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

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Sponsor:

Information provided by:

Novartis

Study Description

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 Design

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Study Type :	Interventional (Clinical Trial)
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
Actual Primary Completion Date :	March 2006

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Hypertension

MedlinePlus related topics: Metabolic Syndrome

Drug Information available for: Hydrochlorothiazide Valsartan

U.S. FDA Resources

Arms and Interventions

Outcome Measures

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
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.

Contacts and Locations

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

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United States, New Jersey
Novartis Pharmaceuticals
E. Hanover, New Jersey, United States, 07936

Sponsors and Collaborators

Novartis

Investigators

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Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

Publications of Results:

Zappe DH, Sowers JR, Hsueh WA, Haffner SM, Deedwania PC, Fonseca VA, Keeling L, Sica DA. Metabolic and antihypertensive effects of combined angiotensin receptor blocker and diuretic therapy in prediabetic hypertensive patients with the cardiometabolic syndrome. J Clin Hypertens (Greenwich). 2008 Dec;10(12):894-903. doi: 10.1111/j.1751-7176.2008.00054.x.

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ClinicalTrials.gov Identifier:	NCT00170937
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:

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Hypertension Prehypertension Metabolic Syndrome Insulin Resistance Syndrome Disease Pathologic Processes Vascular Diseases Cardiovascular Diseases Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases	Valsartan Hydrochlorothiazide 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

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