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

NCT03514641 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 673

Last updated 2021-09-21

Study results available
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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.

Conditions

  • Essential Hypertension

Interventions

DRUG

Bexagliflozin

Bexagliflozin tablet, 20 mg

DRUG

Placebo

Placebo (inactive) tablet to match the active drug

Sponsors & Collaborators

  • Theracos

    lead INDUSTRY

Principal Investigators

  • Andrew Allegretti, M.D. · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-18
Primary Completion
2018-11-30
Completion
2018-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03514641 on ClinicalTrials.gov