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

HYPERTENSION Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00170937
• Other study ID #: CVAL489A2426
• Status: Completed
• Phase: Phase 4
• First received: September 10, 2005
• Last updated: November 16, 2016
• Start date: November 2004

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 507
• Est. primary completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HYPERTENSION
• Insulin Resistance
• METABOLIC SYNDROME
• Metabolic Syndrome X
• PRE-HYPERTENSION
• Prehypertension
• Syndrome

Intervention

Drug:
• valsartan plus hydrochlorothiazide

Locations

Country	Name	City	State
United States	Novartis Pharmaceuticals	E. Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 syn — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in insulin sensitivity after 16 weeks
Secondary	Change from baseline in markers of inflammation and thrombosis after 16 weeks
Secondary	Change from baseline in fasting plasma glucose and fasting insulin after 16 weeks
Secondary	Change from baseline in lipid profile after 16 weeks
Secondary	Change from baseline in a measurement of beta cell function after 16 weeks
Secondary	Adverse events, serious adverse events, laboratory values, physical examinations, and vital signs for up to 16 weeks

External Links

•   Results for CVAL489A2426 from the Novartis Clinical Trials website