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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: telmisartan, valsartan

• Study Type: Interventional
• Enrollment: 490
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim
• Collaborators: Bayer; GlaxoSmithKline

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 2001
• Primary Completion (Actual): August 1, 2002
• Study Completion: August 1, 2002

Study Registration Dates

• First Submitted: May 2, 2002
• First Submitted That Met QC Criteria: May 2, 2002
• First Posted (Estimate): May 3, 2002

Study Record Updates

• Last Update Posted (Estimate): November 1, 2013
• Last Update Submitted That Met QC Criteria: October 31, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: hypertension; valsartan; telmisartan; boehringer
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Valsartan; Telmisartan
• Other Study ID Numbers: 502.327