The primary objectives are to demonstrate that MICARDIS® (telmisartan) is statistically
superior to Diovan® (valsartan) in reducing diastolic blood pressure (DBP) following a missed
dose at the end of a 6 to 8-week treatment period as measured by the 24-hour ABPM mean and to
demonstrate that MICARDIS® is statistically superior to Diovan® in reducing DBP during the
last 6-hours of the 24-hour dosing interval as measured by ABPM following a dose of active
study medication at the end of a 6 to 8-week treatment period.
Inclusion Criteria:
Mild-to-moderate hypertension defined as a baseline mean seated DBP of greater than or
equal to 95 mm Hg and less than or equal to 109 mm Hg and a baseline 24-hour ABPM mean DBP
of greater than or equal to 85 mm Hg.
Exclusion Criteria:
1. Pre-menopausal women (last menstruation =1 year prior to signing informed consent)
who:
- are not surgically sterile;
- are nursing,
- are of child-bearing potential and are NOT practicing acceptable methods of birth
control, or do NOT plan to continue practicing an acceptable method throughout
the study. Acceptable methods of birth control include IUD, oral, implantable or
injectable contraceptives. No exceptions will be made.
2. Night shift workers who routinely sleep during the daytime and whose work hours
include midnight to 4: 00 A. M.
3. Mean sitting SBP =180 mm Hg or mean sitting DBP =110 mm Hg during any visit of the
placebo run-in period.
4. Known or suspected secondary hypertension (i. e., pheochromocytoma).
5. Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
- SGPT (ALT) or SGOT (AST) >2 times the upper limit of normal range,
- Serum creatinine >2. 3 mg/dL (or >203 µmol/l).
6. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney,
post-renal transplant patients or patients with only one kidney.
7. Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia.
8. Uncorrected volume depletion.
9. Primary aldosteronism.
10. Hereditary fructose intolerance.
11. Biliary obstructive disorders.
12. Congestive heart failure (NYHA functional class CHF III-IV).
13. Unstable angina within the past three months prior to signing the informed consent
form.
14. Stroke within the past six months prior to signing the informed consent form.
15. Myocardial infarction or cardiac surgery within the past three months prior to signing
the informed consent form.
16. PTCA (percutaneous transluminal coronary revascularization) within the past three
months prior to signing the informed consent form.
17. Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other
clinically relevant cardiac arrhythmias as determined by the investigator.
18. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant
stenosis of the aortic or mitral valve.
19. Patients with insulin-dependent diabetes mellitus whose diabetes has not been stable
and controlled for at least the past three months as defined by an HbA1C =10%.
20. Patients who have previously experienced symptoms characteristic of angioedema during
treatment with ACE inhibitors or angiotensin II receptor antagonists.
21. History of drug or alcohol dependency within 6 months prior to signing the informed
consent form.
22. Chronic administration of any medications known to affect blood pressure, except
medication allowed by the protocol.
23. Any investigational therapy within one month of signing the informed consent form.
24. Known hypersensitivity to any component of the formulations.
25. Any clinical condition which, in the opinion of the investigator would not allow safe
completion of the protocol and safe administration of trial medication.
26. Inability to comply with the protocol.
Heart Health Institute, Calgary, Alberta T2E 7C5, Canada
Memorial Research Medical Clinic, Long Beach, California 90806, United States
National Research Institute, Los Angeles, California 90057, United States
Orange County Research Center, Orange, California 92868, United States
University of Conn. Health Services Center, Hypertension and Vascular Disease, Farmington, Connecticut 06030, United States
Alan Graff, Fort Lauderdale, Florida 33308, United States
Orlando Clinical Research Center, Orlando, Florida 32806, United States
Greater Ft. Lauderdale Heart Group Research, Ft. Lauderdale, Florida 33308, United States
So. Clinical Research and Management, Inc., Augusta, Georgia 30904, United States
Rush Presbyterian/St. Luke's Medical Center, Chicago, Illinois 60612, United States
University of Maryland/Nephrology Clinical Research Unit, Baltimore, Maryland 21201, United States
Washington University, St. Louis, Missouri 63110, United States
Dr. Dennis O'Keefe, Mount Pearl, Newfoundland and Labrador A1N 2C3, Canada
Dr. William Booth, Antigonish, Nova Scotia B2G 2C2, Canada
MSHJ Research Assoc., Halifax, Nova Scotia B3K 5R3, Canada
Oklahoma Cardiovascular and Hypertension Center, Oklahoma City, Oklahoma 73132, United States
Dr. Joseph Berlingieri, Burlington, Ontario L7R 2H3, Canada
BBM Clinical Research Ltd., Courtice, Ontario L1E 3C3, Canada
Dr. William Mahoney, Corunna, Ontario N0N 1G0, Canada
Sunnybrook & Women's College Health Centre, Toronto, Ontario M4N 3M5, Canada
Dr. Richard Tytus, Hamilton, Ontario L8M 1K7, Canada
Centre for Activity and Aging, London, Ontario N6G 2M3, Canada
Total Concept Health Care, Kitchener, Ontario N2C 2N9, Canada
Dr. Martyn Chilvers, Sarnia, Ontario N7T 4X3, Canada
Michael A. Azorr, M.D., Portland, Oregon 97232, United States
Harleysville Medical Associates, Harleysville, Pennsylvania 19438, United States
Theradev Clinical Research, Inc., Granby, Quebec J2G 8Z9, Canada
Centre de Cardiologie, Saint Lambert, Quebec J4P 2H4, Canada
Centre Hospital Quebec - PAC CHUL Unite de Recherche, Sainte-Foy, Quebec G1V 4G2, Canada
Invascor, Longueuil, Longueuil, Quebec J4N 1E1, Canada
Q&T Research, Sherbrooke, Quebec J1H 4J6, Canada
Hotel Dieu de St-Jerome, Saint Jerome, Quebec J7Z 5T3, Canada
Royal University Hospital, Saskatoon, Saskatchewan S7N 0W8, Canada
Trinity Hypertension Research Institute/Punzi Medical Center, Carrollton, Texas 75006, United States
UW Health/Physicians Plus Center for Clinical Trials, Madison, Wisconsin 53715, United States
