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COREG MR Versus TOPROL-XL On Reduction Of Microalbuminuria In Patients With Hypertension And Microalbuminuria

16. januar 2017 opdateret af: GlaxoSmithKline

A Randomized, Double-blind, Positive-Controlled, Multicenter Study Comparing the Efficacy of Carvedilol Phosphate Modified Release Formulation (COREG MR) and Metoprolol Succinate Extended Release (TOPROL-XL) on the Reduction of Microalbuminuria in Patients With Hypertension and Microalbuminuria

This study was designed to determine whether COREG MR is more effective than TOPROL-XL in reducing microalbuminuria in type 2 diabetic or non-diabetic patients with high blood pressure and microalbuminuria.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding

1220

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2E 7C5
        • GSK Investigational Site
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W4
        • GSK Investigational Site
      • Vancouver, British Columbia, Canada, V7N 4M2
        • GSK Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • GSK Investigational Site
      • Winnipeg, Manitoba, Canada, R3K 0Y8
        • GSK Investigational Site
    • Newfoundland and Labrador
      • Bay Roberts, Newfoundland and Labrador, Canada, A0G 1G0
        • GSK Investigational Site
    • Ontario
      • Brampton, Ontario, Canada, L6T 3J1
        • GSK Investigational Site
      • Hamilton, Ontario, Canada, L8L 5G8
        • GSK Investigational Site
      • Kitchener, Ontario, Canada, N2G 1N9
        • GSK Investigational Site
      • London, Ontario, Canada, N5W 6A2
        • GSK Investigational Site
      • Stoney Creek, Ontario, Canada, L8G 2V6
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M9W 4L6
        • GSK Investigational Site
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada, C1A 5Y9
        • GSK Investigational Site
      • Montague, Prince Edward Island, Canada, C0A 1R0
        • GSK Investigational Site
    • Quebec
      • Bonaventure, Quebec, Canada, G0C 1E0
        • GSK Investigational Site
      • Mirabel, Quebec, Canada, J7J 2K8
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H2K 4L5
        • GSK Investigational Site
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • GSK Investigational Site
      • Saint-Romuald, Quebec, Canada, G6W 5M6
        • GSK Investigational Site
      • Trois Rivieres, Quebec, Canada, G8T 7A1
        • GSK Investigational Site
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35213
        • GSK Investigational Site
      • Mobile, Alabama, Forenede Stater, 36617
        • GSK Investigational Site
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85023
        • GSK Investigational Site
    • California
      • Fullerton, California, Forenede Stater, 92835
        • GSK Investigational Site
      • Inglewood, California, Forenede Stater, 90301
        • GSK Investigational Site
      • Los Angeles, California, Forenede Stater, 90057
        • GSK Investigational Site
      • Mission Viejo, California, Forenede Stater, 92691
        • GSK Investigational Site
      • Oakland, California, Forenede Stater, 94609
        • GSK Investigational Site
      • Redondo Beach, California, Forenede Stater, 90277
        • GSK Investigational Site
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater, 80919
        • GSK Investigational Site
    • Florida
      • Hollywood, Florida, Forenede Stater, 33023
        • GSK Investigational Site
      • Miami, Florida, Forenede Stater, 33156
        • GSK Investigational Site
      • Miami, Florida, Forenede Stater, 33169
        • GSK Investigational Site
      • Pembroke Pines, Florida, Forenede Stater, 33024
        • GSK Investigational Site
      • Sarasota, Florida, Forenede Stater, 34239
        • GSK Investigational Site
      • Tampa, Florida, Forenede Stater, 33614
        • GSK Investigational Site
    • Georgia
      • Decatur, Georgia, Forenede Stater, 30035
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • GSK Investigational Site
      • Chicago, Illinois, Forenede Stater, 60607
        • GSK Investigational Site
      • Melrose Park, Illinois, Forenede Stater, 60160
        • GSK Investigational Site
    • Indiana
      • Avon, Indiana, Forenede Stater, 46123
        • GSK Investigational Site
      • Elkhart, Indiana, Forenede Stater, 46515
        • GSK Investigational Site
      • Evansville, Indiana, Forenede Stater, 47714
        • GSK Investigational Site
      • Evansville, Indiana, Forenede Stater, 47713
