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DORADO-AC-EX - A Long-Term Safety Extension Study to the Phase 3 DORADOC-AC Study (Protocol DAR-312) of Darusentan in Resistant Hypertension (Darusentan)

3. januar 2014 opdateret af: Gilead Sciences

A Double-Blind, Active-Controlled, Long-Term Safety Extension Study of Optimized Doses of Darusentan in Subjects With Resistant Hypertension Despite Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine (Protocol DAR-312-E)

This is a double-blind, active-controlled, long-term study of a new experimental drug called darusentan. Darusentan in not currently approved by the United States Food and Drug Administration (FDA), which means that a doctor cannot prescribe this drug. The purpose of this study is to evaluate the long-term safety of darusentan (optimized dose) as compared to an active control, administered orally.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

661

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Argentina
      • Bahia Blanca, Argentina
        • Instituto de Investigaciones Clínicas Bahia Blanca
      • Buenos Aires, Argentina
        • Consultorios Medicos Privados S.A.
      • Buenos Aires, Argentina
        • Policlinica Bancaria "9 de Julio"
      • Ciudad de Buenos Aires, Argentina
        • Diabaid (Instituto de Asistencia Integral en Diabetes)
      • Ciudad de Buenos Aires, Argentina
        • MD Investigaciones
      • Corrientes, Argentina
        • Instituto de Cardiologia de Corrientes
      • La Plata, Argentina
        • Framingham Centro Médico
      • Mar del Plata, Argentina
        • Instituto de Investigaciones Clínicas Mar del Plata
      • Quilmes, Argentina
        • Instituto de Investigaciones Clinicas de Quilmes
      • Rosario, Argentina
        • Instituto de Investigaciones Clínicas
      • Santa Fe, Argentina
        • Centro de Investigaciones clincas de Litoral
  • Australien
      • Bedford, Australien
        • Flinders Medical Centre
      • Perth, Australien
        • Royal Perth Hospital
  • Brasilien
      • Rio de Janeiro, Brasilien
        • Private Practice of Dr. Herwig Van Aerde
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35235
        • Alabama Internal Medicine, PC
      • Birmingham, Alabama, Forenede Stater, 35242
        • Greystone Medical Research, LLC
      • Huntsville, Alabama, Forenede Stater, 35801
        • The Heart Center, PC
      • Montgomery, Alabama, Forenede Stater, 36106
        • Mulberry Medical Associates, PC
    • Arizona
      • Glendale, Arizona, Forenede Stater, 85306
        • Arizona Center For Clinical Research
      • Glendale, Arizona, Forenede Stater, 85306
        • Cardiovascular Consultants, Ltd.
      • Phoenix, Arizona, Forenede Stater, 85016
        • Lovelace Scientific Resource, Inc.
      • Sierra Vista, Arizona, Forenede Stater, 85635
        • Cochise Clinical Research
      • Tucson, Arizona, Forenede Stater, 85715
        • Southwest Heart
    • Arkansas
      • Hot Springs, Arkansas, Forenede Stater, 71913
        • HealthFirst Physicians of AR, PA dba Convenient Care Clinic
      • Jonesboro, Arkansas, Forenede Stater, 72401
        • NEA Clinical
      • Little Rock, Arkansas, Forenede Stater, 72204
        • Arkansas Primary Care Clinic, PA
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Medical Investigators, Inc.
    • California
      • Bakersfield, California, Forenede Stater, 93301
        • Highgrove Medical Center
      • Bakersfield, California, Forenede Stater, 93308
        • Central Cardiology Medical Clinic
      • Beverly Hills, California, Forenede Stater, 90211
        • Impact Clinical Trials
      • Los Angeles, California, Forenede Stater, 90073
        • VA Greater Los Angeles Healthcare System
      • Rancho Cucamonga, California, Forenede Stater, 91730
        • Rancho Cucamonga Clinical Trials
      • Santa Monica, California, Forenede Stater, 90404
        • Pacific Heart Institute
      • Torrance, California, Forenede Stater, 90502
        • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80012
        • Aurora Denver Cardiology Associates
      • Denver, Colorado, Forenede Stater, 80218
        • Aurora Denver Cardiology Associates
    • Florida
      • Coral Gables, Florida, Forenede Stater, 33134
        • Clinical Research of South Florida
      • Defuniak Springs, Florida, Forenede Stater, 32435
        • Doctors Medical center of Walton County
      • Fort Lauderdale, Florida, Forenede Stater, 33316
        • Broward General Medical Center
      • Ft Lauderdale, Florida, Forenede Stater, 33316
        • Maxine Hamilton, MD, PA
      • Jacksonville, Florida, Forenede Stater, 32259
        • St John's Center for Clinical Research
      • Largo, Florida, Forenede Stater, 33773
        • Private Practice of Dr. Bridget Bellingar
      • Miami, Florida, Forenede Stater, 33155
        • AppleMed Research, Inc.
      • Miami, Florida, Forenede Stater, 33144
        • A + Research Inc.
      • N. Miami Beach, Florida, Forenede Stater, 33179
        • Internal Medicine Associates of South Florida
      • Ormond Beach, Florida, Forenede Stater, 32174
