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PROBE Parallel 6-week Treatment Comparing Telmisartan/Hydrochlorothiazide (HCT) (40/12.5 or 80/12.5) With Losartan/HCT (50/12.5) Using Ambulatory Blood Pressure Monitoring (ABPM)

6. december 2013 opdateret af: Boehringer Ingelheim

A Prospective, Randomised, Open-Label, Blinded-Endpoint, Parallel Group 6-week Treatment Study Comparing Telmisartan Combined With Hydrochlorothiazide (40 mg/12.5 mg or 80 mg/12.5 mg) Tablets With Losartan Combined With Hydrochlorothiazide (50 mg/12.5 mg) Tablets Using Ambulatory Blood Pressure Monitoring in Patients With Mild-to-Moderate Hypertension

To demonstrate that Telmisartan combined with Hydrochlorothiazide (MICARDIS® HCT) is superior to Losartan with Hydrochlorothiazide (Hyzaar®) in lowering blood pressure in mild-moderate hypertensives.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

805

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Huntsville, Alabama, Forenede Stater
        • Boehringer Ingelheim Investigational Site
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater
        • Research Solutions, LLC
    • California
      • Carmichael, California, Forenede Stater
        • Boehringer Ingelheim Investigational Site
      • Concord, California, Forenede Stater
        • Boehringer Ingelheim Investigational Site
      • Fresno, California, Forenede Stater
        • Sierra Medical Research
      • Long Beach, California, Forenede Stater
        • Attn: Ginger Paselk
      • Orange, California, Forenede Stater
        • Boehringer Ingelheim Investigational Site
      • Orangevale, California, Forenede Stater
        • DeBruin Medical Center
      • Roseville, California, Forenede Stater
        • Clinical Trials Research
      • Sacramento, California, Forenede Stater
        • Dr. R. David Ferrera
      • Westlake Village, California, Forenede Stater
        • Westlake Medical Research
    • Colorado
      • Wheat Ridge, Colorado, Forenede Stater
        • Rocky Mountain Pulmonary & Critical Care Medicine, Inc.
    • Connecticut
      • Trumbull, Connecticut, Forenede Stater
        • Clinical Research Consultants, Inc.
    • Delaware
      • Newark, Delaware, Forenede Stater
        • Glasgow Family Pract6ice
    • Florida
      • Coral Gables, Florida, Forenede Stater
        • Boehringer Ingelheim Investigational Site
      • Coral Gables, Florida, Forenede Stater
        • Miami Research Associates
      • Hollywood, Florida, Forenede Stater
        • Patron, Andres, D.O.
      • Kissimmee, Florida, Forenede Stater
        • Christopher Chappel, MD
      • Melbourne, Florida, Forenede Stater
        • Boehringer Ingelheim Investigational Site
      • Orlando, Florida, Forenede Stater
        • Orlando Clinical Research Center
      • Pembroke Pines, Florida, Forenede Stater
        • Attention: Larry I. Gilderman, D.O.
      • St. Petersburg, Florida, Forenede Stater
        • nTouch Research
      • Tampa, Florida, Forenede Stater
        • Tampa Medical Research Associates
    • Georgia
      • Augusta, Georgia, Forenede Stater
        • Southern Clinical Research and Management, Inc.
      • Conyers, Georgia, Forenede Stater
        • Boehringer Ingelheim Investigational Site
    • Idaho
      • Boise, Idaho, Forenede Stater
        • Treasure Valley Cardiology
    • Illinois
      • Chicago, Illinois, Forenede Stater
        • Cedar-Crosse Research Center
      • Chicago, Illinois, Forenede Stater
        • Herron Medical Center, Ltd.
      • Elk Grove Village, Illinois, Forenede Stater
        • Protococare Trials, Inc.
      • Peoria, Illinois, Forenede Stater
        • N Touch Research
    • Indiana
      • Indianapolis, Indiana, Forenede Stater
        • Midwest Institute for Clinical Research Inc.
    • Kansas
      • Overland, Kansas, Forenede Stater
        • Radiant Research
    • Maryland
      • Oxon Hill, Maryland, Forenede Stater
        • Ong Medical Center
    • Minnesota
      • Edina, Minnesota, Forenede Stater
        • Radiant Research
      • St. Paul, Minnesota, Forenede Stater
        • Cardiology Research
    • Missouri
      • Florissant, Missouri, Forenede Stater
        • Attention: Mel E. Lucas, DO
    • New Mexico
      • Alburquerque, New Mexico, Forenede Stater
        • New Mexico Clinical Reaearch & Osteoporosis Center, Inc.
    • New York
      • Syracuse, New York, Forenede Stater
        • Syracuse Preventative Cardiology
      • Westfield, New York, Forenede Stater
        • Great Lakes Medical Research
      • Williamsville, New York, Forenede Stater
        • Cardiology and Internal Medicine- Williamsville NY
    • North Carolina
      • Berlin, North Carolina, Forenede Stater
        • Comprehensive Clinical Research
      • Charlotte, North Carolina, Forenede Stater
        • Bennett Cardiac Center
      • Charlotte, North Carolina, Forenede Stater
        • Charlotte Clinical Research
      • Raleigh, North Carolina, Forenede Stater
        • Boehringer Ingelheim Investigational Site
      • Raleigh, North Carolina, Forenede Stater
        • nTouch Research Corporation
      • Winston Salem, North Carolina, Forenede Stater
        • Piedmont Research Associates
      • Winston Salem, North Carolina, Forenede Stater
        • Wake Forest University School of Medicine
    • Ohio
      • Cincinnati, Ohio, Forenede Stater
        • Boehringer Ingelheim Investigational Site
      • Cincinnati, Ohio, Forenede Stater
        • Radiant Reseach
      • Columbus, Ohio, Forenede Stater
        • Radiant Research
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater
        • Boehringer Ingelheim Investigational Site
      • Oklahoma City, Oklahoma, Forenede Stater
        • nTouch
      • Tulsa, Oklahoma, Forenede Stater
        • Hillcrest Medical Center
    • Pennsylvania
      • Collegeville, Pennsylvania, Forenede Stater
        • Bock Clinical Research
      • Downingtown, Pennsylvania, Forenede Stater
        • Bock Clinical Research
      • Harleysville, Pennsylvania, Forenede Stater
        • Bock Clinical Research
      • Pittsburgh, Pennsylvania, Forenede Stater
        • The Western Pennsylvania Hospital
    • Rhode Island
      • Warwick, Rhode Island, Forenede Stater
        • Omega Research
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater
        • University of Tennessee Medical Center
      • Memphis, Tennessee, Forenede Stater
        • Veterans Affairs Medical Center
      • Nashville, Tennessee, Forenede Stater
        • Clinical Research Associates, Inc.
    • Texas
      • Dallas, Texas, Forenede Stater
        • Boehringer Ingelheim Investigational Site
      • Houston, Texas, Forenede Stater
        • nTouch Research
    • Virginia
      • Hampton, Virginia, Forenede Stater
        • Hampton Roads Medical Specialists
      • Norfolk, Virginia, Forenede Stater
        • 885 Kempsville Road, Suite 221
      • Norfolk, Virginia, Forenede Stater
        • York Clinical Research
      • Richmond, Virginia, Forenede Stater
        • Boehringer Ingelheim Investigational Site
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater
        • Gemini Scientific
      • Madison, Wisconsin, Forenede Stater
        • University of Wisconsin Medical School