        • GSK Investigational Site
      • Indianapolis, Indiana, Forenede Stater, 46250
        • GSK Investigational Site
      • Indianapolis, Indiana, Forenede Stater, 46254
        • GSK Investigational Site
    • Louisiana
      • Lafayette, Louisiana, Forenede Stater, 70503
        • GSK Investigational Site
    • Massachusetts
      • Ayer, Massachusetts, Forenede Stater, 01432
        • GSK Investigational Site
      • Worcester, Massachusetts, Forenede Stater, 01608
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89119
        • GSK Investigational Site
    • New Jersey
      • Voorhees, New Jersey, Forenede Stater, 08043
        • GSK Investigational Site
    • New York
      • Buffalo, New York, Forenede Stater, 14222
        • GSK Investigational Site
      • Camillus, New York, Forenede Stater, 13031
        • GSK Investigational Site
      • East Syracuse, New York, Forenede Stater, 13057
        • GSK Investigational Site
      • Kingston, New York, Forenede Stater, 12401
        • GSK Investigational Site
      • Port Chester, New York, Forenede Stater, 10573
        • GSK Investigational Site
      • Rochester, New York, Forenede Stater, 14618
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28211
        • GSK Investigational Site
      • Greensboro, North Carolina, Forenede Stater, 27401
        • GSK Investigational Site
      • Raleigh, North Carolina, Forenede Stater, 27609
        • GSK Investigational Site
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44130
        • GSK Investigational Site
      • Columbus, Ohio, Forenede Stater, 43210-1296
        • GSK Investigational Site
      • Kettering, Ohio, Forenede Stater, 45429
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73112
        • GSK Investigational Site
    • Oregon
      • Oregon City, Oregon, Forenede Stater, 97045
        • GSK Investigational Site
    • Pennsylvania
      • Beaver, Pennsylvania, Forenede Stater, 15009
        • GSK Investigational Site
      • Havertown, Pennsylvania, Forenede Stater, 19083
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19152
        • GSK Investigational Site
      • Reading, Pennsylvania, Forenede Stater, 19601
        • GSK Investigational Site
      • West Grove, Pennsylvania, Forenede Stater, 19390
        • GSK Investigational Site
    • Rhode Island
      • East Providence, Rhode Island, Forenede Stater, 02914
        • GSK Investigational Site
    • South Carolina
      • Greer, South Carolina, Forenede Stater, 29651
        • GSK Investigational Site
      • Orangeburg, South Carolina, Forenede Stater, 29118
        • GSK Investigational Site
    • Tennessee
      • Johnson City, Tennessee, Forenede Stater, 37604
        • GSK Investigational Site
    • Texas
      • Beaumont, Texas, Forenede Stater, 77701
        • GSK Investigational Site
      • Dallas, Texas, Forenede Stater, 75231
        • GSK Investigational Site
      • Dallas, Texas, Forenede Stater, 75390-9068
        • GSK Investigational Site
      • Fort Worth, Texas, Forenede Stater, 76104
        • GSK Investigational Site
      • Galveston, Texas, Forenede Stater, 77555-0188
        • GSK Investigational Site
      • Houston, Texas, Forenede Stater, 77030
        • GSK Investigational Site
      • Houston, Texas, Forenede Stater, 77024
        • GSK Investigational Site
      • Midland, Texas, Forenede Stater, 79705
        • GSK Investigational Site
      • San Antonio, Texas, Forenede Stater, 78229
        • GSK Investigational Site
      • San Antonio, Texas, Forenede Stater, 78216
        • GSK Investigational Site
    • Virginia
      • Burke, Virginia, Forenede Stater, 22015
        • GSK Investigational Site
      • Springfield, Virginia, Forenede Stater, 22151
        • GSK Investigational Site
    • Washington
      • Edmonds, Washington, Forenede Stater, 98026
        • GSK Investigational Site
      • Olympia, Washington, Forenede Stater, 98502
        • GSK Investigational Site
      • Spokane, Washington, Forenede Stater, 99208
        • GSK Investigational Site
      • Spokane, Washington, Forenede Stater, 99207
        • GSK Investigational Site
      • Spokane, Washington, Forenede Stater, 99206
        • GSK Investigational Site
      • Wenatchee, Washington, Forenede Stater, 98801
        • GSK Investigational Site
  • Puerto Rico
      • Rio Grande, Puerto Rico, 00745
        • GSK Investigational Site
      • San Juan, Puerto Rico, 00907
        • GSK Investigational Site

