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

Condition(s) targeted: Hypertension

Intervention: telmisartan, valsartan (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: Boehringer Ingelheim

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.

Official title: A Prospective, Randomized, Double-Blind, Forced Titration Trial to Compare the Efficacy of MICARDIS® (Telmisartan 80 mg p.o. Once Daily) and Diovan® (Valsartan 160 mg p.o. Once Daily) Using Ambulatory Blood Pressure Monitoring (ABPM) in Patients With Mild to Moderate Hypertension After Missing One Dose

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

Change in the 24-hour mean diastolic blood pressure (DBP), as measured by ABPM after a missed dose

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

Secondary outcome:

Change in 24-hour ABPM mean systolic blood pressure (SBP) after a missed dose

Change in the last 6 hour ABPM mean SBP measured after a dose of active treatment

Changes in ABPM mean DBP and SBP during other periods of the 24-hour dosing interval after an active dose

Changes in ABPM mean DBP and SBP during other periods of the 24-hour dosing interval after a missed dose

Changes in in-clinic mean seated trough DBP and SBP as measured by manual cuff sphygmomanometer after a missed dose

Changes in in-clinic mean seated trough DBP and SBP as measured by manual cuff sphygmomanometer after an active dose

Responder rates based on ABPM

Responder rates based on in-clinic trough cuff blood pressures

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Heart Health Institute, Calgary, Alberta T2E 7C5, Canada

Memorial Research Medical Clinic, Long Beach, California 90806, United States

National Research Institute, Los Angeles, California 90057, United States

Orange County Research Center, Orange, California 92868, United States

University of Conn. Health Services Center, Hypertension and Vascular Disease, Farmington, Connecticut 06030, United States

Alan Graff, Fort Lauderdale, Florida 33308, United States

Greater Ft. Lauderdale Heart Group Research, Ft. Lauderdale, Florida 33308, United States

Orlando Clinical Research Center, Orlando, Florida 32806, United States

So. Clinical Research and Management, Inc., Augusta, Georgia 30904, United States

Rush Presbyterian/St. Luke's Medical Center, Chicago, Illinois 60612, United States

University of Maryland/Nephrology Clinical Research Unit, Baltimore, Maryland 21201, United States

Washington University, St. Louis, Missouri 63110, United States

Dr. Dennis O'Keefe, Mount Pearl, Newfoundland and Labrador A1N 2C3, Canada

Dr. William Booth, Antigonish, Nova Scotia B2G 2C2, Canada

MSHJ Research Assoc., Halifax, Nova Scotia B3K 5R3, Canada

Oklahoma Cardiovascular and Hypertension Center, Oklahoma City, Oklahoma 73132, United States

Dr. Joseph Berlingieri, Burlington, Ontario L7R 2H3, Canada

Dr. William Mahoney, Corunna, Ontario N0N 1G0, Canada

BBM Clinical Research Ltd., Courtice, Ontario L1E 3C3, Canada

Dr. Richard Tytus, Hamilton, Ontario L8M 1K7, Canada

Total Concept Health Care, Kitchener, Ontario N2C 2N9, Canada

Centre for Activity and Aging, London, Ontario N6G 2M3, Canada

Dr. Martyn Chilvers, Sarnia, Ontario N7T 4X3, Canada

Sunnybrook & Women's College Health Centre, Toronto, Ontario M4N 3M5, Canada

Michael A. Azorr, M.D., Portland, Oregon 97232, United States

Harleysville Medical Associates, Harleysville, Pennsylvania 19438, United States

Theradev Clinical Research, Inc., Granby, Quebec J2G 8Z9, Canada

Invascor, Longueuil, Longueuil, Quebec J4N 1E1, Canada

Hotel Dieu de St-Jerome, Saint Jerome, Quebec J7Z 5T3, Canada

Centre de Cardiologie, Saint Lambert, Quebec J4P 2H4, Canada

Centre Hospital Quebec - PAC CHUL Unite de Recherche, Sainte-Foy, Quebec G1V 4G2, Canada

Q&T Research, Sherbrooke, Quebec J1H 4J6, Canada

Royal University Hospital, Saskatoon, Saskatchewan S7N 0W8, Canada

Trinity Hypertension Research Institute/Punzi Medical Center, Carrollton, Texas 75006, United States

UW Health/Physicians Plus Center for Clinical Trials, Madison, Wisconsin 53715, United States

Starting date: October 2001
Last updated: October 31, 2013