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

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ClinicalTrials.gov Identifier: NCT03514641
Recruitment Status : Completed
First Posted : May 2, 2018
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
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 will be informed of the trial design and their consent to participate in both studies will be obtained in a single consent form. Approximately 680 male or female adult subjects will be enrolled.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: Bexagliflozin Drug: Placebo Phase 2 Phase 3

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.

Approximately 680 male or female adult subjects who exhibit an office seated blood pressure ≥140 mm Hg and <180 mm Hg, and who are taking no more than 4 anti-hypertension medications will be enrolled in study 603A.

Upon returning to the investigational site to surrender the ambulatory monitor at the conclusion of study 603A, subjects will begin participation in study 603B. They will receive a 12-week supply of bexagliflozin tablets, 20 mg. At week 12 (cumulative week 24) subjects will visit the investigational site to consume the bexagliflozin tablet and to be fitted with an ambulatory monitor to record their baseline mean blood pressure. The following day, subjects will be randomized 1:1 to receive a 12-week supply of bexagliflozin tablets, 20 mg or bexagliflozin tablets, placebo. Assignment to the active or placebo arm will be balanced.

An assessment of bexagliflozin population pharmacokinetics (PK) will also be conducted, to include approximately 200 subjects.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 678 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
  • Study 603A: bexagliflozin tablets, 20 mg or placebo
  • Study 603B week 1 to week 12: bexagliflozin tablets, 20 mg
  • Study 603B week 13 to week 24: bexagliflozin tablets, 20 mg or placebo
Primary Purpose: Treatment
Official Title: An Integrated Assessment of the Safety and Effectiveness of Bexagliflozin Tablets, 20 mg, for the Management of Essential Hypertension
Actual Study Start Date : October 18, 2017
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sequence 1
Period 1: Placebo Period 2: Bexagliflozin Period 3: Bexagliflozin
Drug: Bexagliflozin
Bexagliflozin tablet, 20 mg
Other Name: EGT0001442

Drug: Placebo
Placebo (inactive) tablet to match the active drug

Sequence 2
Period 1: Placebo Period 2: Bexagliflozin Period 3: Placebo
Drug: Bexagliflozin
Bexagliflozin tablet, 20 mg
Other Name: EGT0001442

Drug: Placebo
Placebo (inactive) tablet to match the active drug

Sequence 3
Period 1: Bexagliflozin Period 2: Bexagliflozin Period 3: Bexagliflozin
Drug: Bexagliflozin
Bexagliflozin tablet, 20 mg
Other Name: EGT0001442

Sequence 4
Period 1: Bexagliflozin Period 2: Bexagliflozin Period 3: Placebo
Drug: Bexagliflozin
Bexagliflozin tablet, 20 mg
Other Name: EGT0001442

Drug: Placebo
Placebo (inactive) tablet to match the active drug




Primary Outcome Measures :
  1. Change of the 24 hour mean systolic blood pressure from Baseline (Day 1) to week 12 [ Time Frame: Baseline (Day 1) to week 12 ]
    Change of the 24 hour mean systolic blood pressure in the bexagliflozin group compared to placebo

  2. Change of the 24 hour mean systolic blood pressure from cumulative week 24 to week 36 [ Time Frame: 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 :
  1. 603A, reduction of mean ambulatory systolic blood pressure [ Time Frame: 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

  2. 603A, mean ambulatory systolic blood pressure of 135 mm Hg or less [ Time Frame: Baseline (Day 1) to week 12 ]
    Proportion of subjects who achieve a mean ambulatory systolic blood pressure of 135 mm Hg or less

  3. 603A, change in seated office systolic blood pressure [ Time Frame: Baseline (Day 1) to week 12 ]
    Placebo-adjusted change in seated office systolic blood pressure

  4. 603A, seated office systolic blood pressure of 140 mm Hg or less [ Time Frame: Baseline (Day 1) to week 12 ]
    Proportion of subjects who achieve a seated office systolic blood pressure of 140 mm Hg or less

  5. 603A, change in mean ambulatory diastolic blood pressure [ Time Frame: Baseline (Day 1) to week 12 ]
    Placebo-adjusted change in mean ambulatory diastolic blood pressure

  6. 603A, mean ambulatory diastolic blood pressure of 87 mm Hg or less [ Time Frame: Baseline (Day 1) to week 12 ]
    Proportion of subjects who achieve a mean ambulatory diastolic blood pressure of 87 mm Hg or less

  7. 603A, reduction of mean ambulatory diastolic blood pressure of 4 mm Hg or greater [ Time Frame: 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

  8. 603A, change in seated office diastolic blood pressure [ Time Frame: Baseline (Day 1) to week 12 ]
    Placebo-adjusted change in seated office diastolic blood pressure

  9. 603A, seated office diastolic blood pressure of 90 mm Hg or less [ Time Frame: Baseline (Day 1) to week 12 ]
    Proportion of subjects who achieve a mean seated office diastolic blood pressure of 90 mm Hg or less

  10. 603B, change in seated office systolic blood pressure [ Time Frame: 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

  11. 603B, change in mean ambulatory diastolic blood pressure [ Time Frame: Week 12 (cumulative week 24) to Week 24 (cumulative week 36) ]
    Placebo-adjusted change in mean ambulatory diastolic blood pressure

  12. 603B, change in seated office diastolic blood pressure [ Time Frame: 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


Other Outcome Measures:
  1. Integrated 603A and 603B, effects on mean ambulatory systolic and diastolic blood pressure [ Time Frame: Baseline (Day 1) to cumulative week 36 ]
    Integration of measures collected in studies 603A and 603B will be used to assess consistent effects on mean ambulatory systolic and diastolic blood pressure after 12 weeks of bexagliflozin treatment, as well as longer treatment periods, i.e., 24 weeks or 36 weeks of bexagliflozin treatment.

  2. Integrated 603A and 603B, effects on seated office systolic and diastolic blood pressure [ Time Frame: Baseline (Day 1) to cumulative week 36 ]
    Integration of measures collected in studies 603A and 603B will be used to assess consistent effects on seated office systolic and diastolic blood pressure over time



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Male or female with age 20 years or older
  • Diagnosed with essential hypertension
  • Not taking medication or taking no more than 4 medications for hypertension

Key Exclusion Criteria:

  • Requiring insulin to control blood glucose
  • Having previously participated in a bexagliflozin or EGT0001474 study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514641


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Sponsors and Collaborators
Theracos
Investigators
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Study Director: Andrew Allegretti, M.D. Massachusetts General Hospital

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Responsible Party: Theracos
ClinicalTrials.gov Identifier: NCT03514641     History of Changes
Other Study ID Numbers: THR-1442-C-603
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases