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.

Condition	Treatment or Intervention	Phase
Hypertension	Drug: telmisartan, valsartan	Phase IV

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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.

California
      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
Connecticut
      University of Conn. Health Services Center, Hypertension and Vascular Disease, Farmington,  Connecticut,  06030,  United States
Florida
      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
Georgia
      So. Clinical Research and Management, Inc., Augusta,  Georgia,  30904,  United States
Illinois
      Rush Presbyterian/St. Luke's Medical Center, Chicago,  Illinois,  60612,  United States
Maryland
      University of Maryland/Nephrology Clinical Research Unit, Baltimore,  Maryland,  21201,  United States
Missouri
      Washington University, St. Louis,  Missouri,  63110,  United States
Oklahoma
      Oklahoma Cardiovascular and Hypertension Center, Oklahoma City,  Oklahoma,  73132,  United States
Oregon
      Michael A. Azorr, M.D., Portland,  Oregon,  97232,  United States
Pennsylvania
      Harleysville Medical Associates, Harleysville,  Pennsylvania,  19438,  United States
Texas
      Trinity Hypertension Research Institute/Punzi Medical Center, Carrollton,  Texas,  75006,  United States
Wisconsin
      UW Health/Physicians Plus Center for Clinical Trials, Madison,  Wisconsin,  53715,  United States
Canada, Alberta
      Heart Health Institute, Calgary,  Alberta,  T2E 7C5,  Canada
Canada, Newfoundland and Labrador
      Dr. Dennis O'Keefe, Mount Pearl,  Newfoundland and Labrador,  A1N 2C3,  Canada
Canada, Nova Scotia
      Dr. William Booth, Antigonish,  Nova Scotia,  B2G 2C2,  Canada
      MSHJ Research Assoc., Halifax,  Nova Scotia,  B3K 5R3,  Canada
Canada, Ontario
      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
Canada, Quebec
      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
Canada, Saskatchewan
      Royal University Hospital, Saskatoon,  Saskatchewan,  S7N 0W8,  Canada

Study ID Numbers:  BI 502.327
Record last reviewed:  November 2002
Last Updated:  October 13, 2004
Record first received:  May 2, 2002
ClinicalTrials.gov Identifier:  NCT00034840
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08