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

Novartis

Status and phase: Completed; Phase 4

Conditions: METABOLIC SYNDROME; HYPERTENSION; PRE-HYPERTENSION

Treatments: Drug: valsartan plus hydrochlorothiazide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00170937

CVAL489A2426

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind