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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

Primary Purpose

METABOLIC SYNDROME, HYPERTENSION, PRE-HYPERTENSION

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

valsartan plus hydrochlorothiazide

About this trial

This is an interventional prevention trial for METABOLIC SYNDROME focused on measuring METABOLIC SYNDROME, VALSARTAN, HYDROCHLOROTHIAZIDE, HYPERTENSION,

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Novartis Pharmaceuticals

Outcomes

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

Full Information

NCT ID

NCT00170937

First Posted

September 10, 2005

Last Updated

November 16, 2016

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00170937

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

November 2004 (undefined)

Primary Completion Date

March 2006 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

METABOLIC SYNDROME, HYPERTENSION, PRE-HYPERTENSION

Keywords

METABOLIC SYNDROME, VALSARTAN, HYDROCHLOROTHIAZIDE, HYPERTENSION,

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

507 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

valsartan plus hydrochlorothiazide

Primary Outcome Measure Information:

Title

Change from baseline in insulin sensitivity after 16 weeks

Secondary Outcome Measure Information:

Title

Change from baseline in markers of inflammation and thrombosis after 16 weeks

Title

Change from baseline in fasting plasma glucose and fasting insulin after 16 weeks

Title

Change from baseline in lipid profile after 16 weeks

Title

Change from baseline in a measurement of beta cell function after 16 weeks

Title

Adverse events, serious adverse events, laboratory values, physical examinations, and vital signs for up to 16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Pharmaceuticals

City

E. Hanover

State/Province

New Jersey

ZIP/Postal Code

07936

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19120715

Citation

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.

Results Reference

result

Learn more about this trial

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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