drugset / Trial / NCT00170937

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

NCT00170937 ↗

Phase 4 Completed 507 enrolled Novartis
RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2004-11
Primary completion
2006-03
Completion
—

Outcome

Missed primary endpoint

paper At the end point, there were no statistically significant differences in HOMA-IR among the 3 groups. PMID 19120715 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydrochlorothiazide Unknown 25 mg —
Subject Valsartan Unknown 320 mg —