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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

NCT ID: NCT00170937

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

507 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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METABOLIC SYNDROME HYPERTENSION PRE-HYPERTENSION

Keywords

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METABOLIC SYNDROME, VALSARTAN, HYDROCHLOROTHIAZIDE, HYPERTENSION,

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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valsartan plus hydrochlorothiazide

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 19120715 (View on PubMed)

Other Identifiers

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CVAL489A2426

Identifier Type: -

Identifier Source: org_study_id