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2 mg baxdrostat for High Blood Pressure (Hypertension) (Bax24 Trial)

Phase 3

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Randomization Criteria: mean ambulatory SBP of ≥ 130 mmHg at randomisation

Participant must be ≥ 18 years old, at the time of signing the informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 12

Awards & highlights

Bax24 Trial Summary

"This trial will test the safety and effectiveness of a new medication, Baxdrostat, in reducing high blood pressure in 212 participants with resistant hypertension. The participants will be randomly assigned to either receive

Who is the study for?

This trial is for adults with resistant hypertension, meaning their blood pressure remains high despite taking at least three different blood pressure medications, including a diuretic. They must have specific levels of kidney function and potassium in their blood to join.Check my eligibility

What is being tested?

The study tests Baxdrostat's ability to lower systolic blood pressure compared to a placebo. Participants will be randomly assigned to receive either the drug or placebo once daily, and their 24-hour ambulatory blood pressure will be monitored.See study design

What are the potential side effects?

While the side effects are not detailed here, common ones associated with new antihypertensive drugs may include dizziness, headache, fatigue, low blood pressure (hypotension), and possible electrolyte imbalances.

Bax24 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My average walking blood pressure is 130 mmHg or higher.

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I am 18 years old or older.

Bax24 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in ambulatory 24-hour average SBP

Secondary outcome measures

Achieving a nocturnal SBP dipping of ≥ 10%

Change from baseline in ambulatory 24-hour average DBP

Change from baseline in ambulatory daytime average SBP

+6 more

Bax24 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 2 mg baxdrostatExperimental Treatment1 Intervention

2 mg baxdrostat administered orally, once daily (QD).

Group II: PlaceboPlacebo Group1 Intervention

Placebo administered orally, once daily (QD)

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,274 Previous Clinical Trials

288,613,152 Total Patients Enrolled

2 Trials studying High Blood Pressure (Hypertension)

3,358 Patients Enrolled for High Blood Pressure (Hypertension)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers actively seeking participants for this ongoing clinical trial?

"The search on clinicaltrials.gov shows that this study is currently seeking volunteers. This trial was initially listed on March 1st, 2024 and last modified on April 22nd, 2024."

Answered by AI

At how many different sites is this medical study being administered?

"At present, patient recruitment is ongoing at 79 sites including Angeles City, Iloilo City, Bronx and various other locations. Opting for the nearest clinical site can reduce travel requirements for enrolled participants."

Answered by AI

Has the FDA given its approval for the use of 2 mg baxdrostat?

"The safety rating for 2 mg of baxdrostat, as evaluated by our team at Power on a scale from 1 to 3, is graded as a level 3. This assessment aligns with the trial being in its Phase 3 stage, indicating existing efficacy data and robust safety evidence gathered through multiple evaluations."

Answered by AI

Is it possible for me to enroll as a participant in this research study?

"Eligibility Criteria:"

Answered by AI

What is the current number of individuals who are being enrolled in this clinical investigation?

"Indeed, as per the details on clinicaltrials.gov, this investigation is presently in search of volunteers. The trial was initially disclosed on March 1st, 2024 and last revised on April 22nd, 2024. A total of 212 individuals are sought from a network of 79 sites."

Answered by AI