NCT00241072

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Sep 2002

Typical duration for phase_4 hypertension

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2005

Completed
Last Updated

May 4, 2012

Status Verified

May 1, 2012

Enrollment Period

2.8 years

First QC Date

October 14, 2005

Last Update Submit

May 3, 2012

Conditions

HypertensionImpaired Glucose Tolerance

Outcome Measures

Primary Outcomes (1)

  • Change from baseline insulin sensitivity after 24 weeks

Secondary Outcomes (5)

  • 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

Interventions

valsartanDRUG

24 WEEKS OF TREATMENT WITH VALSARTAN (80 MG - 320 MG)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • history or presenting hypertension Elevated fasting blood glucose levels -

You may not qualify if:

  • Pregnancy potential Diabetes mellitus
  • Other criteria apply

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypertensionGlucose Intolerance

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2005

First Posted

October 18, 2005

Study Start

September 1, 2002

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

May 4, 2012

Record last verified: 2012-05