Pleiotropic Effects of Azilsartan Medoxomil Over Insulin Resistance in Obese, Diabetic and Hypertensive Patients

• Status: Unknown status
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hospital General de México Dr. Eduardo Liceaga
• Treatments: Azilsartan medoxomil

Criteria

Inclusion Criteria:

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

2. Age between ≥25 and ≤ 65 years

3. 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

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

5. BMI ≥25 and ≤35.

6. Patients with type 2 diabetes mellitus can participate and will be stratified before randomization. Diagnosis can be established by clinical history, 75-g oral glucose tolerance test (ADA criteria), or fasting glucose > 126 mg/dL.

Exclusion Criteria:

1. 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.

2. Known hypersensitivity to the study drug

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

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

5. Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.

6. Known or suspected secondary hypertension (e.g., renal artery stenosis or phaeochromocytoma)

7. SBP≥160 mmHg and/or DBP ≥100 mmHg

8. Renal dysfunction as defined by: serum creatinine >3.0 mg/dL (or >265 umol/L) and/or creatinine clearance <30 ml/min and/or other clinical markers of severe renal impairment.

9. Bilateral renal arterial stenosis, renal artery stenosis in a solitary functional kidney, post-renal transplant patients or patients with one kidney

10. Clinically relevant hypokalemia or hyperkalemia (i.e., <3.5 mmol/L or >5.5 mmol/L, may be rechecked for suspected error in result)

11. Uncorrected sodium or volume depletion

12. Primary aldosteronism.

13. Hereditary fructose intolerance

14. Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency

15. Congestive heart failure class III-IV according to criteria fron the New York Heart Association.

16. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator.

17. Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve

18. Patients whose diabetes has not been stable and controlled for at least the past 3 months as defined by an Glycosylated Hemoglobin A1c >=10% or fasting glucose greater than 400 mg/dL.

19. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists

20. History of drug or alcohol dependency within 6 months prior to signing the informed consent form

21. Concomitant administration of any medications known to affect blood pressure, except medications allowed by the protocol

22. Any investigational drug therapy within 1 month of signing the informed consent

23. Known hypersensitivity to any component of the trial drugs (telmisartan, hydrochlorothiazide, or placebo)

24. History of non-compliance or inability to comply with prescribed medications or protocol procedures (less than 80% or more than 120%, especially during run-in).

25. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication