PROBE Parallel 6-week Treatment Comparing Telmisartan/Hydrochlorothiazide (HCT) (40/12.5 or 80/12.5) With Losartan/HCT (50/12.5) Using Ambulatory Blood Pressure Monitoring (ABPM)
NCT ID: NCT00274638
Last Updated: 2013-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
805 participants
INTERVENTIONAL
2002-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Telmisartan & Hydrochlorothiazide
Losartan & Hydrochlorothiazide
ABPM
Eligibility Criteria
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Inclusion Criteria
2. Mild-to-moderate hypertension defined as a mean seated DBP of \>= 95 mm Hg and \<=l to 109 mm Hg, measured by manual cuff sphygmomanometer at Visit 2.
3. Male or Female \>= 18 years.
4. Ability to stop any current antihypertensive therapy without risk to the patient (investigator's discretion).
5. 24-hour ABPM mean DBP of \>= 85 mm Hg at Visit 3.
Exclusion Criteria
* are not surgically sterile, or are
* nursing, or
* 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 exception 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 seated SBP \>= 180 mm Hg or mean seated DBP \>= 110 mm Hg during any visit or the placebo run-in phase.
4. Known or suspected secondary hypertension (i.e. pheochromocytoma).
5. Hepatic and/or renal dysfunction as defined by the following laboratory parameters: a)SGPT (ALT) or (SGOT) AST less than two times the upper limit of normal range, or b)Serum creatinine greater than 2.3 mg/dL (\>203 mico mol/l).
6. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
7. Biliary obstructive disorders.
8. Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia.
9. Uncorrected volume depletion.
10. Primary aldosteronism.
11. Hereditary fructose intolerance.
12. Congestive heart failure (NYHA functional class CHF III-IV).
13. Unstable angina within the past 3 months prior to signing the informed consent form.
14. Stroke within the past 6 months prior to signing the informed consent form.
15. Myocardial infarction or cardiac surgery within the past 3 months prior to signing the inform consent form.
16. PTCA (percutaneous transluminal coronary angioplasty) within the past 3 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 3 months as defined by an HbA1C \>= 10 Percent.
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 1 month of signing the informed consent form.
24. Known hypersensitivity to any component of the study drugs (placebo, telmisartan, hydrochlorothiazide or losartan).
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. Concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with hydrochlorothiazide).
27. History of non-compliance with prescribed medication.
28. Inability to comply with protocol.
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Principal Investigators
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Boehringer Ingelheim Study Coordinator
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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Boehringer Ingelheim Investigational Site
Huntsville, Alabama, United States
Research Solutions, LLC
Little Rock, Arkansas, United States
Boehringer Ingelheim Investigational Site
Carmichael, California, United States
Boehringer Ingelheim Investigational Site
Concord, California, United States
Sierra Medical Research
Fresno, California, United States
Attn: Ginger Paselk
Long Beach, California, United States
Boehringer Ingelheim Investigational Site
Orange, California, United States
DeBruin Medical Center
Orangevale, California, United States
Clinical Trials Research
Roseville, California, United States
Dr. R. David Ferrera
Sacramento, California, United States
Westlake Medical Research
Westlake Village, California, United States
Rocky Mountain Pulmonary & Critical Care Medicine, Inc.
Wheat Ridge, Colorado, United States
Clinical Research Consultants, Inc.
Trumbull, Connecticut, United States
Glasgow Family Pract6ice
Newark, Delaware, United States
Boehringer Ingelheim Investigational Site
Coral Gables, Florida, United States
Miami Research Associates
Coral Gables, Florida, United States
Patron, Andres, D.O.
Hollywood, Florida, United States
Christopher Chappel, MD
Kissimmee, Florida, United States
Boehringer Ingelheim Investigational Site
Melbourne, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Attention: Larry I. Gilderman, D.O.
Pembroke Pines, Florida, United States
nTouch Research
St. Petersburg, Florida, United States
Tampa Medical Research Associates
Tampa, Florida, United States
Southern Clinical Research and Management, Inc.
Augusta, Georgia, United States
Boehringer Ingelheim Investigational Site
Conyers, Georgia, United States
Treasure Valley Cardiology
Boise, Idaho, United States
Cedar-Crosse Research Center
Chicago, Illinois, United States
Herron Medical Center, Ltd.
Chicago, Illinois, United States
Protococare Trials, Inc.
Elk Grove Village, Illinois, United States
N Touch Research
Peoria, Illinois, United States
Midwest Institute for Clinical Research Inc.
Indianapolis, Indiana, United States
Radiant Research
Overland, Kansas, United States
Ong Medical Center
Oxon Hill, Maryland, United States
Radiant Research
Edina, Minnesota, United States
Cardiology Research
Saint Paul, Minnesota, United States
Attention: Mel E. Lucas, DO
Florissant, Missouri, United States
New Mexico Clinical Reaearch & Osteoporosis Center, Inc.
Albuquerque, New Mexico, United States
Syracuse Preventative Cardiology
Syracuse, New York, United States
Great Lakes Medical Research
Westfield, New York, United States
Cardiology and Internal Medicine- Williamsville NY
Williamsville, New York, United States
Comprehensive Clinical Research
Bina, North Carolina, United States
Bennett Cardiac Center
Charlotte, North Carolina, United States
Charlotte Clinical Research
Charlotte, North Carolina, United States
Boehringer Ingelheim Investigational Site
Raleigh, North Carolina, United States
nTouch Research Corporation
Raleigh, North Carolina, United States
Piedmont Research Associates
Winston-Salem, North Carolina, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
Radiant Reseach
Cincinnati, Ohio, United States
Radiant Research
Columbus, Ohio, United States
Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
nTouch
Oklahoma City, Oklahoma, United States
Hillcrest Medical Center
Tulsa, Oklahoma, United States
Bock Clinical Research
Collegeville, Pennsylvania, United States
Bock Clinical Research
Downingtown, Pennsylvania, United States
Bock Clinical Research
Harleysville, Pennsylvania, United States
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Omega Research
Warwick, Rhode Island, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Veterans Affairs Medical Center
Memphis, Tennessee, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, United States
Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
nTouch Research
Houston, Texas, United States
Hampton Roads Medical Specialists
Hampton, Virginia, United States
885 Kempsville Road, Suite 221
Norfolk, Virginia, United States
York Clinical Research
Norfolk, Virginia, United States
Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
Gemini Scientific
Madison, Wisconsin, United States
University of Wisconsin Medical School
Madison, Wisconsin, United States
Countries
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Other Identifiers
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502.387
Identifier Type: -
Identifier Source: org_study_id