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Telmisartan vs. Valsartan Missed Dose
This study has been completed.
First Received: May 2, 2002   Last Updated: September 24, 2009   History of Changes
Sponsor: Boehringer Ingelheim Pharmaceuticals
Collaborators: GlaxoSmithKline
Bayer
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00034840
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: telmisartan, valsartan
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title: A Prospective, Randomized, Double-blind, Forced Titration Trial to Compare the Efficacy of Micardis® (Telmisartan) (80 mg p.o. Once Daily) and Valsartan (160 mg p.o. Once Daily) in Patients With Mild-to-moderate Hypertension After Missing One Dose Using Ambulatory Blood Pressure Monitoring.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Estimated Enrollment: 840
Study Start Date: October 2001
Estimated Study Completion Date: August 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00034840

  Hide Study Locations
Locations
United States, California
Memorial Research Medical Clinic
Long Beach, California, United States, 90806
National Research Institute
Los Angeles, California, United States, 90057
Orange County Research Center
Orange, California, United States, 92868
United States, Connecticut
University of Conn. Health Services Center, Hypertension and Vascular Disease
Farmington, Connecticut, United States, 06030
United States, Florida
Alan Graff
Fort Lauderdale, Florida, United States, 33308
Orlando Clinical Research Center
Orlando, Florida, United States, 32806
Greater Ft. Lauderdale Heart Group Research
Ft. Lauderdale, Florida, United States, 33308
United States, Georgia
So. Clinical Research and Management, Inc.
Augusta, Georgia, United States, 30904
United States, Illinois
Rush Presbyterian/St. Luke's Medical Center
Chicago, Illinois, United States, 60612
United States, Maryland
University of Maryland/Nephrology Clinical Research Unit
Baltimore, Maryland, United States, 21201
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, Oklahoma
Oklahoma Cardiovascular and Hypertension Center
Oklahoma City, Oklahoma, United States, 73132
United States, Oregon
Michael A. Azorr, M.D.
Portland, Oregon, United States, 97232
United States, Pennsylvania
Harleysville Medical Associates
Harleysville, Pennsylvania, United States, 19438
United States, Texas
Trinity Hypertension Research Institute/Punzi Medical Center
Carrollton, Texas, United States, 75006
United States, Wisconsin
UW Health/Physicians Plus Center for Clinical Trials
Madison, Wisconsin, United States, 53715
Canada, Alberta
Heart Health Institute
Calgary, Alberta, Canada, T2E 7C5
Canada, Newfoundland and Labrador
Dr. Dennis O'Keefe
Mount Pearl, Newfoundland and Labrador, Canada, A1N 2C3
Canada, Nova Scotia
Dr. William Booth
Antigonish, Nova Scotia, Canada, B2G 2C2
MSHJ Research Assoc.
Halifax, Nova Scotia, Canada, B3K 5R3
Canada, Ontario
Dr. Joseph Berlingieri
Burlington, Ontario, Canada, L7R 2H3
BBM Clinical Research Ltd.
Courtice, Ontario, Canada, L1E 3C3
Centre for Activity and Aging
London, Ontario, Canada, N6G 2M3
Sunnybrook & Women's College Health Centre
Toronto, Ontario, Canada, M4N 3M5
Dr. Richard Tytus
Hamilton, Ontario, Canada, L8M 1K7
Dr. William Mahoney
Corunna, Ontario, Canada, N0N 1G0
Total Concept Health Care
Kitchener, Ontario, Canada, N2C 2N9
Dr. Martyn Chilvers
Sarnia, Ontario, Canada, N7T 4X3
Canada, Quebec
Theradev Clinical Research, Inc.
Granby, Quebec, Canada, J2G 8Z9
Centre de Cardiologie
Saint Lambert, Quebec, Canada, J4P 2H4
Centre Hospital Quebec - PAC CHUL Unite de Recherche
Sainte-Foy, Quebec, Canada, G1V 4G2
Invascor, Longueuil
Longueuil, Quebec, Canada, J4N 1E1
Q&T Research
Sherbrooke, Quebec, Canada, J1H 4J6
Hotel Dieu de St-Jerome
Saint Jerome, Quebec, Canada, J7Z 5T3
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
GlaxoSmithKline
Bayer
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Pharmaceuticals
  More Information

Additional Information:
No publications provided

Study ID Numbers: 502.327
Study First Received: May 2, 2002
Last Updated: September 24, 2009
ClinicalTrials.gov Identifier: NCT00034840     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Boehringer Ingelheim Pharmaceuticals:
hypertension
telmisartan
valsartan
boehringer

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors
Angiotensin II Type 1 Receptor Blockers
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Telmisartan
Valsartan
Hypertension

ClinicalTrials.gov processed this record on November 27, 2009