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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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00170937
First received: September 10, 2005
Last updated: September 19, 2008
Last verified: September 2008

September 10, 2005
September 19, 2008
November 2004
March 2006   (final data collection date for primary outcome measure)
Change from baseline in insulin sensitivity after 16 weeks
Not Provided
Complete list of historical versions of study NCT00170937 on ClinicalTrials.gov Archive Site
  • 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
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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
A 16 Week Study to Evaluate the Effect on Insulin Sensitivity of Valsartan and Hydrochlorothiazide Combined and Alone, in Patients With Metabolic Syndrome

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.

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Metabolic Syndrome
  • Hypertension
  • Pre-Hypertension
Drug: valsartan plus hydrochlorothiazide
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
507
Not Provided
March 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00170937
CVAL489A2426
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Novartis
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP