
• Last updated: May 3, 2012
• Start date: September 2002
• Est. completion date: July 2005

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

history or presenting hypertension Elevated fasting blood glucose levels -

Exclusion Criteria:

Pregnancy potential Diabetes mellitus

Other criteria apply

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glucose Intolerance
• Hypertension
• Impaired Glucose Tolerance

Intervention

Drug:
• valsartan
24 WEEKS OF TREATMENT WITH VALSARTAN (80 MG - 320 MG)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline insulin sensitivity after 24 weeks
Secondary	Change from baseline in the function of cells that line blood vessels after 24 weeks
Secondary	Change from baseline in markers of vascular inflammation after 24 weeks
Secondary	Adverse events and serious adverse events at each study visit for 24 weeks
Secondary	Hematology, blood chemistries, and urine measurements for up to 24 weeks
Secondary	Vital signs and physical examinations for up to 24 weeks