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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
History of Changes
  Purpose

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 Intervention Phase
Metabolic Syndrome
Hypertension
Pre-Hypertension
 Drug: valsartan plus hydrochlorothiazide
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 507
Study Start Date: November 2004
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00170937     History of Changes
Other Study ID Numbers: CVAL489A2426
Study First Received: September 10, 2005
Last Updated: September 19, 2008
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 21, 2013