Phase 3
Completed N=673
An Integrated Assessment of the Safety and Effectiveness of Bexagliflozin for the Management of Essential Hypertension
Source: ClinicalTrials.gov NCT03514641 ↗Enrolled (actual)
673
Serious AEs
2.9%
Results posted
Sep 2021
Primary outcomePrimary: Change of the 24 Hour Mean Systolic Blood Pressure From Baseline (Day 1) to Week 12 — -8.86; -6.15 mm Hg — p=0.0025
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of the 24 Hour Mean Systolic Blood Pressure From Baseline (Day 1) to Week 12 |
-8.86; -6.15 | 0.0025 sig |
| PRIMARY Change of the 24 Hour Mean Systolic Blood Pressure From Cumulative Week 24 to Week 36 |
0.30; 2.74 | 0.0117 sig |
| SECONDARY 603A, Reduction of Mean Ambulatory Systolic Blood Pressure |
0.40; 0.34 | 0.1317 |
| SECONDARY 603A, Mean Ambulatory Systolic Blood Pressure of 135 mm Hg or Less |
0.40; 0.29 | 0.0113 sig |
| SECONDARY 603A, Change in Seated Office Systolic Blood Pressure |
-11.24; -6.61 | <0.0001 sig |
| SECONDARY 603A, Seated Office Systolic Blood Pressure of 140 mm Hg or Less |
0.38; 0.25 | 0.0004 sig |
| SECONDARY 603A, Change in Mean Ambulatory Diastolic Blood Pressure |
-3.92; -3.08 | 0.0863 |
| SECONDARY 603A, Mean Ambulatory Diastolic Blood Pressure of 87 mm Hg or Less |
0.47; 0.37 | 0.0232 sig |
| SECONDARY 603A, Reduction of Mean Ambulatory Diastolic Blood Pressure of 4 mm Hg or Greater |
0.88; 0.80 | 0.0140 sig |
| SECONDARY 603A, Change in Seated Office Diastolic Blood Pressure |
-4.44; -2.13 | 0.0011 sig |
| SECONDARY 603A, Seated Office Diastolic Blood Pressure of 90 mm Hg or Less |
0.65; 0.53 | 0.0094 sig |
| SECONDARY 603B, Change in Seated Office Systolic Blood Pressure |
1.98; 5.18 | 0.0083 sig |
| SECONDARY 603B, Change in Mean Ambulatory Diastolic Blood Pressure |
0.10; 0.94 | 0.1085 |
| SECONDARY 603B, Change in Seated Office Diastolic Blood Pressure |
0.51; 1.76 | 0.0837 |
Eligibility Criteria
To be eligible for randomization a prospective subject was to be:
- Male or female of age ≥ 20 years
- Diagnosed with essential hypertension and exhibiting an office seated SBP ≥ 140 and 110 mm Hg at screening
- Taking insulin for diabetes
- Prescribed more than 4 anti-hypertension medications
- Having a genitourinary tract infection within 6 weeks of screening or history of ≥ 3 genitourinary infections requiring treatment within the last 6 months
- Having cancer, active or in remission for 1.5 × upper limit of normal (ULN) with the exception of isolated Gilbert's syndrome); or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × ULN
- Estimated glomerular filtration rate (eGFR), as calculated by the modification of diet in renal disease study equation (MDRD), 9.5%
- Positive urine pregnancy test for female subjects of child bearing potential
- Evidence of abnormal liver function tests (total bilirubin or alkaline phosphatase > 1.5 × upper limit of normal (ULN) with the exception of isolated Gilbert's syndrome); or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × ULN
- eGFR, as calculated by the modification of diet in renal disease study equation (MDRD), 9.5%
- Positive urine pregnancy test for female subjects of child bearing potential
Data sourced from ClinicalTrials.gov (NCT03514641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.