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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00241072
First received: October 14, 2005
Last updated: May 3, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
Impaired Glucose Tolerance
 Drug: valsartan
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Drug Information available for: Valsartan
U.S. FDA Resources

Further study details as provided by Novartis:

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

Enrollment: 27
Study Start Date: September 2002
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: valsartan
    24 WEEKS OF TREATMENT WITH VALSARTAN (80 MG - 320 MG)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

history or presenting hypertension Elevated fasting blood glucose levels -

Exclusion Criteria:

Pregnancy potential Diabetes mellitus

Other criteria apply

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00241072

Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00241072     History of Changes
Other Study ID Numbers: CVAL489A2412
Study First Received: October 14, 2005
Last Updated: May 3, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Glucose Intolerance
Insulin Resistance
Vascular Diseases
Cardiovascular Diseases
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Hyperinsulinism
 Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013