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Study of the Glycemic Effects of Nebivolol Compared With Metoprolol and HCTZ in Diabetic Hypertensive Patients

30. juni 2011 opdateret af: Forest Laboratories

Glycemic Effects of Nebivolol Compared With Metoprolol Extended Release and Compared With Hydrochlorothiazide In Hypertensive Patients With Type 2 Diabetes Mellitus: A Pilot Study

This study will evaluate the effects of nebivolol on glycemic control compared with metoprolol and HCTZ in patients with hypertension and type 2 diabetes mellitus

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

231

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
      • Athens, Alabama, Forenede Stater, 35611
        • Forest Investigative Site 15
      • Huntsville, Alabama, Forenede Stater, 35801
        • Forest Investigative Site 16
    • California
      • Bell Gardens, California, Forenede Stater, 90201
        • Forest Investigative Site 35
      • Buena Park, California, Forenede Stater, 90620
        • Forest Investigative Site
      • Chino, California, Forenede Stater, 91710
        • Forest Investigative Site 54
      • Fremont, California, Forenede Stater, 94538
        • Forest Investigative Site 40
      • Palm Springs, California, Forenede Stater, 92262
        • Forest Investigative Site
      • Pomona, California, Forenede Stater, 91767
        • Forest Investigative Site
      • Sacramento, California, Forenede Stater, 95821
        • Forest Investigative Site 55
      • San Diego, California, Forenede Stater, 92128
        • Forest Investigative Site 11
      • Santa Monica, California, Forenede Stater, 90404
        • Forest Investigative Site
      • Spring Valley, California, Forenede Stater, 91978
        • Forest Investigative Site
      • Tustin, California, Forenede Stater, 92780
        • Forest Investigative Site 49
      • Walnut Creek, California, Forenede Stater, 94598
        • Forest Investigative Site 47
    • Colorado
      • Golden, Colorado, Forenede Stater, 80401
        • Forest Investigative Site 61
      • Wheat Ridge, Colorado, Forenede Stater, 80033
        • Forest Investigative Site
    • Florida
      • Daytona Beach, Florida, Forenede Stater, 32117
        • Forest Investigative Site 3
      • DeLand, Florida, Forenede Stater, 32720
        • Forest Investigative Site 33
      • Hollywood, Florida, Forenede Stater, 33023
        • Forest Investigative Site 36
      • Miami, Florida, Forenede Stater, 33135
        • Forest Investigative Site 62
      • Miami, Florida, Forenede Stater, 33169
        • Forest Investigative Site 080
      • Miami, Florida, Forenede Stater, 33183
        • Forest Investigative Site 59
      • Pembroke Pines, Florida, Forenede Stater, 33024
        • Forest Investigative Site 32
      • Pembroke Pines, Florida, Forenede Stater, 33028
        • Forest Investigative Site 081
      • Tamarac, Florida, Forenede Stater, 33321
        • Forest Investigative Site 2
      • Tampa, Florida, Forenede Stater, 33612
        • Forest Investigative Site
      • West Palm Beach, Florida, Forenede Stater, 33401
        • Forest Investigative Site 19
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30312
        • Forest Investigative Site 44
      • Augusta, Georgia, Forenede Stater, 30904
        • Forest Investigative Site 5
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96814
        • Forest Investigative Site 56
    • Idaho
      • Meridian, Idaho, Forenede Stater, 83646
        • Forest Investigative Site 57
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60607
        • Forest Investigative Site 39
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67203
        • Forest Investigative Site 37
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21204
        • Forest Investigative Site
      • Baltimore, Maryland, Forenede Stater, 21209
        • Forest Investigative Site 20
      • Oxon Hill, Maryland, Forenede Stater, 20745
        • Forest Investigative Site 50
    • Michigan
      • St. Clair Shores, Michigan, Forenede Stater, 48081
        • Forest Investigative Site 21
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64111
        • Forest Investigative Site
      • St. Louis, Missouri, Forenede Stater, 63110
        • Forest Investigative Site
    • New York
      • New Hyde Park, New York, Forenede Stater, 11042
        • Forest Investigative Site
      • New York, New York, Forenede Stater, 10032
        • Forest Investigative Site
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28211
        • Forest Investigative Site 7
      • Charlotte, North Carolina, Forenede Stater, 28262
        • Forest Investigative Site 45
      • Morehead City, North Carolina, Forenede Stater, 28557
        • Forest Investigative Site 24
      • Salisbury, North Carolina, Forenede Stater, 28144
        • Forest Investigative Site 26
      • Wilmington, North Carolina, Forenede Stater, 28401
        • Forest Investigative Site 18
    • Ohio
      • Centerville, Ohio, Forenede Stater, 45459
        • Forest Investigative Site 51
      • Cincinnati, Ohio, Forenede Stater, 45242
        • Forest Investigative Site 48
      • Wadsworth, Ohio, Forenede Stater, 44281
        • Forest Investigative Site 12
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29407
        • Forest Investigative Site 17
      • Columbia, South Carolina, Forenede Stater, 29201
        • Forest Investigative Site 46
      • North Charleston, South Carolina, Forenede Stater, 29406
        • Forest Investigative Site
      • Simpsonville, South Carolina, Forenede Stater, 29681
        • Forest Investigative Site
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57104
        • Forest Investigative Site 4
    • Tennessee
      • New Tazewell, Tennessee, Forenede Stater, 37825
        • Forest Investigative Site 10
    • Texas
      • Corpus Christi, Texas, Forenede Stater, 78404
        • Forest Investigative Site 52
      • Dallas, Texas, Forenede Stater, 75390
        • Forest Investigative Site 28
      • Hurst, Texas, Forenede Stater, 76054
        • Forest Investigative Site 38
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84102
        • Forest Investigative Site 34
      • St. George, Utah, Forenede Stater, 84790
        • Forest Investigative Site
    • Virginia
      • Norfolk, Virginia, Forenede Stater, 23502
        • Forest Investigative Site
      • Virginia Beach, Virginia, Forenede Stater, 23452
        • Forest Investigative Site 31
  • Puerto Rico
      • Ponce, Puerto Rico, 00717
        • Forest Investigative Site 41
      • Salinas, Puerto Rico, 00751
        • Forest Investigative Site 60
      • Santurce, Puerto Rico, 00909
        • Forest Investigative Site 29

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 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

INCLUSION CRITERIA:

  • Male or female, 18-85 years of age
  • Blood pressure in the range of 130 to 179/80 to 109 mmHg
  • Currently using either an ACE inhibitor or an ARB alone or (an ACE inhibitor or an ARB and up to two other drugs for treatment of high blood pressure). (Patients may be on both an ACE inhibitor and ARB, but would need to be taken off one.)
  • Stable medication regimen for high blood pressure for at least one month prior to screening
  • Stable type 2 diabetes mellitus for at least 3 months prior to screening that is controlled by any or all of the following: diet and antidiabetic medications that may include fixed-dose insulin
  • HgbA1c 6.5 to 8.5% (This is measured at the screening visit)

EXCLUSION CRITERIA:

  • Use of any beta blocker within one month prior to screening
  • Use of clonidine within 3 months prior to screening
  • Diagnosis of hyperthyroidism as evidenced by abnormal lab markers
  • Any disorder requiring the intermittent or chronic use of systemic corticosteroids
  • Diagnosis of hyperthyroidism as determined by lab markers done at screening
  • Active liver disease as determined by lab markers
  • Kidney impairment; estimated GFR < 60 mL/min/1.73 m2
  • History of heart attack, clinically significant arrhythmia, unstable angina, coronary angioplasty/bypass surgery, stroke, or TIA in 3 months prior to screening
  • Chronic heart failure
  • Drug or alcohol abuse within 2 years prior to screening
  • History of sensitivity to any beta blocker, HCTZ, sulfa drug, or calcium channel blocker
  • Participation in another research study within 30 days prior to 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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
  • Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration
  • Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration
  • Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration
  • Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration
  • Open-label amlodipine may be given
Medicin: Nebivolol
  • Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration
  • Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration
  • Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration
  • Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration
Andre navne:
  • Bystolisk (TM)
Aktiv komparator: 2
  • Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration
  • Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration
  • Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration
  • Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration
  • Open-label amlodipine may be given
Medicin: Metoprolol ER
  • Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration
  • Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration
  • Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration
  • Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration
Aktiv komparator: 3
  • HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration
  • HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration
  • Open-label amlodipine may be given
Medicin: HCTZ
  • HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration
  • HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration
Andre navne:
  • Hydrochlorothorazide

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at Week 26
Tidsramme: visit 5(week 0) and visit 14(week 26)
Change from baseline in glycosylated hemoglobin (HbA1c) over 26 weeks, Last Observation Carried Forward.
visit 5(week 0) and visit 14(week 26)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Tidsramme: [visit 5(week 0) and visit 14(week 26)]
Change from Baseline in Insulin Resistance based on homeostasis model assessment of insulin resistance (HOMA-IR) at week 26, Last Observation Carried Forward (LOCF). The HOMA-IR is the the product of the blood Glucose and Insulin levels, divided by a constant. HOMA-IR is expressed as the following: HOMA-IR = fasting serum insulin (μU/ml) × fasting plasma glucose (mmol/l) / 22.5
[visit 5(week 0) and visit 14(week 26)]

Samarbejdspartnere og efterforskere

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

Sponsor

Forest Laboratories

Efterforskere

  • Studieleder: John Shea, MS, Forest Research Institute, a Subsidiary of Forest Laboratories, Inc.

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 2008

Primær færdiggørelse (Faktiske)

1. juli 2010

Datoer for studieregistrering

Først indsendt

27. august 2008

Først indsendt, der opfyldte QC-kriterier

28. august 2008

Først opslået (Skøn)

29. august 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. juli 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juni 2011

Sidst verificeret

1. juni 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NEB-MD-19

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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