A Study of the Safety and Effectiveness of Canagliflozin (JNJ-28431754) in Promoting Weight Loss in Overweight and Obese Patients Who do Not Have Diabetes

Part of paid clinical trials in Hot Springs, Arkansas.

Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study ID
NCT00650806
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Canagliflozin (JNJ-28431754) — DRUG
    One 50 mg, 100 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks.
  • Placebo — DRUG
    One matching placebo capsule orally once daily for 12 weeks.

Study Details

The purpose of this study is to test the safety and effectiveness of JNJ-28431754 in promoting weight loss in patients who are overweight or obese and who do not have diabetes.

Key Dates

Start date
May 31, 2008
Status verified
Apr 2013
Primary completion
Sep 30, 2008
Completion
Sep 30, 2008

Study Design

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

Arms

  • Experimental: Canagliflozin 50 mg
    Each patient will receive 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
  • Experimental: Canagliflozin 100 mg
    Each patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
  • Experimental: Canagliflozin 300 mg
    Each patient will receive 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
  • Placebo Comparator: Placebo
    Each patient will receive matching placebo once daily for 12 weeks.

Primary Outcome Measure

Percent Change in Body Weight From Baseline to Week 12 [ Time Frame: Day 1 (Baseline) and Week 12 ]

Locations (35)

FacilityCityStateZIPSite coordinators
-Hot SpringsArkansas--
-Walnut CreekCalifornia--
-Westlake VillageCalifornia--
-DestinFlorida--
-JacksonvilleFlorida--
-AugustaGeorgia--
-DecaturGeorgia--
-StockbridgeGeorgia--
-BoiseIdaho--
-EagleIdaho--
-MeridianIdaho--
-EvansvilleIndiana--
-Overland ParkKansas--
-WitchitaKansas--
-LexingtonKentucky--
-LouisvilleKentucky--
-New OrleansLouisiana--
-AuburnMaine--
-MilfordMassachusetts--
-JacksonMississippi--
-OmahaNebraska--
-ManilusNew York--
-MedfordOregon--
-PortlandOregon--
-Goose CreekSouth Carolina--
-Mt. PleasantSouth Carolina--
-KnoxvilleTennessee--
-NashvilleTennessee--
-AmarilloTexas--
-DallasTexas--
-OdessaTexas--
-San AntonioTexas--
-West JordanUtah--
-NorfolkVirginia--
-WauwatosaWisconsin--

Find similar trials in Hot Springs, AR

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss

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