Clinical trial: Pleiotropic Effects of Azilsartan Medoxomil Over Insulin Resistance in Obese, Diabetic and Hypertensive Patients (NCT02235519)

Eligibility 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
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 25 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Contradiction