Telmisartan vs. Valsartan in Patients With Mild to Moderate Hypertension Following a Missed Dose
- Conditions
- Hypertension
- Registration Number
- NCT00034840
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 490
- 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.
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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.
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Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 A.M.
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Mean sitting SBP =180 mm Hg or mean sitting DBP =110 mm Hg during any visit of the placebo run-in period.
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Known or suspected secondary hypertension (i.e., pheochromocytoma).
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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).
-
Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
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Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia.
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Uncorrected volume depletion.
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Primary aldosteronism.
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Hereditary fructose intolerance.
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Biliary obstructive disorders.
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Congestive heart failure (NYHA functional class CHF III-IV).
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Unstable angina within the past three months prior to signing the informed consent form.
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Stroke within the past six months prior to signing the informed consent form.
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Myocardial infarction or cardiac surgery within the past three months prior to signing the informed consent form.
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PTCA (percutaneous transluminal coronary revascularization) within the past three 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 three months as defined by an HbA1C =10%.
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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 one month of signing the informed consent form.
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Known hypersensitivity to any component of the formulations.
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Any clinical condition which, in the opinion of the investigator would not allow safe completion of the protocol and safe administration of trial medication.
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Inability to comply with the protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in the 24-hour mean diastolic blood pressure (DBP), as measured by ABPM after a missed dose after 6 to 8 weeks Change in the mean DBP during the last 6 hours of the 24-hour dosing interval, as measured by ABPM after an active dose of study medication after 6 to 8 weeks
- Secondary Outcome Measures
Name Time Method Changes in in-clinic mean seated trough DBP and SBP as measured by manual cuff sphygmomanometer after an active dose 8 weeks Responder rates based on ABPM after 6 to 8 weeks Responder rates based on in-clinic trough cuff blood pressures after 6 to 8 weeks Change in the last 6 hour ABPM mean SBP measured after a dose of active treatment after 6 to 8 weeks Changes in ABPM mean DBP and SBP during other periods of the 24-hour dosing interval after an active dose 8 weeks Changes in ABPM mean DBP and SBP during other periods of the 24-hour dosing interval after a missed dose 8 weeks Changes in in-clinic mean seated trough DBP and SBP as measured by manual cuff sphygmomanometer after a missed dose 8 weeks Change in 24-hour ABPM mean systolic blood pressure (SBP) after a missed dose after 6 to 8 weeks
Trial Locations
- Locations (35)
National Research Institute
🇺🇸Los Angeles, California, United States
University of Conn. Health Services Center, Hypertension and Vascular Disease
🇺🇸Farmington, Connecticut, United States
University of Maryland/Nephrology Clinical Research Unit
🇺🇸Baltimore, Maryland, United States
Dr. Dennis O'Keefe
🇨🇦Mount Pearl, Newfoundland and Labrador, Canada
Royal University Hospital
🇨🇦Saskatoon, Saskatchewan, Canada
Memorial Research Medical Clinic
🇺🇸Long Beach, California, United States
Alan Graff
🇺🇸Fort Lauderdale, Florida, United States
Greater Ft. Lauderdale Heart Group Research
🇺🇸Ft. Lauderdale, Florida, United States
Orlando Clinical Research Center
🇺🇸Orlando, Florida, United States
Centre de Cardiologie
🇨🇦Saint Lambert, Quebec, Canada
Q&T Research
🇨🇦Sherbrooke, Quebec, Canada
Rush Presbyterian/St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
So. Clinical Research and Management, Inc.
🇺🇸Augusta, Georgia, United States
Washington University
🇺🇸St. Louis, Missouri, United States
Oklahoma Cardiovascular and Hypertension Center
🇺🇸Oklahoma City, Oklahoma, United States
Michael A. Azorr, M.D.
🇺🇸Portland, Oregon, United States
Trinity Hypertension Research Institute/Punzi Medical Center
🇺🇸Carrollton, Texas, United States
Dr. William Booth
🇨🇦Antigonish, Nova Scotia, Canada
MSHJ Research Assoc.
🇨🇦Halifax, Nova Scotia, Canada
Dr. Joseph Berlingieri
🇨🇦Burlington, Ontario, Canada
BBM Clinical Research Ltd.
🇨🇦Courtice, Ontario, Canada
Dr. William Mahoney
🇨🇦Corunna, Ontario, Canada
Total Concept Health Care
🇨🇦Kitchener, Ontario, Canada
Dr. Martyn Chilvers
🇨🇦Sarnia, Ontario, Canada
Dr. Richard Tytus
🇨🇦Hamilton, Ontario, Canada
Sunnybrook & Women's College Health Centre
🇨🇦Toronto, Ontario, Canada
Theradev Clinical Research, Inc.
🇨🇦Granby, Quebec, Canada
Invascor, Longueuil
🇨🇦Longueuil, Quebec, Canada
Hotel Dieu de St-Jerome
🇨🇦Saint Jerome, Quebec, Canada
Centre Hospital Quebec - PAC CHUL Unite de Recherche
🇨🇦Sainte-Foy, Quebec, Canada
Centre for Activity and Aging
🇨🇦London, Ontario, Canada
Heart Health Institute
🇨🇦Calgary, Alberta, Canada
Harleysville Medical Associates
🇺🇸Harleysville, Pennsylvania, United States
UW Health/Physicians Plus Center for Clinical Trials
🇺🇸Madison, Wisconsin, United States
Orange County Research Center
🇺🇸Orange, California, United States