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

30. juni 2011 oppdatert av: 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

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

231

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Legemiddel: 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 navn:
  • 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
Legemiddel: 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
Legemiddel: HCTZ
  • HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration
  • HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration
Andre navn:
  • Hydrochlorothorazide

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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)]

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Forest Laboratories

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2008

Primær fullføring (Faktiske)

1. juli 2010

Datoer for studieregistrering

Først innsendt

27. august 2008

Først innsendt som oppfylte QC-kriteriene

28. august 2008

Først lagt ut (Anslag)

29. august 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

29. juli 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. juni 2011

Sist bekreftet

1. juni 2011

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NEB-MD-19

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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