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
Sponsor study identifier
interventional
300
1 country
1
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
September 5, 2014
Actual (reported)September 10, 2014
Actual (reported)June 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Blood pressure
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.
12 weeks
Insulin sensitivity and HbA1c level
12 weeks
Effect of azilsartan on Inflammatory markers
12 weeks
Endothelial function
12 weeks
Renal function improvement.
12 weeks
Patients will take azilsartan 40 mg during 12 weeks
Patients will take azilsartan 80 mg during 12 weeks
Patients will take 40 mg of azilsartan during 12 weeks
Patients will take 80 mg of azilsartan during 12 weeks
Hospital General de Mexico "Dr. Eduardo Liceaga"
Mexico City, Mexico City, 06720, Mexico
Antonio Peralta, MD
HGM
Rogelio Zapata, MD
HGM
Estrella Martinez, RN
HGM
First Submitted
September 5, 2014
First Posted
September 10, 2014
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2015
Estimated (date passed)Improving Diabetes Through Lifestyle and Surgery
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 30, 2015
Record last verified: 2014-09
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Source: ClinicalTrials.gov.
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