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
1 other identifier
interventional
507
1 country
1
Brief Summary
The metabolic syndrome is a classification for patients with a constellation of risk factors which may include abdominal obesity, hypertension, elevated blood lipids and sugar. Three or more of these factors together constitute the metabolic syndrome and place these patients at a greater risk for the development of diabetes and cardiovascular diseases. The purpose of this study is to determine whether two common drugs to lower blood pressure, whether used separately or in combination, have different effects on blood sugar levels in patients diagnosed with the metabolic syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
1 active site
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
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 10, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedNovember 18, 2016
November 1, 2016
1.3 years
September 10, 2005
November 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in insulin sensitivity after 16 weeks
Secondary Outcomes (5)
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
Interventions
Eligibility Criteria
You may qualify if:
- Waist circumference: males \> 40", females \> 35 "
- MSSBP ≥ 130 mmHg but ≤ 160 mmHg and a MSDBP ≥ 85 mmHg but ≤ 100 mmHg
- At least one of the following criteria: - Fasting plasma glucose between 5.9 and 6.9 mmol/L; - Serum triglycerides \> 150 mg/dL; - LDL Cholesterol: - \< 40 mg/dL males; - \< 50 mg/dL females
You may not qualify if:
- MSSBP\> 180 mmHg or MSDBP \> 110 mmHg
- Inability to discontinue all prior antihypertensives for a period of 4 weeks.
- History of diabetes
- History of stroke, transient ischemic attack or myocardial infarction.
- Significant weight change \> 10 lbs during screening period
- Patients taking a diuretic for 3 months prior to screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (1)
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936, United States
Related Publications (1)
Zappe DH, Sowers JR, Hsueh WA, Haffner SM, Deedwania PC, Fonseca VA, Keeling L, Sica DA. Metabolic and antihypertensive effects of combined angiotensin receptor blocker and diuretic therapy in prediabetic hypertensive patients with the cardiometabolic syndrome. J Clin Hypertens (Greenwich). 2008 Dec;10(12):894-903. doi: 10.1111/j.1751-7176.2008.00054.x.
PMID: 19120715RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 10, 2005
First Posted
September 15, 2005
Study Start
November 1, 2004
Primary Completion
March 1, 2006
Last Updated
November 18, 2016
Record last verified: 2016-11