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Effects of Co-administration of Canagliflozin 300 mg and Phentermine 15 mg With Placebo in the Treatment of Non-Diabetic Overweight and Obese Participants

10. august 2016 opdateret af: Janssen Research & Development, LLC

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Safety and Efficacy of the Co-administration of Canagliflozin 300 mg and Phentermine 15 mg Compared With Placebo for the Treatment of Non-diabetic Overweight and Obese Subjects

The purpose of this study is to compare the effects of canagliflozin and phentermine to those of placebo to promote on a change in body weight over a 26 week period.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect), parallel-group, multicenter study of the effects of canagliflozin and phentermine co-administration in non-diabetic overweight or obese participants. The study will be conducted for about 33 weeks, approximately 344 participants will be randomly assigned in a 1:1:1:1 ratio to one of the four treatment groups: co-administration of canagliflozin and phentermine, canagliflozin alone, phentermine alone, or placebo. All participants will be also provided with diet and exercise counseling for weight loss (standardized non-pharmacological therapy).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

335

Fase

  • Fase 2

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
    • California
      • Walnut Creek, California, Forenede Stater
    • Florida
      • Jacksonville, Florida, Forenede Stater
    • Idaho
      • Meridian, Idaho, Forenede Stater
    • Indiana
      • Evansville, Indiana, Forenede Stater
    • Kentucky
      • Lexington, Kentucky, Forenede Stater
      • Louisville, Kentucky, Forenede Stater
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater
    • Massachusetts
      • Milford, Massachusetts, Forenede Stater
    • New York
      • Manlius, New York, Forenede Stater
    • Rhode Island
      • Warwick, Rhode Island, Forenede Stater
    • South Carolina
      • Mt Pleasant, South Carolina, Forenede Stater
    • Tennessee
      • Nashville, Tennessee, Forenede Stater
    • Texas
      • Dallas, Texas, Forenede Stater
      • Odessa, Texas, Forenede Stater
    • Virginia
      • Norfolk, Virginia, Forenede Stater
    • Wisconsin
      • Wauwatosa, Wisconsin, Forenede Stater

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 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Must have BMI >=30 kg/m2 and <50 kg/m2 at screening or BMI >=27 kg/m2 and <50 kg/m2 at screening in the presence of a comorbidity of hypertension and/or dyslipidemia
  • Must have stable weight, ie, change of < =5% in the 3 months before screening
  • Must agree to utilize a highly effective method of birth control

Exclusion Criteria:

  • An established diagnosis of diabetes mellitus
  • Has a history of obesity with a known secondary cause (eg, Cushing's disease/syndrome)
  • Has a history of hereditary glucose-galactose malabsorption or primary renal glycosuria
  • Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident within 12 weeks before screening
  • Has an Glycated hemoglobin (HBA1c) greater than or equal (>=) to 65 percent
  • An average of 3 seated blood pressure (BP) readings of systolic BP >= 160 mm Hg and/or Diastolic BP >= 100 millimeters of mercury at 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: Canagliflozin + Phentermine
300 mg capsule of Canagliflozin along with 15 mg capsule of Phentermine, taken once daily, orally for 26 weeks.
Medicin: Canagliflozin
300 mg capsule, taken once daily, orally for 26 weeks.
Andre navne:
  • INVOKANA
Medicin: Phentermine
15 mg capsule, taken once daily, orally for 26 weeks.
Eksperimentel: Canagliflozin + Placebo (Phentermine)
300 mg capsule of Canagliflozin along with matching placebo to Phentermine, taken once daily, orally for 26 weeks.
Medicin: Canagliflozin
300 mg capsule, taken once daily, orally for 26 weeks.
Andre navne:
  • INVOKANA
Medicin: Matching Placebo to Phentermine
Placebo capsules look like phentermine but do not contain any active drug, taken once daily, orally for 26 weeks.
Eksperimentel: Phentermine + Placebo (Canagliflozin)
15 mg capsule of Phentermine along with matching placebo to Canagliflozin, taken once daily, orally for 26 weeks.
Medicin: Phentermine
15 mg capsule, taken once daily, orally for 26 weeks.
Medicin: Matching Placebo to Canagliflozin
Placebo capsules look like canagliflozin but do not contain any active drug, taken once daily, orally for 26 weeks.
Placebo komparator: Placebo
Matching placebo to Canagliflozin and Phentermine, taken once daily, orally for 26 weeks.
Medicin: Matching Placebo to Phentermine
Placebo capsules look like phentermine but do not contain any active drug, taken once daily, orally for 26 weeks.
Medicin: Matching Placebo to Canagliflozin
Placebo capsules look like canagliflozin but do not contain any active drug, taken once daily, orally for 26 weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent Change From Baseline in Body Weight at Week 26
Tidsramme: Week 26
The percent change from baseline in body weight at Week 26 was analysed.
Week 26

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Weight Loss More Than Equal to (>=) 5 Percent at Week 26
Tidsramme: Week 26
Percentage of participants with weight loss >= 5 percent were analysed at week 26.
Week 26
Change From Baseline in Systolic Blood Pressure at Week 26
Tidsramme: Week 26
Change from baseline in systolic blood pressure was analysed at week 26.
Week 26
Absolute Change From Baseline in Body Weight at Week 26
Tidsramme: Week 26
Absolute change from baseline in body weight was analysed at week 26.
Week 26

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26
Tidsramme: Week 26
Change from baseline in diastolic blood pressure (DBP) at week 26.
Week 26
Change From Baseline in Pulse Rate at Week 26
Tidsramme: Week 26
Change from baseline in pulse rate at week 26
Week 26
Percentage of Participants With Weight Loss More Than Equal to (>=) 10 Percent at Week 26
Tidsramme: Week 26
Percentage of participants with weight loss >= 10 percent at week 26.
Week 26

Samarbejdspartnere og efterforskere

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

Sponsor

Janssen Research & Development, LLC

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. september 2014

Primær færdiggørelse (Faktiske)

1. juni 2015

Studieafslutning (Faktiske)

1. juni 2015

Datoer for studieregistrering

Først indsendt

16. september 2014

Først indsendt, der opfyldte QC-kriterier

16. september 2014

Først opslået (Skøn)

17. september 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. oktober 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. august 2016

Sidst verificeret

1. august 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CR103086
  • 28431754OBE2002 (Anden identifikator: Janssen Research & Development, LLC)

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 Canagliflozin

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Sponsorer og samarbejdspartnere

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CROs in United States

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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