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

Last updated: November 7, 2007
Sponsor: Institut de Recherches Cliniques de Montreal
Overall Status: Terminated

Phase

3

Condition

Vascular Diseases

Proteinuria

Stress

Treatment

N/A

Clinical Study ID

NCT00208221
RD 0507/17259
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • DBP > 104 mmhg

  • Woman not surgically sterile or menopausal.

  • Premenopausal women whoo are not surgically sterile or who are not practicingacceptable means of birth control and do not agree to submit to periodic pregnancytests.

  • 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 timesupper limit of normal.

  • Hemodynamically significant renal artery stenosis, renal artery stenosis on a solitarykidney, 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 threemonths.

  • History of angioedema.

  • Sustained ventricular tachycardia, atrial fibrillation, or other clinically relevantcardiac arrhythmias as determined by the clinical investigator.

  • Second or third degree AV block, left bundle branch block or any clinically relevantconduction abnormality as determined by the clinical investigator.

  • Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevantstenosis 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 IIantagonists, alpha-blockers, beta-blockers, calcium channel antagonists, directvasodilators that cannot be stopped for the trial.

  • Administration of other non-antihypertensive medications known to affect bloodpressure (e.g. oral corticosteroids, monoamine oxidase [MAO] inhibitors, nitrates) atany 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 lessthan 3.0 mEq/L.

  • Patients receiving any investigational therapy within one month of signing theinformed consent form.

  • Known hypersensitivity to any component of telmisartan, ramipril orhydrochlorothiazide.

  • Any other clinical condition which, in the opinion of the principal investigator,would not allow safe completion of the protocol and safe administration of trialmedication.

  • Blood donation in the preceding 1 month.

Study Design

Total Participants: 50
Study Start date:
August 01, 2006
Estimated Completion Date:
June 30, 2007

Study Description

The purpose of this study is to determine the effects of ramipril 10 mg and telmisartan 80 mg versus ramipril 20 mg in patients with diabetes type II, hypertension and microalbuminuria (Urinary-albuminuria creatinine ratio of 2.0 to 25 mg/mmol) on

  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

Connect with a study center

  • Institut de Recherches Cliniques de Montreal

    Montreal, Quebec J4X 1J3
    Canada

    Site Not Available

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