The primary objective of this study is to compare the effectiveness of telmisartan 80 mg /
hydrochlorothiazide 25 mg [Micardis HCT] to valsartan 160 mg / hydrochlorothiazide 25 mg
[Diovan HCT] and placebo in the treatment of Stage 1 and Stage 2 hypertension.
Inclusion criteria
1. Ability to provide written informed consent.
2. Age 18 years or older
3. Ability to stop current antihypertensive therapy without unacceptable risk to the
patient (investigator's discretion)
4. Seated cuff DBP of 95 mmHg at Visit 2 (baseline)
Exclusion criteria
1. Pre-menopausal women (last menstruation 1 year prior to start of run-in period) who:
1. are not surgically sterile; and/or
2. are nursing or pregnant
3. are of child-bearing potential and are NOT practicing acceptable means of birth
control, do NOT plan to continue using this method throughout the study and do
NOT agree to submit to periodic pregnancy testing during participation in studies
of > 3-months duration. Acceptable methods of birth control include oral,
implantable, transdermal, or injectable contraceptives, and Intra-Uterine Device
(IUD).
2. Known or suspected secondary hypertension.
3. Mean seated SBP >= 180 mmHg or mean seated DBP >= 120 mmHg during any clinic visit
prior to randomization.
4. Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
1. SGPT (ALT) or SGOT (AST) > 2 times the upper limit of normal range, or
2. Serum creatinine > 3. 0 mg/dL or creatinine clearance < 0. 6 ml/sec.
5. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney,
post-renal transplant or with only one kidney.
6. Clinically relevant hypokalemia or hyperkalemia.
7. Uncorrected volume depletion.
8. Uncorrected sodium depletion.
9. Primary aldosteronism.
10. Hereditary fructose intolerance.
11. Biliary obstructive disorders, cholestatis or moderate to severe hepatic
insufficiency.
12. Patients who have previously experienced symptoms characteristic of angioedema during
treatment with ACE inhibitors or angiotensin II receptor antagonists.
13. History of drug or alcohol dependency within six months prior to start of run-in
period.
14. Chronic administration of any medications known to affect blood pressure, exc
15. Any investigational drug therapy within one month of start of run-in period
16. known hypersensitivity to any component of the formulation study drugs (telmisartan,
valsartan, HCT)
17. Contra-indication to a placebo run-in period (e. g. stroke within the past six months,
MI, cardia surgery, PTCA or angina within the past three months prior to the start of
run-in period.
18. Any other clinical condition which, in the opinion of the principal investigator,
would not allow safe completion of the protocol and safe administration of telmisarta,
valsartan, or HCT.
19. Night shift workers
20. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or
other clinically relevant cardiac arrhythmias as determined by the investigator.
21. NYHA functional class CHF III-IV
22. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant
stenosis of aortic or mitral valve.
23. Patients whose diabetes has been unstable and uncoltrolled for at least the past 3
months as defined by a HbA1c >/= 10%.
24. Concomitant use of lithium or cholestryramine or colestipol resins (potential drug
interactions with HCT.)
25. History of non-compliance with prescribed medication or protocol procedures.
Boehringer Ingelheim Investigational Site, Huntsville, Alabama, United States
Boehringer Ingelheim Investigational Site, Mobile, Alabama, United States
Boehringer Ingelheim Investigational Site, Birmingham, Alabama, United States
Boehringer Ingelheim Investigational Site, Tucson, Arizona, United States
Boehringer Ingelheim Investigational Site, Sctoosdale, Arizona, United States
Boehringer Ingelheim Investigational Site, Hot Springs, Arkansas, United States
Boehringer Ingelheim Investigational Site, Carlisle, Arkansas, United States
Boehringer Ingelheim Investigational Site, Bentonville, Arkansas, United States
Boehringer Ingelheim Investigational Site, Concord, California, United States
Boehringer Ingelheim Investigational Site, San Leandro, California, United States
Boehringer Ingelheim Investigational Site, Sepulveda, California, United States
Memorial Research Medical Clinic, Long Beach, California, United States
Boehringer Ingelheim Investigational Site, Riverside, California, United States
Boehringer Ingelheim Investigational Site, Sacramento, California, United States
Boehringer Ingelheim Investigational Site, Orange, California, United States
Clinical Trials Research, Roseville, California, United States
Boehringer Ingelheim Investigational Site, Santa Ana, California, United States
Boehringer Ingelheim Investigational Site, Torrance, California, United States
Boehringer Ingelheim Investigational Site, Spring Valley, California, United States
Boehringer Ingelheim Investigational Site, Boulder, Colorado, United States
Boehringer Ingelheim Investigational Site, Farmington, Connecticut, United States
Clinical Research Consultants, Inc., Trumbull, Connecticut, United States
Boehringer Ingelheim Investigational Site, Bridgeport, Connecticut, United States
Boehringer Ingelheim Investigational Site, Waterbury, Connecticut, United States
Boehringer Ingelheim Investigational Site, Newark, Delaware, United States
Christopher Chappel, MD, Kissimmee, Florida, United States
Attention: Larry I. Gilderman, D.O., Pembroke Pines, Florida, United States
