Clinical trial NCT00208221: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hypertension
Type 2 Diabetes
Albuminuria
Keywords: Hypertension
Diabetes
Microalbuminuria
Blood pressure
Lead sponsor: Institut de Recherches Cliniques de Montreal
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

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.

Primary outcomes:
measure: Microalbuminuria
Secondary outcomes:
measure: Plasma renin
measure: plasma angiotensin
measure: plasma aldosterone
measure: plasma catecholamines
measure: oxydative stress
measure: diastolic blood pressure
measure: systolic blood pressure
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Institut de Recherches Cliniques de Montreal
state: Quebec
Study officials:
affiliation: Institut de Recherches Cliniques de Montreal
name: Pierre Larochelle, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: