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

Completed · Phase 4 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2, Hypertension

In brief

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 facts

Study ID

NCT01939496

Run by

Janssen Scientific Affairs, LLC

People needed

171

Starts

2013-10-01

Expected to finish

2015-04-01

Last updated by the study team

2017-03-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• patients with a diagnosis of type 2 diabetes mellitus
• patients with hypertension (seated office SBP of >=130 mmHg and <160 mmHg and seated office DBP of >= 70 mmHg at screening and at Week -2
• patients on stable doses of 1 to 3 anti-hypertensive agents for at least 5 weeks before screening
• patients on stable doses of 1 to 3 oral anti-hyperglycemic agents which must include metformin, for at least 8 weeks before screening

You may not qualify if…

• a history of diabetic ketoacidosis
• type 1 diabetes mellitus (T1DM)
• pancreas or beta-cell transplantation
• fasting C-peptide <0.70 ng/mL (0.23 nmol/L)
• body mass index <30 kg/m2
• has ongoing, inadequately controlled thyroid disorder
• has a history of cardio-renal disease that required treatment with immunosuppressive therapy.

Where it is running

• Study site — Gulf Shores, Alabama, United States
• Study site — Avondale, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Glendale, California, United States
• Study site — Los Angeles, California, United States
• Study site — Newport Beach, California, United States
• Study site — Pismo Beach, California, United States
• Study site — Rancho Cucamonga, California, United States
• Study site — Roseville, California, United States
• Study site — Sacramento, California, United States
• Study site — Spring Valley, California, United States
• Study site — Tustin, California, United States
• Study site — Denver, Colorado, United States
• Study site — Brandon, Florida, United States
• Study site — Doral, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Lake Worth, Florida, United States
• Study site — Lauderdale Lakes, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami Lakes, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Port Orange, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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