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Essential HypertensionPhase 2/3NCT03514641

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

A Phase 2/3 study testing Bexagliflozin in people with Essential Hypertension, run by Theracos at 87 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Essential Hypertension
What is being tested?
Bexagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
673 participants
Where
87 sitesUnited States
Study dates
18 Oct 2017to 30 Nov 2018
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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 < 180 mm Hg
  • Unmedicated or prescribed no more than 4 agents for hypertension. Unmedicated subjects were subjects who had never taken medications for hypertension or had not taken any anti-hypertensive medication for at least 3 months. A stable dose meant no change in dose or frequency had taken place in the 4 weeks prior to the screening visit
  • If female and of childbearing potential, willing to use an adequate method of contraception and to not become pregnant for the duration of the study.
  • Willing and able to return for all clinic visits and to complete all study-required procedures
  • Able to self-medicate during the run-in period, omitting no more than one day of dosing
  • Shown to have a seated SBP ≥ 140 and < 180 mm Hg
  • Shown to exhibit a mean 24 h SBP ≥ 135 mm Hg

Prospective participants exhibiting any of the following characteristics were to be excluded from the study:

  • Diagnosis of type 1 diabetes mellitus or maturity-onset/diabetes of the young (MODY)
  • Known history of secondary or malignant hypertension
  • Seated diastolic blood pressure (DBP) >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 < 3 years
  • History of alcohol or illicit drug abuse in the past 2 years
  • History of myocardial infarction, stroke or hospitalization for heart failure in the prior 6 months
  • Previous exposure to bexagliflozin or EGT0001474
  • History of hypertensive emergency
  • History of sodium glucose linked transporter 2 (SGLT2) inhibitor treatment in the last 3 months
  • Known intolerance or allergy to SGTL2 inhibitors
  • Any condition, disease, disorder, or clinically relevant laboratory abnormality that, in the opinion of the PI, would jeopardize the subject's appropriate participation in this study or obscure the effects of treatment
  • Pregnancy or nursing
  • Current participation in another interventional trial or having been exposed to an investigational drug within 30 days or 7 half-lives of screening, whichever is longer
  • Arm circumference too large or small to allow accurate ambulatory monitoring
  • History of kidney transplant
  • Occupational or other lifestyle factors that could hamper the collection of valid ABPM data
  • 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
  • Estimated glomerular filtration rate (eGFR), as calculated by the modification of diet in renal disease study equation (MDRD), < 45 mL/min/1.73 m2 or requiring dialysis
  • HbA1c > 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), < 45 mL/min/1.73 m2 or requiring dialysis
  • HbA1c > 9.5%
  • Positive urine pregnancy test for female subjects of child bearing potential

Trial locations and contacts

87 sites in 1 country.

