A study to learn if baxdrostat works at reducing blood pressure and is safe in people with high blood pressure

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Astrazeneca AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

8 Mar 2024 → 10 Oct 2025

Decision date (initial)

2024-02-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AstraZeneca AB

External identifiers

EU CT number

2023-505499-32-00

ClinicalTrials.gov

NCT06034743

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacokinetic, Pharmacodynamic, Dose response, Therapy

To assess the effect of 2 mg baxdrostat versus placebo on seated systolic blood pressure at week 12.
To assess the effect of 1 mg baxdrostat versus placebo on seated systolic blood pressure at week 12.
Safety: To assess the safety and tolerability of baxdrostat versus placebo.

Secondary objectives 7

1. To assess the effect of 2 mg baxdrostat vs placebo on seated systolic blood pressure (SBP) at 8 weeks after randomised withdrawal.
2. To assess the effect of 2 mg baxdrostat vs placebo on seated SBP at Week 12 in the resistant hypertension (rHTN) subpopulation.
3. To assess the effect of 2 mg baxdrostat vs placebo on seated diastolic blood pressure (DBP) at Week 12.
4. To assess the effect of 2 mg baxdrostat vs placebo on achieving seated SBP < 130 mmHg at Week 12.
5. To assess the effect of 1 mg baxdrostat vs placebo on seated SBP at Week 12 in the rHTN subpopulation.
6. To assess the effect of 1 mg baxdrostat vs placebo on seated DBP at Week 12.
7. To assess the effect of 1 mg baxdrostat vs placebo on achieving seated SBP < 130 mmHg at Week 12.

Conditions and MedDRA coding

Uncontrolled hypertension (uTHN) defined as blood pressure that remains higher than goal levels despite patients being treated with 2 anti-hypertensive agents, including a diuretic. Resistant hypertension (rHTN) defined as blood pressure that remains higher than goal levels despite the use of at least 3 anti hypertensive drugs of different classes at maximum tolerated dose, including a diuretic.

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Federal Institute For Drugs And Medical Devices, Food And Drug Administration

Plan to share IPD

Yes

IPD 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 shared. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Male or female participants must be ≥ 18 years old.
2. Mean sitting systolic blood pressure on automated office blood pressure measurement ≥ 140 mmHg and < 170 mmHg at Screening.
3. Fulfil at least 1 of the following 2 criteria: a) uHTN subpopulation: have a stable regimen of 2 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator b) rHTN subpopulation: have a stable regimen of ≥ 3 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator
4. Estimated glomerular filtration rate ≥ 45 mL/min/1.73m2 at Screening.
5. Serum potassium (K+) level ≥ 3.5 and < 5.0 mmol/L at Screening
6. Randomisation Criterion: Sitting systolic blood pressure on attended automated office blood pressure measurement of ≥ 135 mmHg at baseline.

Exclusion criteria 6

1. Mean sitting systolic blood pressure on attended automated office blood pressure measurement ≥ 170 mmHg at Randomisation.
2. Mean seated diastolic blood pressure on attended automated office blood pressure measurement ≥ 110 mmHg at Randomisation.
3. Serum sodium level < 135 mmol/L at Screening.
4. 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.
5. New York Heart Association functional heart failure class IV at Screening.
6. Persistent atrial fibrillation.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Change from baseline in seated systolic blood pressure for 2 mg baxdrostat.
2. Change from baseline in seated systolic blood pressure for 1 mg baxdrostat.
3. Safety and tolerability will be evaluated in terms of AEs, vital signs, clinical and laboratory assessments.

Secondary endpoints 7

1. Change from randomised withdrawal baseline (Week 24) in seated systolic blood pressure (SBP) for 2 mg baxdrostat.
2. Change from baseline in seated SBP for 2 mg baxdrostat.
3. Change from baseline in seated diastolic blood pressure (DBP) for 2 mg baxdrostat.
4. Achieving seated SBP < 130 mmHg for 2 mg baxdrostat.
5. Change from baseline in seated SBP for 1 mg baxdrostat.
6. Change from baseline in seated DBP for 1 mg baxdrostat.
7. Achieving seated SBP < 130 mmHg for 1 mg baxdrostat.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Astrazeneca AB

Sponsor organisation

Astrazeneca AB

Address

Astraallen Gartuna, Karlebyhus Byggnad 674 Karlebyhus Byggnad 674

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

Astrazeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Public contact point

Organisation

Astrazeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Locations

14 EU/EEA countries · 108 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 126 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

18 submissions — initial application plus substantial / non-substantial modifications