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

Condition(s) targeted: Metabolic Syndrome; Hypertension; Pre-Hypertension

Intervention: valsartan plus hydrochlorothiazide (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis

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.

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 design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in insulin sensitivity after 16 weeks

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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.

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

Starting date: November 2004
Last updated: August 6, 2007