Telmisartan vs. Valsartan in Patients With Mild to Moderate Hypertension Following a Missed Dose

Completed · Phase 4

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT00034840

Run by

Boehringer Ingelheim

People needed

490

Starts

2001-10-01

Expected to finish

2002-08-01

Last updated by the study team

2013-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 A.M.
• Mean sitting SBP =180 mm Hg or mean sitting DBP =110 mm Hg during any visit of the placebo run-in period.
• Known or suspected secondary hypertension (i.e., pheochromocytoma).
• 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.
• Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia.
• Uncorrected volume depletion.
• Primary aldosteronism.
• Hereditary fructose intolerance.
• Biliary obstructive disorders.
• Congestive heart failure (NYHA functional class CHF III-IV).
• Unstable angina within the past three months prior to signing the informed consent form.
• Stroke within the past six months prior to signing the informed consent form.
• Myocardial infarction or cardiac surgery within the past three months prior to signing the informed consent form.
• PTCA (percutaneous transluminal coronary revascularization) within the past three months prior to signing the informed consent form.
• Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
• Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve.
• 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%.
• Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists.

Where it is running

• Memorial Research Medical Clinic — Long Beach, California, United States
• National Research Institute — Los Angeles, California, United States
• Orange County Research Center — Orange, California, United States
• University of Conn. Health Services Center, Hypertension and Vascular Disease — Farmington, Connecticut, United States
• Alan Graff — Fort Lauderdale, Florida, United States
• Greater Ft. Lauderdale Heart Group Research — Fort Lauderdale, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States
• So. Clinical Research and Management, Inc. — Augusta, Georgia, United States
• Rush Presbyterian/St. Luke's Medical Center — Chicago, Illinois, United States
• University of Maryland/Nephrology Clinical Research Unit — Baltimore, Maryland, 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
• Harleysville Medical Associates — Harleysville, Pennsylvania, United States
• Trinity Hypertension Research Institute/Punzi Medical Center — Carrollton, Texas, United States
• UW Health/Physicians Plus Center for Clinical Trials — Madison, Wisconsin, United States
• Heart Health Institute — Calgary, Alberta, Canada
• Dr. Dennis O'Keefe — Mount Pearl, Newfoundland and Labrador, Canada
• Dr. William Booth — Antigonish Nova Scotia, Nova Scotia, Canada
• MSHJ Research Assoc. — Halifax, Nova Scotia, Canada
• Dr. Joseph Berlingieri — Burlington, Ontario, Canada
• Dr. William Mahoney — Corunna, Ontario, Canada
• BBM Clinical Research Ltd. — Courtice, Ontario, Canada
• Dr. Richard Tytus — Hamilton, Ontario, Canada
• Total Concept Health Care — Kitchener, Ontario, Canada

Full record on ClinicalTrials.gov

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