GoldBamboo.com - Knowledge is strong medicine
  

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


  Not Signed In - Sign In / Register






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

Sponsored by: Institut de Recherches Cliniques de Montreal
Information provided by: Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov Identifier: NCT00208221

Purpose

To determine if a dose of ramopril 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
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

Further Study Details: 
Primary Outcomes: Microalbuminuria
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

  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

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both
Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00208221

Pierre Larochelle, MD PhD FRCPC      514-987-5549    larochp@ircm.qc.ca

Canada, Quebec
      Institut de Recherches Cliniques de Montreal, Montreal,  Quebec,  J4X 1J3,  Canada
Joanie Houle, R.N.  514-987-5567    houlej@ircm.qc.ca 
Pierre Larochelle, MD,FRCPC,PhD,  Principal Investigator

Study chairs or principal investigators

Pierre Larochelle, MD PhD FRCPC,  Principal Investigator,  Unaffiliated   

More Information

Study ID Numbers:  RD 0507/17259
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



Take control over your directory listings...INSTANTLY

Every day, thousands of users find businesses like yours in the GoldBamboo directory.

Limited Time Offer!!!

For only $50 a year, a savings of 50% off our standard rate:

  • Edit your listing (whenever you want!)
  • Link to your website
  • Choose which categories you are listed in
  • Describe your services

The process will take only a few minutes and consists of 3 easy steps:

1. Register     >     2. Edit Listings     >     3. Publish

Your Company
your street
yourtown, YS 12345
888-888-8888



No Thanks

Popular Treatments

Acne Treatment ADHD Treatment Allergy Treatment Alzheimer's Treatment
Anemia Treatment Arthritis Treatment Asthma Treatment Bipolar Disorder Treatment
Bird Flu Treatment Bladder Cancer Treatment Bladder Control Treatment Blood Pressure Treatment
Brain Tumor Treatment Breast Cancer Treatment Bronchitis Treatment Cancer Treatment
Cancer Alternative Treatment Cataract Treatment Cirrhosis Treatment Colitis Treatment
Colon Cancer Treatment Common Cold Treatment Conjunctivitis Treatment Constipation Treatment
Crohn's Disease Treatment Cystic Fibrosis Treatment Depression Treatment Dermatitis Treatment
Diabetes Treatment Edema Treatment Epilepsy Treatment Erectile Dysfunction Treatment
Fibromyalgia Treatment GERD Treatment Glaucoma Treatment Gout Treatment
Hay Fever Treatment Headache Treatment Heart Disease Treatment Hepatitis Treatment
High Blood Pressure Treatment High Cholesterol Treatment Hives Treatment Hypertension Treatment
Hypoglycemia Treatment IBS Treatment Impotence Treatment Indigestion Treatment
Infertility Treatment Influenza Treatment Insomnia Treatment Lactose Intolerance Treatment
Leukemia Treatment Lung Cancer Treatment Lyme Disease Treatment Macular Degeneration Treatment
Menopause Treatment Migraine Treatment Osteoarthritis Treatment Osteoporosis Treatment
Pancreatic Cancer Treatment PMS Treatment Pneumonia Treatment Prostate Diseases Treatment
Restless Leg Treatment Rheumatoid Arthritis Treatment Sepsis Treatment Sinusitis Treatment
Skin Cancer Treatment Sleep Apnea Treatment Snoring Treatment Stroke Treatment
Testicular Cancer Treatment
GoldBambooTM

Your Integrative Health and Wellness Resource for Telmisartan.

November 18, 2008



Page Updated: September 6, 2005
============== Advertisement ==============
Disclaimer: All material displayed on the GoldBamboo.com website is provided for educational purposes only. Consult a physician regarding the applicability of any information found on GoldBamboo.com to your symptoms or medical condition.

Home | About Us | Link To Us | Feedback | Disclaimer | Privacy Policy | Terms of Use | Google Co-op | Health Forums

Copyright © 2004-2008 - Gold Bamboo LLC
All rights reserved.

HONcode accreditation seal.

We comply with the HONcode standard for health trust worthy information:
verify here.