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Baxdrostat for High Blood Pressure (BaxHTN Trial)

Q: Could individuals aged sixty or more be participants in this experiment?

The parameters of this medical trial specify that the age range for participants is between 18 and 130 years old. Additionally, there are 52 trials available for those under 18 while 682 can join if they're over 65.

Q: What are the criteria for enrollment in this research experiment?

This clinical trial is welcoming 720 participants who meet two requirements: they must have <a href="https://www.withpower.com/clinical-trials/hypertension">hypertension</a> and be between 18 and 130 years of age.

Q: Has 2 mg baxdrostat been granted sanction by the FDA?

This drug was judged to have a safety rating of 3 since it is currently in Phase 3 clinical trials. Supporting evidence for its efficacy and safety has been gathered through multiple rounds of data collection.

Q: Is enrollment for this experiment still open to individuals?

Records on clinicaltrials.gov indicate that this medical trial, which was published on December 1st 2023 and last updated September 18th 2023, is not presently admitting patients. However, there are still 765 studies open for enrolment at the moment.

Q: In what number of medical facilities is this research study being conducted?

Currently, 142 sites are taking part in this trial. Participants can access these clinical centres from Sun City West to Anaheim and myriad other locations; it is vital that you identify the closest medical facility to your home so as to reduce travel cost.

Q: What are the desired outcomes for this experiment?

The primary objective of this study, to be evaluated over a twelve-week period, is determining the change in seated systolic blood pressure for 1 mg baxdrostat. Among other secondary objectives are assessing how 2 mg Baxdrostat alters sitting SBP and DBP at Week 12 as well as analyzing if it can reach less than 130 mmHg.

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

Male or female participants must be ≥ 18 years old

- 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 54

Awards & highlights

BaxHTN Trial Summary

This trial studies a drug to lower high blood pressure, despite current treatments, in 720 people aged 18+.

Who is the study for?

This trial is for adults with high blood pressure not controlled by at least two medications, including a diuretic. Participants must have certain levels of potassium and kidney function. It's not for those with extremely high blood pressure or secondary causes like thyroid issues or specific heart conditions.Check my eligibility

What is being tested?

The study tests Baxdrostat (1 or 2 mg daily) against a placebo in reducing systolic blood pressure. It's a Phase III trial where participants are randomly assigned to either the drug or placebo group without knowing which one they're receiving.See study design

What are the potential side effects?

While the side effects aren't listed here, typical ones may include dizziness, headache, fatigue, and potential electrolyte imbalances due to its effect on blood pressure and kidney function.

BaxHTN Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Select...

I am on two different high blood pressure medications, including a diuretic, at the highest dose I can handle.

Select...

I take 3 or more blood pressure medicines, including a diuretic, at the highest dose I can tolerate.

BaxHTN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 54

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 54

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 54 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 seated systolic blood pressure for 1 mg baxdrostat

Change from baseline in seated systolic blood pressure for 2 mg baxdrostat

Secondary outcome measures

Achieving seated SBP < 130 mmHg for 1 mg baxdrostat

Achieving seated SBP < 130 mmHg for 2 mg baxdrostat

Change from baseline in seated DBP for 1 mg baxdrostat

+6 more

Other outcome measures

Number of participants with adverse events (AEs)

BaxHTN Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: 2 mg baxdrostatExperimental Treatment1 Intervention

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

Group II: 1 mg baxdrostatExperimental Treatment1 Intervention

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

Group III: PlaceboPlacebo Group1 Intervention

Placebo administered orally, once daily (QD).

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,271 Previous Clinical Trials

288,611,983 Total Patients Enrolled

Frequently Asked Questions

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

Could individuals aged sixty or more be participants in this experiment?

"The parameters of this medical trial specify that the age range for participants is between 18 and 130 years old. Additionally, there are 52 trials available for those under 18 while 682 can join if they're over 65."

Answered by AI

What are the criteria for enrollment in this research experiment?

"This clinical trial is welcoming 720 participants who meet two requirements: they must have hypertension and be between 18 and 130 years of age."

Answered by AI

Has 2 mg baxdrostat been granted sanction by the FDA?

"This drug was judged to have a safety rating of 3 since it is currently in Phase 3 clinical trials. Supporting evidence for its efficacy and safety has been gathered through multiple rounds of data collection."

Answered by AI

Is enrollment for this experiment still open to individuals?

"Records on clinicaltrials.gov indicate that this medical trial, which was published on December 1st 2023 and last updated September 18th 2023, is not presently admitting patients. However, there are still 765 studies open for enrolment at the moment."

Answered by AI

In what number of medical facilities is this research study being conducted?

"Currently, 142 sites are taking part in this trial. Participants can access these clinical centres from Sun City West to Anaheim and myriad other locations; it is vital that you identify the closest medical facility to your home so as to reduce travel cost."

Answered by AI

What are the desired outcomes for this experiment?

"The primary objective of this study, to be evaluated over a twelve-week period, is determining the change in seated systolic blood pressure for 1 mg baxdrostat. Among other secondary objectives are assessing how 2 mg Baxdrostat alters sitting SBP and DBP at Week 12 as well as analyzing if it can reach less than 130 mmHg."

Answered by AI

Who else is applying?

What site did they apply to?

Research Site

Other

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

Why did patients apply to this trial?

Want to try a different drug. The more I know about my health conditions the healthier I will be.

PatientReceived 2+ prior treatments

Because I am not even 40 years old and I've been afflicted with stage 2 hypertension that is resistant to treatment for no less than 20 years and if I continue at this rate I will die soon.

PatientReceived 1 prior treatment

Recent research and studies

clinicaltrials.govStudy

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

2023. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06034743.

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