        • Ormond Medical Arts Pharmaceutical Research Center
      • Pensacola, Florida, Forenede Stater, 32514
        • Nothwest Florida Heart Group, PA-Research Dept
      • Sarasota, Florida, Forenede Stater, 34231
        • Cardiovascular Center of Sarasota
      • St Petersburg, Florida, Forenede Stater, 33701
        • Suncoast Cardiovascular Research, Inc
      • Tampa, Florida, Forenede Stater, 33603
        • Tampa Bay Nephrology Associates, PL
      • Tampa, Florida, Forenede Stater, 33607
        • Orlando Rangel, MD, PA
    • Georgia
      • Bogart, Georgia, Forenede Stater, 30622
        • AMR Research Associates, LLC
      • Tucker, Georgia, Forenede Stater, 30084
        • Atlanta Vascular Research Foundation
    • Illinois
      • Melrose Park, Illinois, Forenede Stater, 60160
        • Consultants in Cardiovascular Med (CIS)
      • Normal, Illinois, Forenede Stater, 61761
        • Illinois Heart & Lunch Research Center
      • Peoria, Illinois, Forenede Stater, 61606
        • Methodist Medical Center-Heart, Lung & Vascular Institute
    • Indiana
      • Muncie, Indiana, Forenede Stater, 47303
        • Medical Consultants, Pc
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40202
        • University Medical Associates
    • Louisiana
      • Lafayette, Louisiana, Forenede Stater, 70503
        • Dr. Jeffrey Chen
      • New Orleans, Louisiana, Forenede Stater, 70114
        • Louisiana Research Associates, Inc.
    • Maine
      • Auburn, Maine, Forenede Stater, 04210
        • Maine Research Associates
      • Biddeford, Maine, Forenede Stater, 04005
        • PrimeCare Internal Medicine
    • Michigan
      • Alpena, Michigan, Forenede Stater, 49707
        • Great Lakes Heart Center Of Alpena
      • Petoskey, Michigan, Forenede Stater, 49770
        • Internal Medicine of Northern Michigan
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55417
        • Minneapolis VAMC
      • St. Cloud, Minnesota, Forenede Stater, 56303
        • Central Minnesota Heart Center at St. Cloud Hospital
      • St. Paul, Minnesota, Forenede Stater, 55102
        • St. Paul Cardiology
    • Montana
      • Kalispell, Montana, Forenede Stater, 59901
        • Glacier View Cardiology, PC
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89106
        • Impact Clinical Trials
    • New Jersey
      • Linden, New Jersey, Forenede Stater, 07036
        • NJ Heart
      • Passaic, New Jersey, Forenede Stater, 07055
        • New Jersey Physicians
    • New York
      • Brooklyn, New York, Forenede Stater, 11214
        • Lifeline Research Institute
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28204
        • Metrolina Internal Medicine, PA
      • Charlotte, North Carolina, Forenede Stater, 28211
        • Heart Care Center of Charlotte
      • Winterville, North Carolina, Forenede Stater, 27858
        • Physicians East, PA
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73112
        • Plaza Medical Group, Pc
      • Tulsa, Oklahoma, Forenede Stater, 74136
        • Castlerock Clinical Research Consultants, Llc
    • Oregon
      • Ashland, Oregon, Forenede Stater, 97520
        • Integrated Medical Research PC
    • Rhode Island
      • Pawtucket, Rhode Island, Forenede Stater, 02860
        • Blackstone Cardiology Associates
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29403
        • Charleston Cardiology
      • Greenville, South Carolina, Forenede Stater, 29601
        • Paris View Family Practice
      • Greer, South Carolina, Forenede Stater, 29651
        • Internal Medicine Of Greer
    • Tennessee
      • Cleveland, Tennessee, Forenede Stater, 37311
        • Scenic City Research
    • Texas
      • Beaumont, Texas, Forenede Stater, 77702
        • Southeast Texas Clinical Research Center
      • Dallas, Texas, Forenede Stater, 75231
        • Cardiovascular Research Inst. of Dallas
      • Dallas, Texas, Forenede Stater, 75251
        • Galenos Research
      • El Paso, Texas, Forenede Stater, 79935
        • Sergio F Rovner, MD
      • Houston, Texas, Forenede Stater, 77008
        • Salim Gopalani, MD, PA
      • Houston, Texas, Forenede Stater, 77074
        • Clinical Trial Network
      • Houston, Texas, Forenede Stater, 77090
        • Houston Clinical Research Assoc.
      • Houston, Texas, Forenede Stater, 77055
        • Humayum Mirza, MD, PA
      • Hurst, Texas, Forenede Stater, 76054
        • Innovative Research of West Florida
      • Plano, Texas, Forenede Stater, 75093
        • North Texas Medical Research
      • Temple, Texas, Forenede Stater, 76508
        • Scott & White Memorial Hospital
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05401
        • Fletcher Allen Health Care/University of Vermont
    • Virginia
      • Hopewell, Virginia, Forenede Stater, 23860
        • Kamlesh N Dave Cardiology
    • West Virginia
      • Charleston, West Virginia, Forenede Stater, 25304
        • WVU Physicicans of Charleston
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 43717
        • Alpha Medical Research, Llc
      • Madison, Wisconsin, Forenede Stater, 53717
        • Executive Health and Research Associates

