Higher Dose of Ramipril Versus Addition of Telmisartan-Ramipril in Hypertension and Diabetes

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.