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Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)

18. marts 2013 opdateret af: Forest Laboratories

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years) Who Have Stage 1 or 2 Essential Hypertension

The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with stage 1 or stage 2 essential hypertension.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

641

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
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85014
        • Forest Investigative Site 065
      • Phoenix, Arizona, Forenede Stater, 85014
        • Forest Investigative Site 067
      • Phoenix, Arizona, Forenede Stater, 85014
        • Forest Investigative Site 070
    • California
      • Buena Park, California, Forenede Stater, 90620
        • Forest Investigative Site 049
      • Burbank, California, Forenede Stater, 91505
        • Forest Investigative Site 034
      • Costa Mesa, California, Forenede Stater, 92626
        • Forest Investigative Site 039
      • Fountain Valley, California, Forenede Stater, 92708
        • Forest Investigative Site 024
      • Fresno, California, Forenede Stater, 93726
        • Forest Investigative Site 020
      • Fresno, California, Forenede Stater, 93726
        • Forest Investigative Site 021
      • Greenbrae, California, Forenede Stater, 94904
        • Forest Investigative Site 040
      • La Mesa, California, Forenede Stater, 91942
        • Forest Investigative Site 047
      • Los Angeles, California, Forenede Stater, 90057
        • Forest Investigative Site 073
      • Roseville, California, Forenede Stater, 95661
        • Forest Investigative Site 077
      • San Bernardino, California, Forenede Stater, 92404
        • Forest Investigative Site 060
      • San Francisco, California, Forenede Stater, 94115
        • Forest Investigative Site 054
      • Spring Valley, California, Forenede Stater, 91978
        • Forest Investigative Site 018
    • Colorado
      • Denver, Colorado, Forenede Stater, 80220
        • Forest Investigative Site 028
    • Florida
      • Brooksville, Florida, Forenede Stater, 34601
        • Forest Investigative Site 059
      • Ft. Lauderdale, Florida, Forenede Stater, 33306
        • Forest Investigative Site 033
      • Hallandale Beach, Florida, Forenede Stater, 33009
        • Forest Investigative Site 006
      • Longwood, Florida, Forenede Stater, 32779
        • Forest Investigative Site 044
      • Miami, Florida, Forenede Stater, 33014
        • Forest Investigative Site 001
      • Miami, Florida, Forenede Stater, 33014
        • Forest Investigative Site 012
      • Miami, Florida, Forenede Stater, 33014
        • Forest Investigative Site 032
      • Miami, Florida, Forenede Stater, 33014
        • Forest Investigative Site 055
      • Oviedo, Florida, Forenede Stater, 32765
        • Forest Investigative Site 045
      • St. Petersburg, Florida, Forenede Stater, 33709
        • Forest Investigative Site 031
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30084
        • Forest Investigative Site 009
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Forest Investigative Site 007
      • Morton, Illinois, Forenede Stater, 61550
        • Forest Investigative Site 004
    • Indiana
      • Evansville, Indiana, Forenede Stater, 47713
        • Forest Investigative Site 072
      • Newburgh, Indiana, Forenede Stater, 47630
        • Forest Investigative Site 069
    • Kansas
      • Augusta, Kansas, Forenede Stater, 67010
        • Forest Investigative Site 025
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40213
        • Forest Investigative Site 029
      • Madisonville, Kentucky, Forenede Stater, 42431
        • Forest Investigative Site 068
    • Louisiana
      • Metairie, Louisiana, Forenede Stater, 70005
        • Forest Investigative Site 061
      • New Orleans, Louisiana, Forenede Stater, 70119
        • Forest Investigative Site 057
      • New Orleans, Louisiana, Forenede Stater, 70119
        • Forest Investigative Site 058
    • Maryland
      • Lutherville, Maryland, Forenede Stater, 21093
        • Forest Investigative Site 008
    • Massachusetts
      • Fall River, Massachusetts, Forenede Stater, 02702
        • Forest Investigative Site 062
    • Michigan
      • Paw Paw, Michigan, Forenede Stater, 49079
        • Forest Investigative Site 075
    • Minnesota
      • Brooklyn Center, Minnesota, Forenede Stater, 55430
        • Forest Investigative Site 019
      • Chaska, Minnesota, Forenede Stater, 55318
        • Forest Investigative Site 017
    • Mississippi
      • Belzoni, Mississippi, Forenede Stater, 39038
        • Forest Investigative Site 038
      • Olive Branch, Mississippi, Forenede Stater, 38654
        • Forest Investigative Site 035
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89101
        • Forest Investigative Site 023
      • Las Vegas, Nevada, Forenede Stater, 89101
        • Forest Investigative Site 048
      • Las Vegas, Nevada, Forenede Stater, 89101
        • Forest Investigative Site 052
    • New Jersey
      • Elizabeth, New Jersey, Forenede Stater, 27609
        • Forest Investigative Site 014
      • Trenton, New Jersey, Forenede Stater, 08611
        • Forest Investigative Site 051
    • North Carolina
      • Asheboro, North Carolina, Forenede Stater, 27203
        • Forest Investigative Site 003
      • Charlotte, North Carolina, Forenede Stater, 28277
        • Forest Investigative Site 010
      • Raleigh, North Carolina, Forenede Stater, 27609
        • Forest Investigative Site 011
      • Raleigh, North Carolina, Forenede Stater, 27609
        • Forest Investigative Site 016
      • Wilmington, North Carolina, Forenede Stater, 28401
        • Forest Investigative Site 005
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Forest Investigative Site 036
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43213
        • Forest Investigative Site 002
    • Oklahoma
      • Norman, Oklahoma, Forenede Stater, 73069
        • Forest Investigative Site 050
    • Oregon
      • Portland, Oregon, Forenede Stater, 33709
        • Forest Investigative Site 030
    • Pennsylvania
      • Downingtown, Pennsylvania, Forenede Stater, 19335
        • Forest Investigative Site 056
    • South Carolina
      • Pelzer, South Carolina, Forenede Stater, 29669
        • Forest Investigative Site 022
    • Texas
      • Beaumont, Texas, Forenede Stater, 77701
        • Forest Investigative Site 053
      • Boerne, Texas, Forenede Stater, 78006
        • Forest Investigative Site 066
      • Corpus Christi, Texas, Forenede Stater, 78404
        • Forest Investigative Site 076
      • Dallas, Texas, Forenede Stater, 75234
        • Forest Investigative Site 037
      • Haltom City, Texas, Forenede Stater, 84070
        • Forest Investigative Site 043
      • Houston, Texas, Forenede Stater, 77081
        • Forest Investigative Site 026
      • Houston, Texas, Forenede Stater, 77081
        • Forest Investigative Site 027
      • Houston, Texas, Forenede Stater, 77081
        • Forest Investigative Site 015
      • Houston, Texas, Forenede Stater, 77081
        • Forest Investigative Site 074
    • Utah
      • Orem, Utah, Forenede Stater, 84058
        • Forest Investigative Site 071
      • Sandy, Utah, Forenede Stater, 84070
        • Forest Investigative Site 042
    • Virginia
      • Norfolk, Virginia, Forenede Stater, 23502
        • Forest Investigative Site 063
      • Norfolk, Virginia, Forenede Stater, 23502
        • Forest Investigative Site 064
    • Washington
      • Port Orchard, Washington, Forenede Stater, 98366
        • Forest Investigative Site 046

