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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 marzo 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

171

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Canagliflozin 100 mg
Each patient will receive 100 mg of canagliflozin once daily for 6 weeks.
Droga: 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.
Sperimentale: Canagliflozin 300 mg
Each patient will receive 300 mg of canagliflozin once daily for 6 weeks.
Droga: 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.
Comparatore placebo: Placebo
Each patient will receive matching placebo once daily for 6 weeks.
Droga: Placebo
One matching placebo capsule orally in addition to the patient's anti-hyperglycemic agents (AHA) regimen used in accordance with local prescribing information.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to Week 6
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Mean 24-Hour Systolic Blood Pressure (SBP) to Day 2
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline and Week 6
The fasting plasma glucose was evaluated.
Baseline and Week 6
Change From Baseline in Body Weight to Week 6
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Janssen Scientific Affairs, LLC

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2013

Completamento primario (Effettivo)

1 aprile 2015

Completamento dello studio (Effettivo)

1 aprile 2015

Date di iscrizione allo studio

Primo inviato

6 settembre 2013

Primo inviato che soddisfa i criteri di controllo qualità

6 settembre 2013

Primo Inserito (Stima)

11 settembre 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 marzo 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 marzo 2017

Ultimo verificato

1 marzo 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CR102208
  • 28431754DIA4002 (Altro identificatore: Janssen Scientific Affairs, LLC)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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