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 - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00170937

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 IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Insulin Valsartan

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

More Information

No publications provided

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

Keywords provided by Novartis:

METABOLIC SYNDROME, VALSARTAN, HYDROCHLOROTHIAZIDE, HYPERTENSION,

Additional relevant MeSH terms:

Disease
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide

Pharmacologic Actions
Membrane Transport Modulators
Pathologic Processes
Natriuretic Agents
Therapeutic Uses
Syndrome
Cardiovascular Diseases
Valsartan
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010