An Integrated Assessment of the Safety and Effectiveness of Bexagliflozin for the Management of Essential Hypertension

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.

Timeline

Start

2017-10-18

Primary completion

2018-11-30

Completion

2018-11-30

Outcome

Met primary endpoint

registry analysis (superiority test); Bexagliflozin Tablets, 20 mg vs Placebo Tablets; p = 0.0025; LS Means difference -2.72 (95% CI -4.47 to -0.96); Covariance NCT03514641 ↗

registry analysis (superiority test); Bexagliflozin Tablets, 20 mg vs Placebo Tablets; p = 0.0117; Mean Difference (Final Values) -2.43 (95% CI -4.32 to -0.54); Covariance NCT03514641 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bexagliflozin	Small molecule	20 mg	—

Indications