87 sites in 1 country

United States87 sites

  • Clinical Research Site

    Akron, Ohio, 44311

  • Clinical Research Site

    Albuquerque, New Mexico, 87102

  • Clinical Research Site

    Altoona, Pennsylvania, 16602

  • Clinical Research Site

    Anaheim, California, 92801

  • Clinical Research Site 2

    Anderson, South Carolina, 29621

  • Clinical Research Site

    Anderson, South Carolina, 29621

  • Clinical Research Site

    Arlington, Texas, 76014

  • Clinical Research Site

    Arlington, Virginia, 22207

  • Clinical Research Site

    Auburn, Maine, 04210

  • Clinical Research Site

    Avon, Indiana, 46123

  • Clinical Research Site

    Bellflower, California, 90706

  • Clinical Research Site

    Birmingham, Alabama, 35205

  • Clinical Research Site

    Birmingham, Alabama, 35211

  • Clinical Research Site

    Birmingham, Alabama, 35242

  • Clinical Research Site

    Bridgeton, Missouri, 63044

  • Clinical Research Site

    Brooklyn, New York, 11230

  • Clinical Research Site

    Burke, Virginia, 22015

  • Clinical Research Site

    Charlottesville, Virginia, 22911

  • Clinical Research Site

    Chicago, Illinois, 60602

  • Clinical Research Site

    Chicago, Illinois, 60611

  • Clinical Research Site

    Chicago, Illinois, 60616

  • Clinical Research Site

    Cincinnati, Ohio, 45236

  • Clinical Research Site

    Cincinnati, Ohio, 45245

  • Clinical Research Site

    Colorado Springs, Colorado, 80909

  • Clinical Research Site

    Colorado Springs, Colorado, 80918

  • Clinical Research Site

    Columbus, Ohio, 43213

  • Clinical Research Site

    Council Bluffs, Iowa, 51503

  • Clinical Research Site

    Dallas, Texas, 75231

  • Clinical Research Site

    Danville, Virginia, 24541

  • Clinical Research Site

    Dayton, Ohio, 45439

  • Clinical Research Site

    Decatur, Georgia, 30030

  • Clinical Research Site

    Decatur, Georgia, 30032

  • Clinical Research Site

    Denver, Colorado, 80246

  • Clinical Research Site

    Dublin, Ohio, 43215

  • Clinical Research Site

    Edina, Minnesota, 55435

  • Clinical Research Site

    Edmond, Oklahoma, 73034

  • Clinical Research Site

    Evansville, Indiana, 47714

  • Clinical Research Site

    Fair Oaks, California, 95628

  • Clinical Research Site

    Foley, Alabama, 36535

  • Clinical Research Site

    Fresno, California, 93702

  • Clinical Research Site

    Glendale, Arizona, 85306

  • Clinical Research Site

    Golden, Colorado, 80401

  • Clinical Research Site

    Greer, South Carolina, 29650

  • Clinical Research Site

    Grove City, Ohio, 43214

  • Clinical Research Site

    Gulf Shores, Alabama, 36542

  • Clinical Research Site

    Hartsdale, New York, 10530

  • Clinical Research Site

    Hatboro, Pennsylvania, 19040

  • Clinical Research Site

    Henderson, Nevada, 89074

  • Clinical Research Site

    Houston, Texas, 77070

  • Clinical Research Site

    Indianapolis, Indiana, 46260

  • Clinical Research Site

    Kingsport, Tennessee, 37660

  • Clinical Research Site

    Kingwood, Texas, 77339

  • Clinical Research Site

    Knoxville, Tennessee, 37909

  • Clinical Research Site

    Las Vegas, Nevada, 89128

  • Clinical Research Site

    Layton, Utah, 84041

  • Clinical Research Site

    Lexington, Kentucky, 40503

  • Clinical Research Site

    Lincoln, California, 95648

  • Clinical Research Site

    Lincoln, Rhode Island, 02865

  • Clinical Research Site

    Lithonia, Georgia, 30058

  • Clinical Research Site

    Los Angeles, California, 90057

  • Clinical Research Site

    Lyndhurst, Ohio, 44124

  • Clinical Research Site

    Manassas, Virginia, 20110

  • Clinical Research Site

    Mesa, Arizona, 85206

  • Clinical Research Site

    Mesquite, Texas, 75143

  • Clinical Research Site

    Murray, Utah, 84123

  • Clinical Research Site

    New Orleans, Louisiana, 70115

  • Clinical Research Site

    Oklahoma City, Oklahoma, 73119

  • Clinical Research Site

    Paducah, Kentucky, 42003

  • Clinical Research Site

    Phoenix, Arizona, 85020

  • Clinical Research Site

    Plano, Texas, 75093

  • Clinical Research Site

    Portland, Oregon, 97239

  • Clinical Research Site

    Prairie Village, Kansas, 66208

  • Clinical Research Site

    San Antonio, Texas, 78229

  • Clinical Research Site

    San Gabriel, California, 91776

  • Clinical Research Site

    Santa Rosa, California, 95405

  • Clinical Research Site

    Shelby, North Carolina, 28150

  • Clinical Research Site

    Silver Spring, Maryland, 20910

  • Clinical Research Site

    St Louis, Missouri, 63141

  • Clinical Research Site

    Stamford, Connecticut, 06905

  • Clinical Research Site

    Tacoma, Washington, 98405

  • Clinical Research Site

    The Bronx, New York, 10455

  • Clinical Research Site

    Tomball, Texas, 77375

  • Clinical Research Site

    Trenton, New Jersey, 08611

  • Clinical Research Site

    Tucson, Arizona, 85741

  • Clinical Research Site

    Upland, California, 91786

  • Clinical Research Site

    Versailles, Kentucky, 40383

  • Clinical Research Site

    West Jordan, Utah, 84088

Other trials in United States

About this study

Official title: An Integrated Assessment of the Safety and Effectiveness of Bexagliflozin Tablets, 20 mg, for the Management of Essential Hypertension

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.