Boehringer Ingelheim Investigational Site, Holiday, Florida, United States
Boehringer Ingelheim Investigational Site, Panama City, Florida, United States
Boehringer Ingelheim Investigational Site, Ft. Myers, Florida, United States
Boehringer Ingelheim Investigational Site, Pembroke Pines, Florida, United States
Boehringer Ingelheim Investigational Site, Largo, Florida, United States
Boehringer Ingelheim Investigational Site, Palm Harbor, Florida, United States
Boehringer Ingelheim Investigational Site, Coral Gables, Florida, United States
Orlando Clinical Research Center, Orlando, Florida, United States
Boehringer Ingelheim Investigational Site, Hollywood, Florida, United States
Boehringer Ingelheim Investigational Site, Ft. Lauderdale, Florida, United States
Boehringer Ingelheim Investigational Site, Conyers, Georgia, United States
Boehringer Ingelheim Investigational Site, Atlanta, Georgia, United States
Grady Memorial Hospital, Atlanta, Georgia, United States
Treasure Valley Cardiology, Boise, Idaho, United States
N Touch Research, Peoria, Illinois, United States
Boehringer Ingelheim Investigational Site, Chicago, Illinois, United States
Herron Medical Center, Ltd., Chicago, Illinois, United States
Boehringer Ingelheim Investigational Site, Orland Park, Illinois, United States
Cedar-Crosse Research Center, Chicago, Illinois, United States
Midwest Institute for Clinical Research Inc., Indianapolis, Indiana, United States
Boehringer Ingelheim Investigational Site, Waterloo, Iowa, United States
Boehringer Ingelheim Investigational Site, Shawnee, Kansas, United States
Boehringer Ingelheim Investigational Site, Wichita, Kansas, United States
Boehringer Ingelheim Investigational Site, Louisville, Kentucky, United States
Attn:William Smith, New Orleans, Louisiana, United States
Boehringer Ingelheim Investigational Site, Baltimore, Maryland, United States
Waltham Hospital, Waltham, Massachusetts, United States
Boehringer Ingelheim Investigational Site, Brookline, Massachusetts, United States
Boehringer Ingelheim Investigational Site, Troy, Michigan, United States
Boehringer Ingelheim Investigational Site, Brooklyn Center, Minnesota, United States
Radiant Research, Edina, Minnesota, United States
Boehringer Ingelheim Investigational Site, Jackson, Mississippi, United States
Boehringer Ingelheim Investigational Site, Kansas City, Missouri, United States
Department of Medicine, Camden, New Jersey, United States
Boehringer Ingelheim Investigational Site, Cherry Hill, New Jersey, United States
Boehringer Ingelheim Investigational Site, Bronx, New York, United States
Northport VAMC - Medical Service (111), Northport, New York, United States
Boehringer Ingelheim Investigational Site, Kingston, New York, United States
Boehringer Ingelheim Investigational Site, Rochester, New York, United States
Boehringer Ingelheim Investigational Site, Scarsdale, New York, United States
Boehringer Ingelheim Investigational Site, Durham, North Carolina, United States
Boehringer Ingelheim Investigational Site, Winston-Salem, North Carolina, United States
Boehringer Ingelheim Investigational Site, Cary, North Carolina, United States
Boehringer Ingelheim Investigational Site, Raleigh, North Carolina, United States
Boehringer Ingelheim Investigational Site, Burlington, North Carolina, United States
Boehringer Ingelheim Investigational Site, Stateville, North Carolina, United States
Ohio State University, Columbus, Ohio, United States
Boehringer Ingelheim Investigational Site, Columbus, Ohio, United States
Boehringer Ingelheim Investigational Site, Mogadore, Ohio, United States
Radiant Reseach, Cincinnati, Ohio, United States
Radiant Research, Columbus, Ohio, United States
Boehringer Ingelheim Investigational Site, Mansfield, Ohio, United States
Boehringer Ingelheim Investigational Site, Cincinnati, Ohio, United States
Boehringer Ingelheim Investigational Site, Oklahoma City, Oklahoma, United States
Boehringer Ingelheim Investigational Site, Tulsa, Oklahoma, United States
Boehringer Ingelheim Investigational Site, Pottstown, Pennsylvania, United States
Boehringer Ingelheim Investigational Site, Philadelphia, Pennsylvania, United States
Bock Clinical Research, Collegeville, Pennsylvania, United States
Boehringer Ingelheim Investigational Site, East Providence, Rhode Island, United States
Boehringer Ingelheim Investigational Site, Greer, South Carolina, United States
Boehringer Ingelheim Investigational Site, Nashville, Tennessee, United States
Boehringer Ingelheim Investigational Site, Dallas, Texas, United States
Boehringer Ingelheim Investigational Site, Houston, Texas, United States
Boehringer Ingelheim Investigational Site, Austin, Texas, United States
Boehringer Ingelheim Investigational Site, McKinney, Texas, United States
Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States
Boehringer Ingelheim Investigational Site, Carrollton, Texas, United States
Boehringer Ingelheim Investigational Site, Salt Lake City, Utah, United States
Clinical Research Center of N. VA, Falls Church, Virginia, United States
Boehringer Ingelheim Investigational Site, Lacey, Washington, United States
Boehringer Ingelheim Investigational Site, Lakewood, Washington, United States
Boehringer Ingelheim Investigational Site, Madison, Wisconsin, United States
Boehringer Ingelheim Investigational Site, Milwaukee, Wisconsin, United States
