Telmisartan |
Micardis |
Clinical Trial: Higher Dose of Ramipril Versus Addition of Telmisartan-Ramipril in Hypertension and Diabetes
This study is not yet open for patient recruitment.
Verified by Institut de Recherches Cliniques de Montreal July 2005
|
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Hypertension Type 2 Diabetes Microalbuminuria | Drug: ramipril Drug: ramipril-telmisartan | Phase III |
MedlinePlus related topics: Diabetes; High Blood Pressure
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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
Secondary Outcomes: Plasma Renin; Plasma angiotensin; plasma aldosterone; plasma catecholamines; oxydative stress; diastolic blood pressure; systolic blood pressure
Expected Total Enrollment: 50
Study start: October 2005; Expected completion: October 2007
Last follow-up: April 2007; Data entry closure: August 2007
To determine the effects of ramipril 10 mg+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
Eligibility
Inclusion Criteria:
Male or female over the age of 18 years Diastolic blood pressure greater tha 80 mmhg and less than 104 mmhg Type II diabetes on diet or oral hypoglycemic agents with an hbiAC 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 test.
Known or secondary forms of hypertension. Intolerance to AT 1 receptor blockers or ACE inhibitors. Hepatic or renal dysfunction. Creatinine>150 umol or enzymes greater the n 2 times upper limit of normal.
Hemodynamiclly 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 CHF III-IV. Coronary heart disease needing pharmacological therapy. Stroke within the preceeding six months. PTCA within the preceeding 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-blockerss, 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, 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 preceeding 1 month.
Location and Contact Information
Canada, Quebec
Institut de Recherches Cliniques de Montreal, Montreal, Quebec, J4X 1J3, Canada
Pierre Larochelle, MD,FRCPC,PhD, Principal Investigator
Pierre Larochelle, MD PhD FRCPC, Principal Investigator, Unaffiliated
More Information
Last Updated: September 20, 2005
Record first received: September 13, 2005
ClinicalTrials.gov Identifier: NCT00208221
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-09-27
Resources
- Micardis (Drug Digest)
- Micardis Consumer Information (U.S. Food and Drug Administration)

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