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

Phase 4

Completed

• Conditions: METABOLIC SYNDROME; PRE-HYPERTENSION; HYPERTENSION

• Registration Number: NCT00170937
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-09-10
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-15
• Primary Completion: 2006-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 507

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in insulin sensitivity after 16 weeks

Secondary Outcome Measures

Name	Time	Method
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 markers of inflammation and thrombosis 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

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇺🇸 E. Hanover, New Jersey, United States