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Telmisartan vs. Valsartan Missed Dose
This study has been completed.

First Received on May 2, 2002.   Last Updated on 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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

  Show 35 Study Locations
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

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

Keywords provided by Boehringer Ingelheim Pharmaceuticals:
hypertension
telmisartan
valsartan
boehringer

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

ClinicalTrials.gov processed this record on February 09, 2012