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

35 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

SELECTED INCLUSION CRITERIA:

  1. Subjects must be competent to provide written informed consent;
  2. Subjects must have completed the Maintenance Period of the DAR-312 study.

SELECTED EXCLUSION CRITERIA:

  1. Subjects who discontinue treatment with study drug prior to the end of the Maintenance Period in DAR-312 due to a study drug-related AE;
  2. Subjects who experience a study drug-related serious adverse event (SAE) during the DAR-312 study.

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Darusentan
Darusentan capsules titrated to an optimal dose of 50 mg, 100 mg, or 300 mg administered orally once daily
Medicin: Darusentan
Darusentan capsules at a dose of 50, 100, or 300 mg administered orally once daily
Andre navne:
  • LU 135252
Aktiv komparator: Guanfacine
Guanfacine 1 mg capsules administered orally once daily
Medicin: Guanfacine
Guanfacine 1 mg capsules administered orally once daily

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Ændring fra baseline i estimeret glomerulær filtrationshastighed (eGFR)
Tidsramme: Baseline til uge 14
Baseline til uge 14
Procentdel af forsøgspersoner, der når mål for systolisk blodtryk
Tidsramme: Uge 14
Uge 14
Ændring fra baseline i gennemsnitligt 24-timers systolisk og diastolisk ambulant blodtryk
Tidsramme: Baseline til uge 14
Baseline til uge 14

Sekundære resultatmål

Resultatmål
Tidsramme
Change from baseline in trough sitting systolic and diastolic blood pressures
Tidsramme: Baseline to Week 14
Baseline to Week 14

Samarbejdspartnere og efterforskere

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

Sponsor

Gilead Sciences

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. maj 2007

Primær færdiggørelse (Faktiske)

1. februar 2010

Studieafslutning (Faktiske)

1. maj 2010

Datoer for studieregistrering

Først indsendt

17. oktober 2006

Først indsendt, der opfyldte QC-kriterier

18. oktober 2006

Først opslået (Skøn)

19. oktober 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. januar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. januar 2014

Sidst verificeret

1. januar 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Protocol DAR-312-E

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 .

Kliniske forsøg med Forhøjet blodtryk

Kliniske forsøg med Darusentan

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Ukraine

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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