Trial · NCT07007793
Parent Study: A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism Sub-study: A Follow-up Substudy After Completion of the BaxPA Main Study.
NCT07007793, Phase 3, Active not recruiting, AstraZeneca
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Parent Study: A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism Sub-study: A Follow-up Substudy After Completion of the BaxPA Main Study. Trials, record NCT07007793. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07007793
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Parent Study: A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism Sub-study: A Follow-up Substudy After Completion of the BaxPA Main Study.
- NCT number
- NCT07007793
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 212 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Primary Hyperaldosteronism
- Interventions
- Baxdrostat, Placebo
- First posted
- 2025-06-06
- Last updated
- 2026-10-16
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in seated Systolic Blood Pressure (SBP) at Week 8 | At week 8 | To assess the effect of baxdrostat versus placebo on seated Systolic Blood Pressure (SBP) at Week 8 |
| Primary | Achieving normalization of renin at week 8 in participants with dysregulated renin at baseline | At week 8 | To assess the effect of baxdrostat vs placebo on achieving normalization of renin at week 8, in participants with dysregulated renin at baseline |
| Secondary | Percent change from RWD baseline (Week 44) in Direct Renin Concentration (DRC) at Week 52 | At week 52 | To assess the effect of baxdrostat versus placebo on the percent change in DRC 8 weeks after the start of RWD |
| Secondary | Change from Randomised withdrawal (RWD) baseline (Week 44) in seated Systolic Blood Pressure (SBP) at Week 52 | At week 52 | To assess the effect of baxdrostat versus placebo on seated Systolic Blood Pressure (SBP) 8 weeks after the start of Randomised withdrawal (RWD) |
| Secondary | Percent change from baseline in Renin at week 8 | At week 8 | To assess the effect of baxdrostat versus placebo in the change from baseline in renin at week 8. |
| Secondary | Achieving serum potassium ≥ 3.7 mmol/L without potassium supplementation at Week 8 in participants with serum potassium < 3.7 mmol/L or potassium supplementation at baseline | At week 8 | To assess the effect of baxdrostat versus placebo on achieving serum potassium ≥ 3.7 mmol/L without potassium supplementation at Week 8 in participants with serum potassium \< 3.7 mmol/L or potassium supplementation at baseline |
| Secondary | Achieving 24-hour urine aldosterone < 10 μg at Week 8 in participants with 24-hour urine aldosterone ≥ 10 μg at baseline | At week 8 | To assess the effect of baxdrostat versus placebo on achieving 24-hour urine aldosterone \< 10 μg at Week 8 in participants with 24-hour urine aldosterone ≥ 10 μg at baseline |
| Secondary | Percent change from baseline in 24-hour urine albumin at Week 8 | At week 8 | To assess the effect of baxdrostat versus placebo on 24-hour urine albumin at Week 8 |
| Other | Number of participants with adverse events (AEs) | up to 54 weeks | To assess the safety and tolerability of baxdrostat. Occurrence of Adverse Events (AEs), Serious Adverse Events (SAEs), deaths, AEs leading to discontinuation of IMP and adverse events of special interest (AESIs) (hyperkalemia and hyponatremia) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07007793
GET https://conductscience.org/api/trials/v1/NCT07007793/registered