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

• Status: Terminated
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut de Recherches Cliniques de Montreal
• Treatments: Ramipril; Telmisartan

Criteria

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.