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A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension (BaxHTN)

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ClinicalTrials.gov Identifier: NCT06034743
Recruitment Status : Recruiting
First Posted : September 13, 2023
Last Update Posted : April 11, 2024
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered once daily (QD) orally, on the reduction of systolic blood pressure in approximately 720 participants aged ≥ 18 years with hypertension, despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (treatment-resistant hypertension).

Condition or disease Intervention/treatment Phase
Uncontrolled Hypertension Resistant Hypertension Drug: Baxdrostat Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension
Actual Study Start Date : November 22, 2023
Estimated Primary Completion Date : October 13, 2025
Estimated Study Completion Date : October 13, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 2 mg baxdrostat
2 mg baxdrostat administered orally, once daily (QD).
 Drug: Baxdrostat

Baxdrostat tablet administered orally, once daily (QD). Unit dose strengths:

  • 1 mg per tablet for 1 mg baxdrostat Arm;
  • 2 mg per tablet for 2 mg baxdrostat Arm.
Other Name: CIN-107
Experimental: 1 mg baxdrostat
1 mg baxdrostat administered orally, once daily (QD).
 Drug: Baxdrostat

Baxdrostat tablet administered orally, once daily (QD). Unit dose strengths:

  • 1 mg per tablet for 1 mg baxdrostat Arm;
  • 2 mg per tablet for 2 mg baxdrostat Arm.
Other Name: CIN-107
Placebo Comparator: Placebo
Placebo administered orally, once daily (QD).
 Drug: Placebo
Placebo tablet matching baxdrostat, administered orally, once daily (QD).


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in seated systolic blood pressure for 2 mg baxdrostat [ Time Frame: At Week 12 ]
    To assess the effect of 2 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12

  2. Change from baseline in seated systolic blood pressure for 1 mg baxdrostat [ Time Frame: At Week 12 ]
    To assess the effect of 1 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12


Secondary Outcome Measures :
  1. Change from randomised withdrawal baseline (Week 24) in seated systolic blood pressure (SBP) for 2 mg baxdrostat [ Time Frame: At Week 32 ]
    To assess the effect of 2 mg baxdrostat vs placebo on seated systolic blood pressure (SBP) at 8 weeks after randomised withdrawal

  2. Change from baseline in seated SBP for 2 mg baxdrostat [ Time Frame: At Week 12 ]
    To assess the effect of 2 mg baxdrostat vs placebo on seated SBP at Week 12 in the resistant hypertension (rHTN) subpopulation

  3. Change from baseline in seated diastolic blood pressure (DBP) for 2 mg baxdrostat [ Time Frame: At Week 12 ]
    To assess the effect of 2 mg baxdrostat vs placebo on seated diastolic blood pressure (DBP) at Week 12

  4. Achieving seated SBP < 130 mmHg for 2 mg baxdrostat [ Time Frame: At Week 12 ]
    To assess the effect of 2 mg baxdrostat vs placebo on achieving seated SBP < 130 mmHg at Week 12

  5. Change from baseline in seated SBP for 1 mg baxdrostat [ Time Frame: At Week 12 ]
    To assess the effect of 1 mg baxdrostat vs placebo on seated SBP at Week 12 in the rHTN subpopulation

  6. Change from baseline in seated DBP for 1 mg baxdrostat [ Time Frame: At Week 12 ]
    To assess the effect of 1 mg baxdrostat vs placebo on seated DBP at Week 12

  7. Achieving seated SBP < 130 mmHg for 1 mg baxdrostat [ Time Frame: At Week 12 ]
    To assess the effect of 1 mg baxdrostat vs placebo on achieving seated SBP < 130 mmHg at Week 12

  8. The change from baseline in the mean ambulatory 24-hour SBP as measured by ambulatory blood pressure monitoring (ABPM) for 2 mg baxdrostat [ Time Frame: At Week 12 ]
    To assess the effect of treatment with baxdrostat 2 mg vs placebo on ambulatory 24-hour average SBP at Week 12

  9. The change from baseline in the mean ambulatory 24-hour SBP as measured by ABPM for 1 mg baxdrostat [ Time Frame: At Week 12 ]
    To assess the effect of treatment with baxdrostat 1 mg vs placebo on ambulatory 24-hour average SBP at Week 12


Other Outcome Measures:
  1. Number of participants with adverse events (AEs) [ Time Frame: Up to Week 54 ]
    To assess the safety and tolerability of baxdrostat versus placebo. Occurrence of adverse events (AE), including serious adverse events (SAEs), adverse events leading to treatment discontinuation (DAE) and adverse events of special interest (AESI).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female participants must be ≥ 18 years old
  • Mean sitting systolic blood pressure on automated office blood pressure measurement ≥ 140 mmHg and < 170 mmHg at Screening

  • Fulfil at least 1 of the following 2 criteria:

    1. uHTN subpopulation: have a stable regimen of 2 antihypertensive medications, from different therapeutic classes (at least one should be a diuretic), at maximum tolerated dose in the judgement of the Investigator
    2. rHTN subpopulation: have a stable regimen of ≥ 3 antihypertensive medications, from different therapeutic classes (at least one should be a diuretic), at maximum tolerated dose in the judgement of the Investigator
  • Estimated glomerular filtration rate ≥ 45 mL/min/1.73m2 at Screening
  • Serum potassium (K+) level ≥ 3.5 and < 5.0 mmol/L at Screening
  • Randomisation Criterion:
  • Sitting systolic blood pressure on attended automated office blood pressure measurement of ≥ 135 mmHg at baseline

Exclusion Criteria:

  • Mean sitting systolic blood pressure on attended automated office blood pressure measurement ≥ 170 mmHg at Randomisation
  • Mean seated diastolic blood pressure on attended automated office blood pressure measurement ≥ 110 mmHg at Randomisation
  • Serum sodium level < 135 mmol/L at Screening
  • Has the following known secondary causes of hypertension: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation
  • New York Heart Association functional heart failure class IV at Screening
  • Persistent atrial fibrillation
Contacts and Locations
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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): NCT06034743


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Sponsors and Collaborators
AstraZeneca
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT06034743    
Other Study ID Numbers: D6970C00002
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: April 11, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame:

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Hypertension
Uncontrolled hypertension
Resistant hypertension
Blood pressure
 Baxdrostat
CIN-107
Aldosterone
Aldosterone synthase
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases