This integrated assessment consists of two studies, 603A and 603B, to be carried out sequentially in a common study population. Participating subjects informed of the trial design and their consent to participate in both studies were to be obtained in a single consent form. Approximately 680 male or female adult subjects were to be enrolled.
THR-1442-C-603 is an integrated assessment of the potential utility of bexagliflozin tablets, 20 mg for the treatment of essential hypertension. It is composed of two studies, 603A and 603B, measuring effects in a common population. 603A was a multicenter double-blind parallel group placebo-controlled study conducted to determine the placebo-adjusted change from baseline to week 12 in the mean ambulatory systolic blood pressure (SBP) of approximately 680 subjects considered generally representative of the adult hypertensive population in the United States. Secondary endpoints included the placebo-adjusted change from baseline to week 12 of the mean office seated systolic blood pressure, the change to week 12 of the mean ambulatory and mean office seated diastolic blood pressure, the proportion of subjects achieving prespecified goals for absolute systolic and diastolic blood pressure as well as prespecified goals for reduction in systolic and diastolic blood pressure, measured by ambulatory and seated office measurement methodology. A603B was a multicenter double-blind parallel group placebo-controlled randomized withdrawal study conducted to determine the durability of the antihypertensive effect of bexagliflozin tablets, 20 mg, in a population not pre-selected for existing diabetes. All subjects entered a 12 week run-in period during which they self-administered open label bexagliflozin tablets, 20 mg once daily. At week 12 a baseline ambulatory blood pressure monitoring (ABPM) measurement was made, and the subjects were randomized one to one to receive either bexagliflozin tablets, 20 mg or bexagliflozin tablets, placebo. After a 12 week treatment period a second ABPM measurement was made. The primary endpoint was the intergroup difference in the change from baseline in the mean SBP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
673
Bexagliflozin tablet, 20 mg
Placebo (inactive) tablet to match the active drug
Change of the 24 Hour Mean Systolic Blood Pressure From Baseline (Day 1) to Week 12
Change of the 24 hour mean systolic blood pressure in the bexagliflozin group compared to placebo
Time frame: Baseline (Day 1) to week 12
Change of the 24 Hour Mean Systolic Blood Pressure From Cumulative Week 24 to Week 36
Change of the 24 hour mean systolic blood pressure in the bexagliflozin group compared placebo
Time frame: Change from week 24 to week 36
603A, Reduction of Mean Ambulatory Systolic Blood Pressure
Proportion of subjects who achieve a reduction of mean ambulatory systolic blood pressure of 10 mm Hg or greater
Time frame: Baseline (Day 1) to week 12
603A, Mean Ambulatory Systolic Blood Pressure of 135 mm Hg or Less
Proportion of subjects who achieve a mean ambulatory systolic blood pressure of 135 mm Hg or less
Time frame: Baseline (Day 1) to week 12
603A, Change in Seated Office Systolic Blood Pressure
Placebo-adjusted change in seated office systolic blood pressure
Time frame: Baseline (Day 1) to week 12
603A, Seated Office Systolic Blood Pressure of 140 mm Hg or Less
Proportion of subjects who achieve a seated office systolic blood pressure of 140 mm Hg or less
Time frame: Baseline (Day 1) to week 12
603A, Change in Mean Ambulatory Diastolic Blood Pressure
Placebo-adjusted change in mean ambulatory diastolic blood pressure
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Time frame: Baseline (Day 1) to week 12
603A, Mean Ambulatory Diastolic Blood Pressure of 87 mm Hg or Less
Proportion of subjects who achieve a mean ambulatory diastolic blood pressure of 87 mm Hg or less
Time frame: Baseline (Day 1) to week 12
603A, Reduction of Mean Ambulatory Diastolic Blood Pressure of 4 mm Hg or Greater
Proportion of subjects who achieve a reduction of mean ambulatory diastolic blood pressure of 4 mm Hg or greater
Time frame: Baseline (Day 1) to week 12
603A, Change in Seated Office Diastolic Blood Pressure
Placebo-adjusted change in seated office diastolic blood pressure
Time frame: Baseline (Day 1) to week 12
603A, Seated Office Diastolic Blood Pressure of 90 mm Hg or Less
Proportion of subjects who achieve a mean seated office diastolic blood pressure of 90 mm Hg or less
Time frame: Baseline (Day 1) to week 12
603B, Change in Seated Office Systolic Blood Pressure
Placebo-adjusted change from week 12 to week 24 in seated office systolic blood pressure
Time frame: Week 12 (cumulative week 24) to Week 24 (cumulative week 36)
603B, Change in Mean Ambulatory Diastolic Blood Pressure
Placebo-adjusted change in mean ambulatory diastolic blood pressure
Time frame: Week 12 (cumulative week 24) to Week 24 (cumulative week 36)
603B, Change in Seated Office Diastolic Blood Pressure
Placebo-adjusted change from week 12 to week 24 in seated office diastolic blood pressure
Time frame: Week 12 (cumulative week 24) to Week 24 (cumulative week 36)