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 54 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Male and female outpatients, of age 18 - 54 years
  • Patients diagnosed with stage 1 or stage 2 essential hypertension
  • Normal physical examination findings and electrocardiogram (ECG) results or abnormal findings judged by the Investigator to be not clinically significant

Exclusion Criteria:

  • Secondary hypertension or severe hypertension
  • History of Type 1 diabetes mellitus
  • A medical contraindication to discontinuing a current antihypertensive therapy
  • Clinically significant respiratory disease that prohibit use of a beta blocker

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
Medicin: Nebivolol
Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
Placebo komparator: 2
Dose-matched placebo
Medicin: Placebo
Dose-match placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Trough Seated Diastolic Blood Pressure (DBP)
Tidsramme: Change from Baseline to Week 8
Change from baseline in mean seated trough cuff Diastolic Blood Pressure (DBP) at Week 8 as measured by an Omron device. The primary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.
Change from Baseline to Week 8

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Trough Seated Systolic Blood Pressure (SBP)
Tidsramme: Change from Baseline to Week 8
Change from baseline in mean seated trough cuff Systolic Blood Pressure (SBP) at Week 8 as measured by an Omron device. The secondary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.
Change from Baseline to Week 8

Samarbejdspartnere og efterforskere

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

Sponsor

Forest Laboratories

Efterforskere

  • Studieleder: Tatjana Lukic, MD, M. Sc., Forest Laboratories

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. august 2011

Primær færdiggørelse (Faktiske)

1. marts 2012

Studieafslutning (Faktiske)

1. april 2012

Datoer for studieregistrering

Først indsendt

10. august 2011

Først indsendt, der opfyldte QC-kriterier

11. august 2011

Først opslået (Skøn)

12. august 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. maj 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. marts 2013

Sidst verificeret

1. marts 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NEB-MD-28

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 Nebivolol

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Liberia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner