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

Comparison of a Higher Dose of Ramipril to the Addition of Telmisartan 80 mg+Ramipril 10 mg in Patients With Hypertension and Diabetes

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.

Study Overview

• Status: Terminated
• Conditions: Hypertension; Type 2 Diabetes; Albuminuria
• Intervention / Treatment: Drug: ramipril; Drug: ramipril-telmisartan

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, J4X 1J3
      • Institut de Recherches Cliniques de Montreal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Microalbuminuria

Secondary Outcome Measures

Outcome Measure
systolic blood pressure
diastolic blood pressure
Plasma renin
plasma angiotensin
plasma aldosterone
plasma catecholamines
oxydative stress

Collaborators and Investigators

• Sponsor: Institut de Recherches Cliniques de Montreal
• Investigators: Principal Investigator: Pierre Larochelle, MD PhD FRCPC, Institut de Recherches Cliniques de Montreal

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): November 8, 2007
• Last Update Submitted That Met QC Criteria: November 7, 2007
• Last Verified: November 1, 2007

More Information

Terms related to this study

• Keywords: Diabetes; Hypertension; Blood pressure; Microalbuminuria
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Urologic Diseases; Urological Manifestations; Endocrine System Diseases; Urination Disorders; Proteinuria; Hypertension; Diabetes Mellitus; Albuminuria; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Telmisartan; Ramipril
• Other Study ID Numbers: RD 0507/17259