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Evaluation of Blood Pressure Reduction, Safety, and Tolerability of Canagliflozin in Patients With Hypertension and Type 2 Diabetes Mellitus on Stable Doses of Anti-hyperglycemic and Anti-hypertensive Agents

2. marts 2017 opdateret af: Janssen Scientific Affairs, LLC

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Blood Pressure Reduction With Ambulatory Blood Pressure Monitoring (ABPM), Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Hypertension and Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the effect of canagliflozin (JNJ-28431754) on blood pressure reduction, compared to placebo, in patients with hypertension and type 2 diabetes mellitus and who are on stable doses of anti-hyperglycemic and anti-hypertensive agents. Overall safety and tolerability of canagliflozin will be assessed.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a randomized (study drug assigned by chance), double blind (neither the patient nor the study doctor will know the name of the assigned treatment), parallel-group, 3-arm (patients will be assigned to 1 of 3 treatment groups) multicenter study to determine the effect of canagliflozin (100 mg and 300 mg) on blood pressure (BP) reduction compared to placebo (a pill that looks like all the other treatments but has no real medicine) in patients with hypertension and type 2 diabetes mellitus (T2DM). The study will consist of 3 phases: a screening phase, a double-blind treatment phase and a follow-up period. Approximately 153 participants will be randomly assigned to 1 of 3 treatment groups (in a 1:1:1 ratio) in the double-blind treatment phase to receive canagliflozin 100 mg, canagliflozin 300 mg or placebo for 6 weeks. The total duration of participation in this study will be approximately 13 weeks.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

171

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
      • Birmingham, Alabama, Forenede Stater
      • Gulf Shores, Alabama, Forenede Stater
    • Arizona
      • Avondale, Arizona, Forenede Stater
      • Phoenix, Arizona, Forenede Stater
    • California
      • Glendale, California, Forenede Stater
      • Los Angeles, California, Forenede Stater
      • Newport Beach, California, Forenede Stater
      • Pismo Beach, California, Forenede Stater
      • Rancho Cucamonga, California, Forenede Stater
      • Roseville, California, Forenede Stater
      • Sacramento, California, Forenede Stater
      • Spring Valley, California, Forenede Stater
      • Tustin, California, Forenede Stater
    • Colorado
      • Denver, Colorado, Forenede Stater
    • Florida
      • Brandon, Florida, Forenede Stater
      • Doral, Florida, Forenede Stater
      • Fort Lauderdale, Florida, Forenede Stater
      • Lake Worth, Florida, Forenede Stater
      • Lauderdale Lakes, Florida, Forenede Stater
      • Miami, Florida, Forenede Stater
      • Miami Lakes, Florida, Forenede Stater
      • Orlando, Florida, Forenede Stater
      • Pembroke Pines, Florida, Forenede Stater
      • Port Orange, Florida, Forenede Stater
      • West Palm Beach, Florida, Forenede Stater
    • Georgia
      • Perry, Georgia, Forenede Stater
      • Rincon, Georgia, Forenede Stater
    • Indiana
      • Indianapolis, Indiana, Forenede Stater
    • Kansas
      • Topeka, Kansas, Forenede Stater
    • Kentucky
      • Lexington, Kentucky, Forenede Stater
    • Louisiana
      • Mandeville, Louisiana, Forenede Stater
      • Marrero, Louisiana, Forenede Stater
      • Metairie, Louisiana, Forenede Stater
    • Maine
      • Auburn, Maine, Forenede Stater
    • Maryland
      • Elkridge, Maryland, Forenede Stater
    • Michigan
      • Dearborn, Michigan, Forenede Stater
      • Kalamazoo, Michigan, Forenede Stater
    • Mississippi
      • Jackson, Mississippi, Forenede Stater
    • Missouri
      • St. Louis, Missouri, Forenede Stater
    • New Jersey
      • Morganville, New Jersey, Forenede Stater
      • Whiting, New Jersey, Forenede Stater
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater
    • North Carolina
      • Raleigh, North Carolina, Forenede Stater
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater
    • Pennsylvania
      • Altoona, Pennsylvania, Forenede Stater
      • Jenkintown, Pennsylvania, Forenede Stater
    • Tennessee
      • Nashville, Tennessee, Forenede Stater
    • Texas
      • Austin, Texas, Forenede Stater
      • Dallas, Texas, Forenede Stater
      • Houston, Texas, Forenede Stater
      • Plano, Texas, Forenede Stater
      • Sugar Land, Texas, Forenede Stater
    • Utah
      • Salt Lake City, Utah, Forenede Stater
    • Washington
      • Renton, Washington, Forenede Stater
  • Puerto Rico
      • Carolina, Puerto Rico
      • Ponce Pr, Puerto Rico
      • Trujillo Alto, Puerto Rico

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 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • patients with a diagnosis of type 2 diabetes mellitus
  • patients with hypertension (seated office SBP of >=130 mmHg and <160 mmHg and seated office DBP of >= 70 mmHg at screening and at Week -2
  • patients on stable doses of 1 to 3 anti-hypertensive agents for at least 5 weeks before screening
  • patients on stable doses of 1 to 3 oral anti-hyperglycemic agents which must include metformin, for at least 8 weeks before screening

Exclusion Criteria:

  • a history of diabetic ketoacidosis
  • type 1 diabetes mellitus (T1DM)
  • pancreas or beta-cell transplantation
  • fasting C-peptide <0.70 ng/mL (0.23 nmol/L)
  • body mass index <30 kg/m2
  • has ongoing, inadequately controlled thyroid disorder
  • has a history of cardio-renal disease that required treatment with immunosuppressive therapy.

