Effects of Canagliflozin on Intravascular Volume and Hemodynamics

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT03190798
Phase
PHASE4
Status
Withdrawn

Conditions

  • Cardiovascular Diseases
  • Type2 Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Canagliflozin 300mg — DRUG
    Canagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. It works by decreasing the amount of sugar the body absorbs, and increasing the amount of sugar that leaves the body in the urine. Administered in 300mg tablets.
  • Placebo — DRUG
    Placebo for Canagliflozin

Study Details

RESEARCH HYPOTHESIS * In subjects with T2DM and HF, effect of canagliflozin will be superior to placebo for the change from baseline in PCWP after a single dose (6 hours post-dose) and after 4 weeks. * Treatment with canagliflozin will be well tolerated over 4 weeks.

Key Dates

Start date
Sep 1, 2017
Status verified
Jul 2017
Primary completion
Aug 1, 2018
Completion
Aug 1, 2018

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Canagliflozin Group
    Assuming a 25% dropout rate, 16 individuals in the canagliflozin group
  • Placebo Comparator: Placebo Group
    Assuming a 25% dropout rate, 11 individuals in the placebo group

Primary Outcome Measure

Change in Pulmonary capillary wedge pressure (PCWP) [ Time Frame: 6 hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at San AntonioSan AntonioTexas78229-

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By research site
The University of Texas Health Science Center at San Antonio· San Antonio, TX

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