CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 171 enrolled
Drug / intervention
Canagliflozin +1 moredrug
Likely dose
Canagliflozin 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01939496
NCT01939496Phase 4Completed
CompareCT.gov

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

Janssen Scientific Affairs, LLC·interventional·Posted Sep 11, 2013·Updated Mar 3, 2017

In Brief

A Phase 4 clinical trial evaluating Canagliflozin and Placebo for Diabetes Mellitus, Type 2 and Hypertension. Completed, enrolled 171 participants across 57 sites in 2 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2, Hypertension
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 11, 2013
Enrollment StartOct 1, 2013
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 12.8 years ago

Interventions

Canagliflozindrug

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.

Placebodrug

One matching placebo capsule orally in addition to the patient's anti-hyperglycemic agents (AHA) regimen used in accordance with local prescribing information.