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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Janssen Scientific Affairs, LLC
Study ID
NCT01939496
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 31, 2013
Status verified
Mar 2017
Primary completion
Apr 30, 2015
Completion
Apr 30, 2015

Study Design

Enrollment
171 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Canagliflozin 100 mg
    Each patient will receive 100 mg of canagliflozin once daily for 6 weeks.
  • Experimental: Canagliflozin 300 mg
    Each patient will receive 300 mg of canagliflozin once daily for 6 weeks.
  • Placebo Comparator: Placebo
    Each patient will receive matching placebo once daily for 6 weeks.

Primary Outcome Measure

Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to Week 6 [ Time Frame: Baseline and Week 6 ]

Locations (54)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama--
-Gulf ShoresAlabama--
-AvondaleArizona--
-PhoenixArizona--
-GlendaleCalifornia--
-Los AngelesCalifornia--
-Newport BeachCalifornia--
-Pismo BeachCalifornia--
-Rancho CucamongaCalifornia--
-RosevilleCalifornia--
-SacramentoCalifornia--
-Spring ValleyCalifornia--
-TustinCalifornia--
-DenverColorado--
-BrandonFlorida--
-DoralFlorida--
-Fort LauderdaleFlorida--
-Lake WorthFlorida--
-Lauderdale LakesFlorida--
-MiamiFlorida--
-Miami LakesFlorida--
-OrlandoFlorida--
-Pembroke PinesFlorida--
-Port OrangeFlorida--
-West Palm BeachFlorida--
-PerryGeorgia--
-RinconGeorgia--
-IndianapolisIndiana--
-TopekaKansas--
-LexingtonKentucky--
-MandevilleLouisiana--
-MarreroLouisiana--
-MetairieLouisiana--
-AuburnMaine--
-ElkridgeMaryland--
-DearbornMichigan--
-KalamazooMichigan--
-JacksonMississippi--
-St LouisMissouri--
-MorganvilleNew Jersey--
-WhitingNew Jersey--
-AlbuquerqueNew Mexico--
-RaleighNorth Carolina--
-Oklahoma CityOklahoma--
-AltoonaPennsylvania--
-JenkintownPennsylvania--
-NashvilleTennessee--
-AustinTexas--
-DallasTexas--
-HoustonTexas--
-PlanoTexas--
-Sugar LandTexas--
-Salt Lake CityUtah--
-RentonWashington--

Find similar trials in Birmingham, AL

By condition
Type 2 diabetesHypertension (high blood pressure)
By specialty
EndocrinologyMetabolic healthWeight lossCardiologyHeart disease

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