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CANVAS - CANagliflozin cardioVascular Assessment Study

NCT01032629 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4330

Last updated 2018-12-07

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Placebo

One placebo capsule taken orally (by mouth) once daily

DRUG

Canagliflozin (JNJ-28431754) 100 mg

One 100 mg capsule taken orally (by mouth) once daily

DRUG

Canagliflozin (JNJ-28431754) 300 mg

One 300 mg capsule taken orally (by mouth) once daily

Sponsors & Collaborators

  • The George Institute for Global Health, Australia

    collaborator OTHER

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-09
Primary Completion
2017-02-22
Completion
2017-02-22

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Canada
  • Colombia
  • Czechia
  • Estonia
  • France
  • Germany
  • Hungary
  • India
  • Israel
  • Luxembourg
  • Malaysia
  • Mexico
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • Russia
  • Spain
  • Sweden
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01032629 on ClinicalTrials.gov