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

Primary Purpose

Hypertension, Type 2 Diabetes, Albuminuria

Status
Terminated
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
ramipril
ramipril-telmisartan
Sponsored by
Institut de Recherches Cliniques de Montreal
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Diabetes, Microalbuminuria, Blood pressure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institut de Recherches Cliniques de Montreal

Outcomes

Primary Outcome Measures

Microalbuminuria

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2005
Last Updated
November 7, 2007
Sponsor
Institut de Recherches Cliniques de Montreal
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1. Study Identification

Unique Protocol Identification Number
NCT00208221
Brief Title
Higher Dose of Ramipril Versus Addition of Telmisartan-Ramipril in Hypertension and Diabetes
Official Title
Comparison of a Higher Dose of Ramipril to the Addition of Telmisartan 80 mg+Ramipril 10 mg in Patients With Hypertension and Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Terminated
Why Stopped
Not enough recruitment
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Institut de Recherches Cliniques de Montreal

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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 Microalbuminuria Blood pressure (systolic, diastolic and ABPM), Renin-angiotensin system, Catecholamines, Oxydative stress Comparison at 4, 8 and 12 weeks with addition of hydrochlorothiazide 12.5 mg if BP over 130/80 mmHg

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Type 2 Diabetes, Albuminuria
Keywords
Hypertension, Diabetes, Microalbuminuria, Blood pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ramipril
Intervention Type
Drug
Intervention Name(s)
ramipril-telmisartan
Primary Outcome Measure Information:
Title
Microalbuminuria
Secondary Outcome Measure Information:
Title
Plasma renin
Title
plasma angiotensin
Title
plasma aldosterone
Title
plasma catecholamines
Title
oxydative stress
Title
diastolic blood pressure
Title
systolic blood pressure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Larochelle, MD PhD FRCPC
Organizational Affiliation
Institut de Recherches Cliniques de Montreal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Recherches Cliniques de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
J4X 1J3
Country
Canada

12. IPD Sharing Statement

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

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