Status:
COMPLETED
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
Lead Sponsor:
Novartis
Conditions:
METABOLIC SYNDROME
HYPERTENSION
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
507 Patients enrolled
Trial Details
Trial ID
NCT00170937
Start Date
November 1 2004
Last Update
November 18 2016
Active Locations (1)
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1
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936