Efficacy and Safety of Azilsartan Medoxomil Used in Combination With Metformin in Participants With Hypertension and Diabetes

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Hypertension, Diabetes

In brief

The purpose of this study was to evaluate the antihypertensive and antiglycemic effects, as well as the safety and tolerability of TAK-491 (azilsartan medoxomil), once daily (QD), in stage 1 hypertensive, type 2 diabetes mellitus (T2DM) participants whose glycemic control was inadequate on metformin alone.

Key facts

Study ID

NCT01496430

Run by

Takeda

People needed

105

Starts

2012-01-01

Expected to finish

2013-05-01

Last updated by the study team

2015-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Was male or female and ≥18 years.
• Had type 2 diabetes mellitus with HbA1c of ≥7.5 to ≤9.5% at Screening.
• Was treated with metformin alone (no treatment with any antidiabetic agents other than metformin within the 3 months prior to Screening) and was experiencing inadequate glycemic control. The participant should have received metformin monotherapy for ≥8 weeks prior to Screening at a stable dose ≥1500 mg). Participants with a maximum tolerated dose (MTD) that was documented to be less than 1500 mg of metformin could also be enrolled if this dose had been stable for 8 weeks prior to Screening.
• Was treated with antihypertensive therapy and had a mean, trough, sitting clinic systolic blood pressure (SBP) ≥135 and < 160 mm Hg on Day -1 (after washout of prior antihypertensive therapy) or the participant had not received antihypertensive treatment within 28 days before Screening and had a mean sitting clinic SBP ≥135 and < 160 mm Hg at the Screening Visit and on Day -1.
• Had clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory or results that were deemed not clinically significant in this participant population for inclusion in this study, by the investigator.

You may not qualify if…

• Had a mean, trough, sitting clinic diastolic blood pressure (DBP) ≥ 100 mm Hg at Day -1.
• Had type 1 or poorly controlled type 2 diabetes mellitus (HbA1c >9.5%) at Screening.
• Was taking or expected to take an excluded medication.
• Had a history of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
• Had clinically significant cardiac conduction defects (for example, 3rd degree atrioventricular block, left bundle branch block, sick sinus syndrome, atrial fibrillation).
• Had hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.
• Had secondary hypertension of any etiology (e.g., renovascular disease, pheochromocytoma, Cushing's syndrome).
• Had renal dysfunction defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 at Screening.
• Had albuminuria defined as >200 mg/g at Screening.
• Had known or suspected unilateral or bilateral renal artery stenosis.
• Had unexplained microhematuria ≥3 RBCs/HPF or macrohematuria at Screening and confirmed on repeat testing.
• Treatment with antidiabetic agents (sulfonylureas, glucagon-like peptide-1 (GLP-1) analogues, dipeptidyl peptidase-4 (DPP-4) inhibitors, glinides, thiazolidinediones (TZDs), and/or insulin) other than metformin during the 3 months prior to Screening.
• Had hyperkalemia as defined by central laboratory normal reference range at Screening.

Where it is running

• Study site — Green Valley, Arizona, United States
• Study site — Tempe, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Buena Park, California, United States
• Study site — Hawaiian Gardens, California, United States
• Study site — Norwalk, California, United States
• Study site — Paramount, California, United States
• Study site — Rancho Cucamonga, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — Tustin, California, United States
• Study site — Denver, Colorado, United States
• Study site — Bradenton, Florida, United States
• Study site — Brooksville, Florida, United States
• Study site — Hallandale, Florida, United States
• Study site — Jupiter, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Roswell, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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