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)
- Conditions
- Hypertension
- Registration Number
- NCT00274638
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To demonstrate that Telmisartan combined with Hydrochlorothiazide (MICARDIS® HCT) is superior to Losartan with Hydrochlorothiazide (Hyzaar®) in lowering blood pressure in mild-moderate hypertensives.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 805
- Ability to provide written informed consent in accordance with GCP and local legislation.
- 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.
- Male or Female >= 18 years.
- Ability to stop any current antihypertensive therapy without risk to the patient (investigator's discretion).
- 24-hour ABPM mean DBP of >= 85 mm Hg at Visit 3.
-
Pre-menopausal women (last menstruation <= 1 year prior to signing informed consent) who
- 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.
-
Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 A.M.
-
Mean seated SBP >= 180 mm Hg or mean seated DBP >= 110 mm Hg during any visit or the placebo run-in phase.
-
Known or suspected secondary hypertension (i.e. pheochromocytoma).
-
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).
-
Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
-
Biliary obstructive disorders.
-
Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia.
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Uncorrected volume depletion.
-
Primary aldosteronism.
-
Hereditary fructose intolerance.
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Congestive heart failure (NYHA functional class CHF III-IV).
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Unstable angina within the past 3 months prior to signing the informed consent form.
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Stroke within the past 6 months prior to signing the informed consent form.
-
Myocardial infarction or cardiac surgery within the past 3 months prior to signing the inform consent form.
-
PTCA (percutaneous transluminal coronary angioplasty) within the past 3 months prior to signing the informed consent form.
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Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
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Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve.
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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.
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Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists.
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History of drug or alcohol dependency within 6 months prior to signing the informed consent form.
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Chronic administration of any medications known to affect blood pressure, except medication allowed by the protocol.
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Any investigational therapy within 1 month of signing the informed consent form.
-
Known hypersensitivity to any component of the study drugs (placebo, telmisartan, hydrochlorothiazide or losartan).
-
Any clinical condition which, in the opinion of the investigator would not allow safe completion of the protocol and safe administration of trial medication.
-
Concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with hydrochlorothiazide).
-
History of non-compliance with prescribed medication.
-
Inability to comply with protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline in the last 6-hour mean (relative to dose time) diastolic blood pressure (DBP) as measured by ABPM (Ambulatory Blood Pressure Monitoring) after 6 Weeks
- Secondary Outcome Measures
Name Time Method Responder rates based on both the 24-hour ABPM mean (relative to dose time) blood pressures and the in-clinic trough cuff measurements after 6 weeks Change in the last 6-hour ABPM mean (relative to dosing time) for systolic blood pressure (SBP) after 6 weeks Change in systolic and diastolic blood pressure load during the 24-hour dosing interval of the 24-hour dosing interval after 6 weeks Change in the ABPM mean DBP and SBP during the morning, daytime, and night-time periods of the 24-hour dosing interval after 6 weeks Change in mean seated trough DBP and SBP as measured by manual in-clinic cuff sphygmomanometer after 6 weeks Change in the 24-hour ABPM mean (relative to dosing time) for DBP and SBP after 6 weeks
Trial Locations
- Locations (53)
Herron Medical Center, Ltd.
🇺🇸Chicago, Illinois, United States
Midwest Institute for Clinical Research Inc.
🇺🇸Indianapolis, Indiana, United States
nTouch Research
🇺🇸Houston, Texas, United States
Clinical Research Associates, Inc.
🇺🇸Nashville, Tennessee, United States
Tampa Medical Research Associates
🇺🇸Tampa, Florida, United States
Boehringer Ingelheim Investigational Site
🇺🇸Richmond, Virginia, United States
DeBruin Medical Center
🇺🇸Orangevale, California, United States
Clinical Trials Research
🇺🇸Roseville, California, United States
Glasgow Family Pract6ice
🇺🇸Newark, Delaware, United States
Rocky Mountain Pulmonary & Critical Care Medicine, Inc.
🇺🇸Wheat Ridge, Colorado, United States
Westlake Medical Research
🇺🇸Westlake Village, California, United States
Clinical Research Consultants, Inc.
🇺🇸Trumbull, Connecticut, United States
Attention: Larry I. Gilderman, D.O.
🇺🇸Pembroke Pines, Florida, United States
Treasure Valley Cardiology
🇺🇸Boise, Idaho, United States
Cedar-Crosse Research Center
🇺🇸Chicago, Illinois, United States
N Touch Research
🇺🇸Peoria, Illinois, United States
Protococare Trials, Inc.
🇺🇸Elk Grove Village, Illinois, United States
Ong Medical Center
🇺🇸Oxon Hill, Maryland, United States
Cardiology Research
🇺🇸St. Paul, Minnesota, United States
nTouch Research Corporation
🇺🇸Raleigh, North Carolina, United States
Radiant Reseach
🇺🇸Cincinnati, Ohio, United States
Syracuse Preventative Cardiology
🇺🇸Syracuse, New York, United States
Attention: Mel E. Lucas, DO
🇺🇸Florissant, Missouri, United States
Piedmont Research Associates
🇺🇸Winston Salem, North Carolina, United States
York Clinical Research
🇺🇸Norfolk, Virginia, United States
Bock Clinical Research
🇺🇸Harleysville, Pennsylvania, United States
nTouch
🇺🇸Oklahoma City, Oklahoma, United States
Charlotte Clinical Research
🇺🇸Charlotte, North Carolina, 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
🇺🇸Berlin, North Carolina, United States
Hillcrest Medical Center
🇺🇸Tulsa, Oklahoma, United States
Veterans Affairs Medical Center
🇺🇸Memphis, Tennessee, United States
885 Kempsville Road, Suite 221
🇺🇸Norfolk, Virginia, United States
Gemini Scientific
🇺🇸Madison, Wisconsin, United States
Hampton Roads Medical Specialists
🇺🇸Hampton, Virginia, United States
Omega Research
🇺🇸Warwick, Rhode Island, United States
Research Solutions, LLC
🇺🇸Little Rock, Arkansas, United States
Southern Clinical Research and Management, Inc.
🇺🇸Augusta, Georgia, United States
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
Sierra Medical Research
🇺🇸Fresno, California, United States
Attn: Ginger Paselk
🇺🇸Long Beach, California, United States
Patron, Andres, D.O.
🇺🇸Hollywood, Florida, United States
Christopher Chappel, MD
🇺🇸Kissimmee, Florida, United States
Miami Research Associates
🇺🇸Coral Gables, Florida, United States
New Mexico Clinical Reaearch & Osteoporosis Center, Inc.
🇺🇸Alburquerque, New Mexico, United States
Bennett Cardiac Center
🇺🇸Charlotte, North Carolina, United States
The Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Wake Forest University School of Medicine
🇺🇸Winston Salem, North Carolina, United States
Dr. R. David Ferrera
🇺🇸Sacramento, California, United States
Orlando Clinical Research Center
🇺🇸Orlando, Florida, United States
University of Wisconsin Medical School
🇺🇸Madison, Wisconsin, United States
Radiant Research
🇺🇸Columbus, Ohio, United States