| Trial ID: | L5574 |
| Source ID: | NCT00170937
|
| Associated Drug: |
Valsartan Plus Hydrochlorothiazide
|
| Title: |
A 16 Week Study to Evaluate the Effect on Insulin Sensitivity of Valsartan (320 mg) and Hydrochlorothiazide (25 mg) Combined and Alone, in Patients With Metabolic Syndrome
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
METABOLIC SYNDROME|HYPERTENSION|PRE-HYPERTENSION
|
| Interventions: |
DRUG: valsartan plus hydrochlorothiazide
|
| Outcome Measures: |
Primary: Change from baseline in insulin sensitivity after 16 weeks | Secondary: Change from baseline in markers of inflammation and thrombosis after 16 weeks|Change from baseline in fasting plasma glucose and fasting insulin after 16 weeks|Change from baseline in lipid profile after 16 weeks|Change from baseline in a measurement of beta cell function after 16 weeks|Adverse events, serious adverse events, laboratory values, physical examinations, and vital signs for up to 16 weeks
|
| Sponsor/Collaborators: |
Sponsor: Novartis
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
507
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: PREVENTION
|
| Start Date: |
2004-11
|
| Completion Date: |
|
| Results First Posted: |
|
| Last Update Posted: |
2016-11-18
|
| Locations: |
Novartis Pharmaceuticals, E. Hanover, New Jersey, 07936, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00170937
|
