A clinical research study to learn if baxdrostat works at reducing ambulatory blood pressure and is safe for 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

29 Apr 2024 → 17 Aug 2025

Decision date (initial)

2024-04-15

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AstraZeneca AB

External identifiers

EU CT number

2023-507640-36-00

ClinicalTrials.gov

NCT06168409

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacokinetic, Therapy, Pharmacogenomic, Pharmacodynamic

To assess the effect of treatment with baxdrostat 2 mg vs placebo on ambulatory 24-hour average systolic blood pressure (SBP) at Week 12.

Secondary objectives 9

1. To assess the effect of treatment with baxdrostat 2 mg vs placebo on ambulatory night-time average SBP at Week 12
2. To assess the effect of treatment with baxdrostat 2 mg vs placebo on ambulatory daytime average SBP at Week 12
3. To assess the effect of treatment with baxdrostat 2 mg vs placebo on seated SBP at Week 12
4. To assess the effect of treatment with baxdrostat 2 mg vs placebo on achieving ambulatory 24-hour average SBP < 130 mmHg at Week 12
5. To assess the effect of treatment with baxdrostat 2 mg vs placebo on ambulatory 24-hour average DBP at Week 12
6. To assess the effect of treatment with baxdrostat 2 mg vs placebo on ambulatory night-time average DBP at Week 12
7. To assess the effect of treatment with baxdrostat 2 mg vs placebo on ambulatory daytime average DBP at Week 12
8. To assess the effect of treatment with baxdrostat 2 mg vs placebo on seated DBP at Week 12
9. To assess the effect of treatment with baxdrostat 2 mg vs placebo in the nocturnal dipping pattern at Week 12

Conditions and MedDRA coding

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

Federal Institute For Drugs And Medical Devices

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. Participant must be ≥ 18 years old, at the time of signing the informed consent.
2. Mean seated SBP on AOBPM of ≥ 140 mmHg and < 170 mmHg at Screening.
3. 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, for at least 4 weeks prior to Screening. Beta blockers used to treat other conditions (ie, migraine, HF, coronary artery disease) should not be counted as an antihypertensive medication for the purpose of qualifying for this study.
4. Have eGFR ≥ 45 mL/min/1.73 m2 at Screening.
5. Serum potassium (K+) level ≥ 3.5 and < 5.0 mmol/L at Screening, determined as per central laboratory
6. Randomization Criteria: mean ambulatory SBP of ≥ 130 mmHg at randomisation.

Exclusion criteria 6

1. Mean seated SBP on AOBPM ≥ 170 mmHg.
2. Mean seated DBP on AOBPM ≥ 110 mmHg
3. Serum sodium level < 135 mmol/L at Screening, as per central laboratory.
4. Known secondary causes of hypertension.
5. New York Heart Association functional HF class IV
6. Persistent atrial fibrillation.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline in ambulatory 24‑hour average SBP at Week 12.

Secondary endpoints 9

1. Change from baseline in ambulatory night-time average SBP at Week 12.
2. Change from baseline in ambulatory daytime average SBP at Week 12.
3. Change from baseline in seated SBP at Week 12.
4. Participants achieving ambulatory 24-hour average SBP of < 130 mmHg at Week 12.
5. Change from baseline in ambulatory 24-hour average DBP at Week 12.
6. Change from baseline in ambulatory night-time average DBP at Week 12.
7. Change from baseline in ambulatory daytime average DBP at Week 12.
8. Change from baseline on seated DBP at Week 12.
9. Participants achieving a nocturnal SBP dipping of ≥ 10% at Week 12

Investigational products

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

Test 1

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

9 EU/EEA countries · 47 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 83 files

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

Application history

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