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.
2. Blood pressure (systolic, diastolic and ABPM), Renin-angiotensin system, Catecholamines,
3. Comparison at 4, 8 and 12 weeks with addition of hydrochlorothiazide 12. 5 mg if BP over
Minimum age: 18 Years.
Maximum age: 80 Years.
- 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
- 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
- Known or secondary forms of hypertension.
- Intolerance to angiotensin (AT) 1 receptor blockers or angiotensin-converting enzyme
- 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
- 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
- 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
- Blood donation in the preceding 1 month.