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Home > "T" Clinical Trials Conditions > Telmisartan vs. valsartan missed dose  Telmisartan vs. valsartan missed dose
Telmisartan vs. valsartan missed dose
For Condition: Hypertension
Status: Completed
Sponsor(s): Boehringer Ingelheim Pharmaceuticals ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: 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. Exclusion Criteria: 1. 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. 2. Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 A.M. 3. Mean sitting SBP =180 mm Hg or mean sitting DBP =110 mm Hg during any visit of the placebo run-in period. 4. Known or suspected secondary hypertension (i.e., pheochromocytoma). 5. 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). 6. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney. 7. Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia. 8. Uncorrected volume depletion. 9. Primary aldosteronism. 10. Hereditary fructose intolerance. 11. Biliary obstructive disorders. 12. Congestive heart failure (NYHA functional class CHF III-IV). 13. Unstable angina within the past three months prior to signing the informed consent form. 14. Stroke within the past six months prior to signing the informed consent form. 15. Myocardial infarction or cardiac surgery within the past three months prior to signing the informed consent form. 16. PTCA (percutaneous transluminal coronary revascularization) within the past three 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 three months as defined by an HbA1C =10%. 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 one month of signing the informed consent form. 24. Known hypersensitivity to any component of the formulations. 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. Inability to comply with the protocol.
Total Enrollment: 840
Location and Contact Information:
Dr. Richard Tytus
Hamilton, Ontario, L8M 1K7
Canada
Dr. Dennis O'Keefe
Mount Pearl, Newfoundland and Labrador, A1N 2C3
Canada
Trinity Hypertension Research Institute/Punzi Medical Center
Carrollton, Texas, 75006
United States
Total Concept Health Care
Kitchener, Ontario, N2C 2N9
Canada
Dr. William Mahoney
Corunna, Ontario, N0N 1G0
Canada
Heart Health Institute
Calgary, Alberta, T2E 7C5
Canada
BBM Clinical Research Ltd.
Courtice, Ontario, L1E 3C3
Canada
Orlando Clinical Research Center
Orlando, Florida, 32806
United States
Centre Hospital Quebec - PAC CHUL Unite de Recherche
Sainte-Foy, Quebec, G1V 4G2
Canada
So. Clinical Research and Management, Inc.
Augusta, Georgia, 30904
United States
Michael A. Azorr, M.D.
Portland, Oregon, 97232
United States
Dr. Joseph Berlingieri
Burlington, Ontario, L7R 2H3
Canada
Sunnybrook & Women's College Health Centre
Toronto, Ontario, M4N 3M5
Canada
MSHJ Research Assoc.
Halifax, Nova Scotia, B3K 5R3
Canada
University of Conn. Health Services Center, Hypertension and Vascular Disease
Farmington, Connecticut, 06030
United States
Q&T Research
Sherbrooke, Quebec, J1H 4J6
Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
Canada
Centre de Cardiologie
Saint-Lambert, Quebec, J4P 2H4
Canada
Alan Graff
Ft. Lauderdale, Florida, 33308
United States
Washington University
St. Louis, Missouri, 63110
United States
Dr. Martyn Chilvers
Sarnia, Ontario, N7T 4X3
Canada
Memorial Research Medical Clinic
Long Beach, California, 90806
United States
UW Health/Physicians Plus Center for Clinical Trials
Madison, Wisconsin, 53715
United States
Centre for Activity and Aging
London, Ontario, N6G 2M3
Canada
Rush Presbyterian/St. Luke's Medical Center
Chicago, Illinois, 60612
United States
Dr. William Booth
Antigonish, Nova Scotia, B2G 2C2
Canada
Oklahoma Cardiovascular and Hypertension Center
Oklahoma City, Oklahoma, 73132
United States
National Research Institute
Los Angeles, California, 90057
United States
Hotel Dieu de St-Jerome
Saint-Jerome, Quebec, J7Z 5T3
Canada
Greater Ft. Lauderdale Heart Group Research
Ft. Lauderdale, Florida, 33308
United States
University of Maryland/Nephrology Clinical Research Unit
Baltimore, Maryland, 21201
United States
Theradev Clinical Research, Inc.
Granby, Quebec, J2G 8Z9
Canada
Invascor, Longueuil
Longueuil, Quebec, J4N 1E1
Canada
Harleysville Medical Associates
Harleysville, Pennsylvania, 19438
United States
Orange County Research Center
Orange, California, 92868
United States
Additional Information:
Study ID Numbers: BI 502.327;
Study Start Date:
Record last reviewed: November 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034840
Other Hypertension Studies:
1. Treatment of Hypertension
2. Metabolic Differences of Overweight Children and Children of Overweight Parents
3. Treatment of Hypertension with Two Exercise Intensities
4. Evaluating "Health at Every Size"(HAES) as an Alternative Obesity Treatment Model
5. Segregation/Linkage Analysis for Hypertension
Related Studies:
Other Hypertension Clinical Trials
Other California Clinical Trials
Other Long Beach Clinical Trials
Telmisartan vs. valsartan missed dose
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