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Ability to provide written informed consent in accordance with GCP and local legislation.
  2. Mild-to-moderate hypertension defined as a mean seated DBP of >= 95 mm Hg and <=l to 109 mm Hg, measured by manual cuff sphygmomanometer at Visit 2.
  3. Male or Female >= 18 years.
  4. Ability to stop any current antihypertensive therapy without risk to the patient (investigator's discretion).
  5. 24-hour ABPM mean DBP of >= 85 mm Hg at Visit 3.

Exclusion Criteria:

  1. Pre-menopausal women (last menstruation <= 1 year prior to signing informed consent) who

    • are not surgically sterile, or are
    • nursing, or
    • 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 exception 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 seated SBP >= 180 mm Hg or mean seated DBP >= 110 mm Hg during any visit or the placebo run-in phase.
  4. Known or suspected secondary hypertension (i.e. pheochromocytoma).
  5. Hepatic and/or renal dysfunction as defined by the following laboratory parameters: a)SGPT (ALT) or (SGOT) AST less than two times the upper limit of normal range, or b)Serum creatinine greater than 2.3 mg/dL (>203 mico mol/l).
  6. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
  7. Biliary obstructive disorders.
  8. Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia.
  9. Uncorrected volume depletion.
  10. Primary aldosteronism.
  11. Hereditary fructose intolerance.
  12. Congestive heart failure (NYHA functional class CHF III-IV).
  13. Unstable angina within the past 3 months prior to signing the informed consent form.
  14. Stroke within the past 6 months prior to signing the informed consent form.
  15. Myocardial infarction or cardiac surgery within the past 3 months prior to signing the inform consent form.
  16. PTCA (percutaneous transluminal coronary angioplasty) within the past 3 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 3 months as defined by an HbA1C >= 10 Percent.
  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 1 month of signing the informed consent form.
  24. Known hypersensitivity to any component of the study drugs (placebo, telmisartan, hydrochlorothiazide or losartan).
  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. Concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with hydrochlorothiazide).
  27. History of non-compliance with prescribed medication.
  28. Inability to comply with protocol.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change from baseline in the last 6-hour mean (relative to dose time) diastolic blood pressure (DBP) as measured by ABPM (Ambulatory Blood Pressure Monitoring)
Tidsramme: after 6 Weeks
after 6 Weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Change in the last 6-hour ABPM mean (relative to dosing time) for systolic blood pressure (SBP)
Tidsramme: after 6 weeks
after 6 weeks
Change in the 24-hour ABPM mean (relative to dosing time) for DBP and SBP
Tidsramme: after 6 weeks
after 6 weeks
Change in the ABPM mean DBP and SBP during the morning, daytime, and night-time periods of the 24-hour dosing interval
Tidsramme: after 6 weeks
after 6 weeks
Change in systolic and diastolic blood pressure load during the 24-hour dosing interval of the 24-hour dosing interval
Tidsramme: after 6 weeks
after 6 weeks
Change in mean seated trough DBP and SBP as measured by manual in-clinic cuff sphygmomanometer
Tidsramme: after 6 weeks
after 6 weeks
Responder rates based on both the 24-hour ABPM mean (relative to dose time) blood pressures and the in-clinic trough cuff measurements
Tidsramme: after 6 weeks
after 6 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boehringer Ingelheim

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2002

Primær færdiggørelse (Faktiske)

1. juli 2003

Datoer for studieregistrering

Først indsendt

10. januar 2006

Først indsendt, der opfyldte QC-kriterier

10. januar 2006

Først opslået (Skøn)

11. januar 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. december 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. december 2013

Sidst verificeret

1. december 2013

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 502.387

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner