Who is sponsoring NCT02235519?

NCT02235519 is sponsored by Hospital General de México Dr. Eduardo Liceaga.

What condition does NCT02235519 study?

NCT02235519 studies Hypertension, Obesity, Type 2 Diabetes Mellitus.

What drugs are being tested in NCT02235519?

Interventions: Azilsartan 40 mg., Azilsartan 80 mg.

What is the status of NCT02235519?

NCT02235519 is currently UNKNOWN.

Last reviewed 2015-03-27 · How we verify

A Randomized, Open Label Study to Evaluate the Pleiotropic Effects of Azilsartan Medoxomil 40 and 80 mg for 12 Weeks Over Metabolic Markers in Patients With Hypertension, Obesity or Type 2 Diabetes Mellitus

NCT02235519 Phase 2/Phase 3 UNKNOWN

The goal of this study is to build a mathematical model to explain the effect of two doses of azilsartan (40 and 80 mg) upon metabolic (insulin resistance, glucose) and inflammatory parameters (cytokines) in function of "metabolic strata" like obesity, type 2 diabetes mellitus, hypertension and their combinations.

Details

Lead sponsor	Hospital General de México Dr. Eduardo Liceaga
Phase	Phase 2/Phase 3
Status	UNKNOWN
Enrolment	300
Start date	2014-01
Completion	2015-06

Conditions

Hypertension
Obesity
Type 2 Diabetes Mellitus

Interventions

Azilsartan 40 mg.
Azilsartan 80 mg

Primary outcomes

Blood pressure — 12 weeks
Effect size of azilsartan medoxomil 40 and 80 mg in lowering systolic and diastolic blood pressure stratified by metabolic condition (obesity or type 2 diabetes mellitus). The minimal size effect between groups will be at least 30% and absolute percentage of previous hypertensive subjects reaching targeted values of \< 130/85 mmHg.

Countries

Mexico