The purpose of this study is to determine if a dose of ramipril combined with a normal dose
of telmisartan 80 mg will be more effective than ramipril 20 mg in reducing microalbuminuria
in hypertensive patients with diabetes.
1. Microalbuminuria
2. Blood pressure (systolic, diastolic and ABPM), Renin-angiotensin system, Catecholamines,
Oxydative stress
3. Comparison at 4, 8 and 12 weeks with addition of hydrochlorothiazide 12. 5 mg if BP over
130/80 mmHg
Inclusion Criteria:
- Male or female over the age of 18 years
- Diastolic blood pressure (DBP) greater tha 80 mmHg and less than 104 mmHg
- Type II diabetes on diet or oral hypoglycemic agents with a hemoglobin A1C (HbA1C)
less than 0. 080
- UA ratio albumin: creatinine 2. 0 to 25 mg/mmol
Exclusion Criteria:
- DBP > 104 mmhg
- Woman not surgically sterile or menopausal.
- Premenopausal women whoo are not surgically sterile or who are not practicing
acceptable means of birth control and do not agree to submit to periodic pregnancy
tests.
- Known or secondary forms of hypertension.
- Intolerance to angiotensin (AT) 1 receptor blockers or angiotensin-converting enzyme
(ACE) inhibitors.
- Hepatic or renal dysfunction. Creatinine > 150 umol or enzymes greater than 2 times
upper limit of normal.
- Hemodynamically significant renal artery stenosis, renal artery stenosis on a solitary
kidney, post-renal transplant or with only one kidney.
- Uncorrected volume depletion.
- Biliary obstructive disorders.
- NYHA functional class congestive heart failure (CHF) III-IV.
- Coronary heart disease needing pharmacological therapy.
- Stroke within the preceding six months.
- Percutaneous transluminal coronary angioplasty (PTCA) within the preceding three
months.
- History of angioedema.
- Sustained ventricular tachycardia, atrial fibrillation, or other clinically relevant
cardiac arrhythmias as determined by the clinical investigator.
- Second or third degree AV block, left bundle branch block or any clinically relevant
conduction abnormality as determined by the clinical investigator.
- Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant
stenosis of aortic or mitral valve.
- Administration of digoxin.
- Patients with a fasting glucose greater than 7. 0
- History of drug or alcohol dependency.
- Use of antihypertensive agents such as diuretics, ACE inhibitors, angiotensin II
antagonists, alpha-blockers, beta-blockers, calcium channel antagonists, direct
vasodilators that cannot be stopped for the trial.
- Administration of other non-antihypertensive medications known to affect blood
pressure (e. g. oral corticosteroids, monoamine oxidase [MAO] inhibitors, nitrates) at
any time during the trial.
- Chronic use of salt substitutes containing potassium chloride; potassium supplements;
extreme dietary restrictions.
- Uncorrected sodium depletion as defined by a serum sodium level less than 135 mEq/L.
- Clinically significant hyperkalemia as defined by serum potassium level greater than
5. 2 mEq/L. Clinically significant hypokalemia as defined by serum potassium level
less than 3. 0 mEq/L.
- Patients receiving any investigational therapy within one month of signing the
informed consent form.
- Known hypersensitivity to any component of telmisartan, ramipril or
hydrochlorothiazide.
- Any other clinical condition which, in the opinion of the principal investigator,
would not allow safe completion of the protocol and safe administration of trial
medication.
- Blood donation in the preceding 1 month.
