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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

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ClinicalTrials.gov Identifier: NCT00170937
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 18, 2016
Sponsor:
Information provided by:
Novartis

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.

Condition or disease Intervention/treatment Phase
METABOLIC SYNDROME HYPERTENSION PRE-HYPERTENSION Drug: valsartan plus hydrochlorothiazide Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 507 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A 16 Week Study to Evaluate the Effect on Insulin Sensitivity of Valsartan and Hydrochlorothiazide Combined and Alone, in Patients With Metabolic Syndrome
Study Start Date : November 2004
Primary Completion Date : March 2006





Primary Outcome Measures :
  1. Change from baseline in insulin sensitivity after 16 weeks

Secondary Outcome Measures :
  1. Change from baseline in markers of inflammation and thrombosis after 16 weeks
  2. Change from baseline in fasting plasma glucose and fasting insulin after 16 weeks
  3. Change from baseline in lipid profile after 16 weeks
  4. Change from baseline in a measurement of beta cell function after 16 weeks
  5. Adverse events, serious adverse events, laboratory values, physical examinations, and vital signs for up to 16 weeks


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00170937


Locations
United States, New Jersey
Novartis Pharmaceuticals
E. Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00170937     History of Changes
Other Study ID Numbers: CVAL489A2426
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016

Keywords provided by Novartis:
METABOLIC SYNDROME, VALSARTAN, HYDROCHLOROTHIAZIDE, HYPERTENSION,

Additional relevant MeSH terms:
Syndrome
Hypertension
Metabolic Syndrome X
Insulin Resistance
Prehypertension
Disease
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Valsartan
Hydrochlorothiazide
Insulin
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Hypoglycemic Agents