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NCT06677060 · ClinicalTrials.gov registry record · Phase 3
Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin
A Phase 3 study of Heart Failure, sponsored by AstraZeneca.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 11,300
- Enrollment target
- 20
- Study locations
NCT06677060 is a Phase 3 study of Heart Failure that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 11,300 participants, above the 2,021-participant average among 397 other Heart Failure trials with a reported enrollment target (459% higher). The trial reports 20 study locations across 3 states.
The verdict
NCT06677060, a Phase 3 study of Heart Failure, is actively recruiting participants, sponsored by AstraZeneca.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 11,300 participants
- Enrollment target
- 20
- Study locations
Study Summary
Participants include men and women ≥ 40 years of age with T2DM, established CV disease, a history of HTN with an SBP of at least 130 mmHg at screening, who meet the predefined serum potassium level, and with at least one additional risk factor for HF. The study will include an optional pre-screening period to facilitate sites' identification of potentially eligible participants to enter the full screening assessments. Participants will not be required to visit the site and no informed consent is required for the optional pre-screening period. The pre-screening assessments do not replace the full screening tests at Visit 1. Upon entering the screening period, all consented participants (after signature of screening ICF) will be screened during an up to 14-day screening period. Participants who meet all screening inclusion/exclusion criteria but are not treated with SGLT2i or are treated for less than 4 weeks will enter a run-in period with dapagliflozin 10 mg once daily for at least 4 weeks (and not more than 6 weeks) before randomisation. Site visits will take place at approximately 2-, 4-, 8-, 16-, and 34-weeks following randomisation. Thereafter visits will occur approximately every 4 months. The study closure procedures will be initiated when the predetermined number of the first secondary endpoint events (ie, the composite of hospitalisation for HF or CV death) is predicted to have occurred i.e., the PACD. In case of premature discontinuation of the blinded study intervention, participants will remain in the study. Unless a participant meets the dapagliflozin specific discontinuation criteria, they will continue to receive open label dapagliflozin 10 mg. It is important that the scheduled study visits and data collection continue according to the study protocol.
Conditions Studied
Interventions
- DRUG Baxdrostat and dapagliflozin
- OTHER Placebo and dapagliflozin
Study Locations (20)
California
- Research Site - Dublin
- Research Site - Huntington Beach
- Research Site - Inglewood
- Research Site - La Jolla
- Research Site - Lakewood
- Research Site - Lincoln
- Research Site - Loma Linda
- Research Site - Los Angeles
- Research Site - Sacramento
- Research Site - San Diego
Alabama
- Research Site - Birmingham
- Research Site - Centreville
- Research Site - Fairhope
- Research Site - Huntsville
- Research Site - Mobile
- Research Site - Vestavia Hills
Arizona
- Research Site - Gilbert
- Research Site - Glendale
- Research Site - Tempe
- Research Site - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11,300 participants |
| Start Date | 2025-03-14 |
| Est. Completion | 2029-12-17 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06677060
The ClinicalTrials.gov registry entry for NCT06677060 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 11,300 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,021-participant average among 397 other Heart Failure trials with a reported enrollment target (459% higher). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which Baxdrostat and dapagliflozin is the first listed.
NCT06677060 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT06677060 about?
NCT06677060 is a clinical study titled "Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin". Participants include men and women ≥ 40 years of age with T2DM, established CV disease, a history of HTN with an SBP of at least 130 mmHg at screening, who meet the predefined serum potassium level, and with at least one additional risk factor for HF. The study will include an optional pre-screenin...
What is the current status of trial NCT06677060?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 11,300 participants. The study started on 2025-03-14. Estimated completion is 2029-12-17.
What conditions does trial NCT06677060 study?
This clinical trial studies the following conditions: Heart Failure.
What interventions are being tested in trial NCT06677060?
The interventions under investigation include: Baxdrostat and dapagliflozin (DRUG), Placebo and dapagliflozin (OTHER).
Who is sponsoring clinical trial NCT06677060?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06677060 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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