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 til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

  • Documented history of hypertension.
  • Must have been taking an ACE (angiotensin converting enzyme) inhibitor either alone or as part of an antihypertensive regimen for at least 8 weeks.
  • Persistent microalbuminuria.

Exclusion criteria:

  • History of heart attack, stroke, congestive heart failure, arrhythmia, type 1 or uncontrolled type 2 diabetes mellitus, liver or renal disease.
  • Has been taking any non-ocular beta-blockers for any indication within three months prior to Pre-screening.

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: Dobbelt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change from baseline in urine albumin: creatinine ratio (ACR) at six months of maintenance therapy.
Tidsramme: Baseline (Randomization Visit) and Month 6
Baseline (Randomization Visit) and Month 6

Sekundære resultatmål

Resultatmål
Tidsramme
Percentage of participants who achieved normoalbuminuria at 6 months of maintenance therapy.
Tidsramme: Month 6
Month 6
Percentage of participants who progressed to macroalbuminuria after 6 months of maintenance therapy.
Tidsramme: Month 6
Month 6
Change from baseline to month 6 LOCF in High-sensitivity C-reactive protein (hs-CRP)
Tidsramme: Baseline (Randomization Visit) and Month 6
Baseline (Randomization Visit) and Month 6
Change from Pre-screening visit to month 6 LOCF in urine ACR.
Tidsramme: Pre-screening Visit and Month 6
Pre-screening Visit and Month 6
Change from baseline to visit to month 6 LOCF in lipids including total cholesterol, low density lipid (LDL), high density lipid (HDL) and Triglycerides (TG)
Tidsramme: Baseline (Randomization visit) and Month 6
Baseline (Randomization visit) and Month 6
Changes from baseline in blood pressure (systolic and diastolic) at month 6 of treatment.
Tidsramme: Baseline (Randomization Visit) and Month 6
Baseline (Randomization Visit) and Month 6
Changes from baseline in heart rate at month 6 of treatment.
Tidsramme: Baseline (Randomization visit) and Month 6
Baseline (Randomization visit) and Month 6
Percentage of participants who required add-on therapy to reach target blood pressure at any time during the study.
Tidsramme: Up to 6 months
Up to 6 months
Number of participants with clinical chemistry parameters and hematology parameters of potential clinical concern at any time on-treatment.
Tidsramme: Up to 6 months
Up to 6 months
Number of participants with vital signs of potential clinical concern at any time on-treatment.
Tidsramme: Up to 6 months
Up to 6 months

Samarbejdspartnere og efterforskere

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

Sponsor

GlaxoSmithKline

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 2005

Primær færdiggørelse (Faktiske)

1. maj 2006

Studieafslutning (Faktiske)

1. maj 2006

Datoer for studieregistrering

Først indsendt

22. juli 2005

Først indsendt, der opfyldte QC-kriterier

25. juli 2005

Først opslået (Skøn)

26. juli 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. januar 2017

Sidst verificeret

1. januar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • COR103560

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Studiedata/dokumenter

  1. Formular til informeret samtykke
    Informations-id: COR103560
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Klinisk undersøgelsesrapport
    Informations-id: COR103560
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Datasætspecifikation
    Informations-id: COR103560
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistisk analyseplan
    Informations-id: COR103560
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Annoteret sagsbetænkningsformular
    Informations-id: COR103560
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Studieprotokol
    Informations-id: COR103560
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Individuelt deltagerdatasæt
    Informations-id: COR103560
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register

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 .

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Sponsorer og samarbejdspartnere

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Betingelser

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Narkotikainterventioner

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Sponsor / samarbejdspartnere

Placeringer

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