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

This study has been terminated.
(Not enough recruitment)
Sponsor:
Information provided by:
Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov Identifier:
NCT00208221
First received: September 13, 2005
Last updated: November 7, 2007
Last verified: November 2007
  Purpose

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.


Condition Intervention Phase
Hypertension
Type 2 Diabetes
Albuminuria
Drug: ramipril
Drug: ramipril-telmisartan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Institut de Recherches Cliniques de Montreal:

Primary Outcome Measures:
  • Microalbuminuria

Secondary Outcome Measures:
  • Plasma renin
  • plasma angiotensin
  • plasma aldosterone
  • plasma catecholamines
  • oxydative stress
  • diastolic blood pressure
  • systolic blood pressure

Estimated Enrollment: 50
Study Start Date: August 2006
Study Completion Date: June 2007
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208221

Locations
Canada, Quebec
Institut de Recherches Cliniques de Montreal
Montreal, Quebec, Canada, J4X 1J3
Sponsors and Collaborators
Institut de Recherches Cliniques de Montreal
Investigators
Principal Investigator: Pierre Larochelle, MD PhD FRCPC Institut de Recherches Cliniques de Montreal
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00208221     History of Changes
Other Study ID Numbers: RD 0507/17259
Study First Received: September 13, 2005
Last Updated: November 7, 2007
Health Authority: Canada: Health Canada

Keywords provided by Institut de Recherches Cliniques de Montreal:
Hypertension
Diabetes
Microalbuminuria
Blood pressure

Additional relevant MeSH terms:
Hypertension
Diabetes Mellitus, Type 2
Diabetes Mellitus
Albuminuria
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Ramipril
Telmisartan
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on October 01, 2014