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Canagliflozin 100 mg
Each patient will receive 100 mg of canagliflozin once daily for 6 weeks.
Medicin: Canagliflozin
One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) in addition to the patient's anti-hyperglycemic agents (AHA) regimen used in accordance with local prescribing information.
Eksperimentel: Canagliflozin 300 mg
Each patient will receive 300 mg of canagliflozin once daily for 6 weeks.
Medicin: Canagliflozin
One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) in addition to the patient's anti-hyperglycemic agents (AHA) regimen used in accordance with local prescribing information.
Placebo komparator: Placebo
Each patient will receive matching placebo once daily for 6 weeks.
Medicin: Placebo
One matching placebo capsule orally in addition to the patient's anti-hyperglycemic agents (AHA) regimen used in accordance with local prescribing information.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to Week 6
Tidsramme: Baseline and Week 6
The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Baseline and Week 6

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Mean 24-Hour Systolic Blood Pressure (SBP) to Day 2
Tidsramme: Baseline and Day 2
The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Baseline and Day 2
Change From Baseline in the Mean 24-Hour Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
Tidsramme: Baseline, Day 2 and Week 6
The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Baseline, Day 2 and Week 6
Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) to Day 2 and to Week 6
Tidsramme: Baseline, Day 2 and Week 6
The diurnal rise (daytime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Baseline, Day 2 and Week 6
Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
Tidsramme: Baseline, Day 2 and Week 6
The diurnal rise (daytime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Baseline, Day 2 and Week 6
Change From Baseline in Mean Nighttime Systolic Blood Pressure (SBP) to Day 2 and to Week 6
Tidsramme: Baseline, Day 2 and Week 6
The nocturnal fall (nighttime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Baseline, Day 2 and Week 6
Change From Baseline in Mean Nighttime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
Tidsramme: Baseline, Day 2 and Week 6
The nocturnal fall (nighttime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Baseline, Day 2 and Week 6
Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6
Tidsramme: Baseline and Week 6
The fasting plasma glucose was evaluated.
Baseline and Week 6
Change From Baseline in Body Weight to Week 6
Tidsramme: Baseline and Week 6
Body weight was evaluated.
Baseline and Week 6
Change From Baseline in Seated Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
Tidsramme: Baseline, Day 2, Week 3 and 6
The seated office blood pressure (BP) was evaluated for all participants based on the 24-hour BP recordings. SBP=Systolic Blood Pressure and DBP=Diastolic Blood Pressure.
Baseline, Day 2, Week 3 and 6
Change From Baseline in Standing Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
Tidsramme: Baseline, Day 2, Week 3 and 6
The standing office blood pressure (BP) was evaluated for all participants based on the 24-hour BP recordings. SBP=Systolic Blood Pressure and DBP=Diastolic Blood Pressure.
Baseline, Day 2, Week 3 and 6
Change From Baseline in Seated Heart Rate (HR) to Day 2, to Week 3, and to Week 6
Tidsramme: Baseline, Day 2, Week 3 and 6
The seated heart rate was evaluated.
Baseline, Day 2, Week 3 and 6
Change From Baseline in Standing Heart Rate (HR) to Day 2, to Week 3, and to Week 6
Tidsramme: Baseline, Day 2, Week 3 and 6
The standing heart rate was evaluated.
Baseline, Day 2, Week 3 and 6
Change From Baseline in the Difference in Seated Office Blood Pressure (BP) and Standing Office BP to Day 2, to Week 3, and to Week 6
Tidsramme: Baseline, Day 2, Week 3 and 6
The difference in seated office blood pressure and standing office blood pressure was evaluated.
Baseline, Day 2, Week 3 and 6
Change From Baseline in the Difference in Seated Heart Rate (HR) and Standing HR to Day 2, to Week 3, and to Week 6
Tidsramme: Baseline, Day 2, Week 3 and 6
The difference in seated heart rate and standing heart rate was evaluated.
Baseline, Day 2, Week 3 and 6

Samarbejdspartnere og efterforskere

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

Sponsor

Janssen Scientific Affairs, LLC

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.

Generelle publikationer

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. oktober 2013

Primær færdiggørelse (Faktiske)

1. april 2015

Studieafslutning (Faktiske)

1. april 2015

Datoer for studieregistrering

Først indsendt

6. september 2013

Først indsendt, der opfyldte QC-kriterier

6. september 2013

Først opslået (Skøn)

11. september 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. marts 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. marts 2017

Sidst verificeret

1. marts 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CR102208
  • 28431754DIA4002 (Anden identifikator: Janssen Scientific Affairs, 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 Forhøjet blodtryk

Kliniske forsøg med Canagliflozin

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Betingelser

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Placeringer

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