Read the 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.

Being tested
Bexagliflozin, Placebo
Medical subject headings
Essential Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BexagliflozinDrug

    Also called EGT0001442

    Bexagliflozin tablet, 20 mg

  • PlaceboDrug

    Placebo (inactive) tablet to match the active drug

Study groups in NCT03514641
Study groupRoleWhat they receive
Sequence 1OtherPeriod 1: Placebo Period 2: Bexagliflozin Period 3: Bexagliflozin
Receives: Drug: Bexagliflozin; Drug: Placebo
Sequence 2OtherPeriod 1: Placebo Period 2: Bexagliflozin Period 3: Placebo
Receives: Drug: Bexagliflozin; Drug: Placebo
Sequence 3OtherPeriod 1: Bexagliflozin Period 2: Bexagliflozin Period 3: Bexagliflozin
Receives: Drug: Bexagliflozin
Sequence 4OtherPeriod 1: Bexagliflozin Period 2: Bexagliflozin Period 3: Placebo
Receives: Drug: Bexagliflozin; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline (Day 1) to week 12

  2. 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

    Measured: Change from week 24 to week 36

Secondary outcomes (12)

  1. 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

    Measured: Baseline (Day 1) to week 12

  2. 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

    Measured: Baseline (Day 1) to week 12

  3. 603A, Change in Seated Office Systolic Blood Pressure

    Placebo-adjusted change in seated office systolic blood pressure

    Measured: Baseline (Day 1) to week 12

  4. 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

    Measured: Baseline (Day 1) to week 12

  5. 603A, Change in Mean Ambulatory Diastolic Blood Pressure

    Placebo-adjusted change in mean ambulatory diastolic blood pressure

    Measured: Baseline (Day 1) to week 12

  6. 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

    Measured: Baseline (Day 1) to week 12

  7. 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

    Measured: Baseline (Day 1) to week 12

  8. 603A, Change in Seated Office Diastolic Blood Pressure

    Placebo-adjusted change in seated office diastolic blood pressure

    Measured: Baseline (Day 1) to week 12

  9. 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

    Measured: Baseline (Day 1) to week 12

  10. 603B, Change in Seated Office Systolic Blood Pressure

    Placebo-adjusted change from week 12 to week 24 in seated office systolic blood pressure

    Measured: Week 12 (cumulative week 24) to Week 24 (cumulative week 36)

  11. 603B, Change in Mean Ambulatory Diastolic Blood Pressure

    Placebo-adjusted change in mean ambulatory diastolic blood pressure

    Measured: Week 12 (cumulative week 24) to Week 24 (cumulative week 36)

  12. 603B, Change in Seated Office Diastolic Blood Pressure

    Placebo-adjusted change from week 12 to week 24 in seated office diastolic blood pressure

    Measured: Week 12 (cumulative week 24) to Week 24 (cumulative week 36)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2018
  2. Study start18 Oct 2017
  3. Primary completion30 Nov 2018
  4. Study completion30 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The primary endpoint of study 603A is the change from baseline (Day 1) to week 12 in the 24-hour average SBP of the bexagliflozin group compared to the placebo group using a superiority testing at an overall two-sided 0.05 level of significance. The primary endpoint of study 603B is the change from week 12 (cumulative week 24) to week 24 (cumulative week 36) in the 24-hour average SBP in the bexagliflozin group compared to the placebo group using a superiority testing at an overall two-sided 0.05 level of significance.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
673 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03514641
Sponsor's protocol ID
THR-1442-C-603
Status last verified
Aug 2021
First submitted
8 Nov 2017
Last updated
21 Sep 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Bexagliflozin in people with Essential Hypertension, run by Theracos at 87 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of the 24 Hour Mean Systolic Blood Pressure From Baseline (Day 1) to Week 12 (time frame: Baseline (Day 1) to week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03514641.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.

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