An Integrated Assessment of the Safety and Effectiveness of Bexagliflozin for the Management of Essential Hypertension
- Registration Number
- NCT03514641
- Lead Sponsor
- Theracos
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 673
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sequence 2 Placebo Period 1: Placebo Period 2: Bexagliflozin Period 3: Placebo Sequence 4 Placebo Period 1: Bexagliflozin Period 2: Bexagliflozin Period 3: Placebo Sequence 1 Placebo Period 1: Placebo Period 2: Bexagliflozin Period 3: Bexagliflozin Sequence 1 Bexagliflozin Period 1: Placebo Period 2: Bexagliflozin Period 3: Bexagliflozin Sequence 2 Bexagliflozin Period 1: Placebo Period 2: Bexagliflozin Period 3: Placebo Sequence 3 Bexagliflozin Period 1: Bexagliflozin Period 2: Bexagliflozin Period 3: Bexagliflozin Sequence 4 Bexagliflozin Period 1: Bexagliflozin Period 2: Bexagliflozin Period 3: Placebo
- Primary Outcome Measures
Name Time Method Change of the 24 Hour Mean Systolic Blood Pressure From Baseline (Day 1) to Week 12 Baseline (Day 1) to week 12 Change of the 24 hour mean systolic blood pressure in the bexagliflozin group compared to placebo
Change of the 24 Hour Mean Systolic Blood Pressure From Cumulative Week 24 to Week 36 Change from week 24 to week 36 Change of the 24 hour mean systolic blood pressure in the bexagliflozin group compared placebo
- Secondary Outcome Measures
Name Time Method 603A, Change in Seated Office Systolic Blood Pressure Baseline (Day 1) to week 12 Placebo-adjusted change in seated office systolic blood pressure
603A, Seated Office Systolic Blood Pressure of 140 mm Hg or Less Baseline (Day 1) to week 12 Proportion of subjects who achieve a seated office systolic blood pressure of 140 mm Hg or less
603A, Seated Office Diastolic Blood Pressure of 90 mm Hg or Less Baseline (Day 1) to week 12 Proportion of subjects who achieve a mean seated office diastolic blood pressure of 90 mm Hg or less
603A, Change in Mean Ambulatory Diastolic Blood Pressure Baseline (Day 1) to week 12 Placebo-adjusted change in mean ambulatory diastolic blood pressure
603B, Change in Seated Office Systolic Blood Pressure Week 12 (cumulative week 24) to Week 24 (cumulative week 36) Placebo-adjusted change from week 12 to week 24 in seated office systolic blood pressure
603B, Change in Seated Office Diastolic Blood Pressure Week 12 (cumulative week 24) to Week 24 (cumulative week 36) Placebo-adjusted change from week 12 to week 24 in seated office diastolic blood pressure
603A, Reduction of Mean Ambulatory Systolic Blood Pressure Baseline (Day 1) to week 12 Proportion of subjects who achieve a reduction of mean ambulatory systolic blood pressure of 10 mm Hg or greater
603A, Mean Ambulatory Diastolic Blood Pressure of 87 mm Hg or Less Baseline (Day 1) to week 12 Proportion of subjects who achieve a mean ambulatory diastolic blood pressure of 87 mm Hg or less
603A, Mean Ambulatory Systolic Blood Pressure of 135 mm Hg or Less Baseline (Day 1) to week 12 Proportion of subjects who achieve a mean ambulatory systolic blood pressure of 135 mm Hg or less
603A, Change in Seated Office Diastolic Blood Pressure Baseline (Day 1) to week 12 Placebo-adjusted change in seated office diastolic blood pressure
603B, Change in Mean Ambulatory Diastolic Blood Pressure Week 12 (cumulative week 24) to Week 24 (cumulative week 36) Placebo-adjusted change in mean ambulatory diastolic blood pressure
603A, Reduction of Mean Ambulatory Diastolic Blood Pressure of 4 mm Hg or Greater Baseline (Day 1) to week 12 Proportion of subjects who achieve a reduction of mean ambulatory diastolic blood pressure of 4 mm Hg or greater
Trial Locations
- Locations (2)
Clinical Research Site
🇺🇸Tacoma, Washington, United States
Clinical Research Site 2
🇺🇸Anderson, South Carolina, United States