Suspended

Azilsartan Medoxomil Effects on Metabolic Markers in Hypertensive, Obese, or Type 2 Diabetes Patients

Study Aim

This study aims to evaluate the effectiveness of Azilsartan Medoxomil in lowering blood pressure in hypertensive individuals who are either obese or have type 2 diabetes, focusing on reaching targeted values of less than 130/85 mmHg.

What is being tested

Azilsartan 40 mg.

+ Azilsartan 80 mg

Drug

Who is being recruted

Body Weight+13

+ Cardiovascular Diseases

+ Diabetes Mellitus

From 25 to 65 Years

+31 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2 & 3

Interventional

Study Start: January 2014

See protocol details

Summary

Principal SponsorHospital General de México Dr. Eduardo Liceaga

Study ContactAntonio Peralta, MD

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2014

Actual date on which the first participant was enrolled.

This study seeks to understand the impact of a drug called Azilsartan Medoxomil on patients with conditions like hypertension, obesity, or type 2 diabetes. Azilsartan is a medication that has shown potential in improving metabolic conditions, not just controlling blood pressure. The study aims to create a mathematical model to analyze the effects of Azilsartan on metabolic and inflammatory measurements in patients with different combinations of these conditions. Patients will be divided into groups based on their metabolic status and will receive either 40 or 80 mg of Azilsartan for 12 weeks. The study will take place at the Hospital General de Mexico, and participants will be asked to attend several visits for physical examinations, blood tests, and monitoring of adverse events. The main goal is to see how well Azilsartan helps lower blood pressure and improve metabolic control in these patients, with a focus on those with a combination of obesity, hypertension, and type 2 diabetes.

Official TitleA 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

Principal SponsorHospital General de México Dr. Eduardo Liceaga

Study ContactAntonio Peralta, MD

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 25 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightCardiovascular DiseasesDiabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesHypertensionMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesOvernutritionGlucose Metabolism DisordersOverweight

Criteria

6 inclusion criteria required to participate

Written informed consent in accordance with Good Clinical Practices and local legislations

Age between ≥25 and ≤ 65 years

Patients with hypertension stage 1 as defined by systolic blood pressure (SBP) ≥140 but <159 mmHg and diastolic blood pressure (DBP) ≥90 but < 99 mmHg at randomization

Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator's discretion)

Show More Criteria

25 exclusion criteria prevent from participating

Pre-menopausal women (last menstruation ≤1 year prior to signing informed consent) who are not surgically sterile, nursing, are pregnant or without any anticonceptive methods.

Known hypersensitivity to the study drug

Gastrointestinal surgery which might alter absorption, distribution, or drug metabolism.

History of angioedema related to ACE inhibitors or angiotensin II receptor blockers.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

Patients will take azilsartan 40 mg during 12 weeks

Group II

Active Comparator

Patients will take azilsartan 80 mg during 12 weeks

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Hospital General de Mexico "Dr. Eduardo Liceaga"

Mexico City, MexicoOpen Hospital General de Mexico "Dr. Eduardo Liceaga" in Google Maps

SuspendedOne Study Center