CANVAS - CANagliflozin cardioVascular Assessment Study

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT01032629
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The study will assess canagliflozin (JNJ-28431754) in the treatment of patients with type 2 diabetes mellitus (T2DM) with regard to cardiovascular (CV) risk for major adverse cardiac events (MACE). Other objectives include evaluating the overall safety, tolerability, and effectiveness of canagliflozin. The data from this study will be combined with the data from CANVAS-R study (Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects with T2DM, NCT01989754) in a pre-specified integrated analysis of CV safety outcomes to satisfy US FDA post-marketing requirements for canagliflozin.

Key Dates

Start date
Dec 9, 2009
Status verified
Nov 2018
Primary completion
Feb 22, 2017
Completion
Feb 22, 2017

Study Design

Enrollment
4,330 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Each patient will receive placebo (inactive medication) on background standard of care for diabetes once daily for the duration of the study
  • Experimental: Canagliflozin (JNJ-28431754) 100 mg
    Each patient will receive canagliflozin (JNJ-28431754) 100 mg once daily on background standard of care for diabetes once daily for the duration of the study
  • Experimental: Canagliflozin (JNJ-28431754) 300 mg
    Each patient will receive canagliflozin (JNJ-28431754) 300 mg once daily on background standard of care for diabetes once daily for the duration of the study

Primary Outcome Measure

Major Adverse Cardiovascular Events (MACE) Composite of Cardiovascular (CV) Death, Non-Fatal Myocardial Infarction (MI), and Non-Fatal Stroke [ Time Frame: Up to approximately 8 years ]

Locations (58)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama--
-MesaArizona--
-TucsonArizona--
-La MesaCalifornia--
-Los GatosCalifornia--
-Pismo BeachCalifornia--
-StocktonCalifornia--
-Walnut CreekCalifornia--
-DoralFlorida--
-Fort LauderdaleFlorida--
-JacksonvilleFlorida--
-MiamiFlorida--
-PlantationFlorida--
-AtlantaGeorgia--
-DuluthGeorgia--
-BoiseIdaho--
-EagleIdaho--
-MeridianIdaho--
-PeoriaIllinois--
-TopekaKansas--
-Crestview HillsKentucky--
-LexingtonKentucky--
-AuburnMaine--
-ScarboroughMaine--
-Oxon HillMaryland--
-Royal OakMichigan--
-Kansas CityMissouri--
-St LouisMissouri--
-OmahaNebraska--
-CamdenNew Jersey--
-FlushingNew York--
-The BronxNew York--
-Chapel HillNorth Carolina--
-CharlotteNorth Carolina--
-CincinnatiOhio--
-ClevelandOhio--
-ColumbusOhio--
-GallipolisOhio--
-MentorOhio--
-ToledoOhio--
-BeaverPennsylvania--
-NorristownPennsylvania--
-SayrePennsylvania--
-GreenvilleSouth Carolina--
-KingsportTennessee--
-DallasTexas--
-HoustonTexas--
-OdessaTexas--
-San AntonioTexas--
-TempleTexas--
-DraperUtah--
-Salt Lake CityUtah--
-Sandy CityUtah--
-West JordanUtah--
-DanvilleVirginia--
-RichmondVirginia--
-SpokaneWashington--
-TacomaWashington--

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