17 completed, 5 recruiting, 1 unknown. 11 Phase 1, 4 Phase 2, 4 Phase 3, 2 Not applicable, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 11 | Completed 10, Recruiting 1 |
| Phase 2 | 4 | Completed 2, Recruiting 2 |
| Phase 3 | 4 | Recruiting 2, Completed 1, Unknown 1 |
| Not applicable | 2 | Completed 2 |
| Phase 4 | 2 | Completed 1, Recruiting 1 |
Follow fludrocortisone acetate: new trials by email Literature Review of fludrocortisone acetate trials Research Report on fludrocortisone acetate
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Drug-Drug Interaction Study of Itraconazole and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-017) Opevesostat, Prednisone, Fludrocortisone acetate - Healthy | Phase 1 | Completed | Merck Sharp & Dohme LLC | 14 | 2026-05-11 | 2026-06-25 |
| Hydrocortisone and Fludrocortisone for the Treatment of Septic Shock Hydrocortisone plus Fludrocortisone, Standard care - Septic Shock | Phase 4 | Recruiting | Northern Jiangsu People's Hospital | 336 | 2026-03-02 | 2026-03-04 |
| A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015) Opevesostat, Fludrocortisone/ Fludrocortisone acetate, Dexamethasone/Dexamethasone acetate - Malignant Neoplasm | Phase 2 | Recruiting | Merck Sharp & Dohme LLC | 250 | 2025-08-11 | 2026-10-06 |
| A Study to Evaluate Opevesostat (MK-5684) in Male Participants With Moderate Hepatic Impairment (MK-5684-009) Opevesostat, Prednisone, Fludrocortisone acetate - Hepatic Impairment, Healthy Participants | Phase 1 | Completed | Merck Sharp & Dohme LLC | 16 | 2025-05-13 | 2026-02-24 |
| A Study to Evaluate the Effect of MK-5684 in Male Participants With Severe Renal Impairment (RI) and With End-stage Renal Disease (ESRD) (MK-5684-010) MK-5684, Prednisone, Fludrocortisone acetate - Kidney Failure, Chronic, End-Stage Kidney Disease | Phase 1 | Completed | Merck Sharp & Dohme LLC | 24 | 2025-04-07 | 2025-10-23 |
| A Drug-Drug Interaction Study of Carbamazepine and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-012) Opevesostat, Prednisone, Fludrocortisone acetate - Healthy | Phase 1 | Completed | Merck Sharp & Dohme LLC | 14 | 2024-12-18 | 2025-05-25 |
| A Study of the Absorption, Distribution, Metabolism, and Elimination of Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-008) [¹⁴C]Opevesostat, Prednisone, Fludrocortisone - Metastatic Prostate Cancer | Phase 1 | Completed | Merck Sharp & Dohme LLC | 8 | 2024-09-19 | 2024-10-23 |
| A Drug-Drug Interaction Study of Diltiazem and MK-5684 in Healthy Adult Male Participants (MK-5684-011) MK-5684, Prednisone, Fludrocortisone acetate - Prostatic Neoplasms | Phase 1 | Completed | Merck Sharp & Dohme LLC | 12 | 2024-07-11 | 2024-10-15 |
| Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A) Opevesostat, Olaparib, Docetaxel - Prostatic Neoplasms, Castration-Resistant | Phase 1 / Phase 2 | Recruiting | Merck Sharp & Dohme LLC | 220 | 2024-05-20 | 2026-10-21 |
| A Study of Opevesostat (MK-5684) in China Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (MK-5684-001) Opevesostat, Dexamethasone, Fludrocortisone - Prostatic Neoplasms, Metastatic Castration-Resistant Prostate Cancer | Phase 1 | Completed | Merck Sharp & Dohme LLC | 14 | 2024-01-30 | 2026-03-19 |
| Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) Opevesostat, Abiraterone acetate, Enzalutamide - Prostate Cancer Metastatic | Phase 3 | Recruiting | Merck Sharp & Dohme LLC | 1310 | 2023-12-31 | 2026-10-06 |
| A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004) Opevesostat, Dexamethasone, Fludrocortisone acetate - Metastatic Castration-resistant Prostate Cancer (mCRPC), Prostatic Neoplasms | Phase 3 | Recruiting | Merck Sharp & Dohme LLC | 1314 | 2023-12-18 | 2026-10-20 |
| A Study of Opevesostat (MK-568)4 in Japanese Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-005) Opevesostat, Dexamethasone, Fludrocortisone acetate - Prostatic Neoplasms, Metastatic Castration-Resistant Prostate Cancer | Phase 1 | Completed | Merck Sharp & Dohme LLC | 7 | 2023-11-14 | 2026-04-27 |
| Mineralocorticoid Use in COVID-19 Patients Fludrocortisone Acetate 0.1 MG - COVID-19, ARDS | Phase 3 | Completed | Ain Shams University | 10 | 2021-12-04 | 2022-07-12 |
| Fludrocortisone Dose Response Relationship in Septic Shock - FluDReSS Fludrocortisone Acetate, Standard Therapy - Critically Ill, Septic Shock | Phase 2 | Completed | The George Institute | 155 | 2021-02-11 | 2024-01-18 |
| Midodrine and Fludrocortisone for Vasovagal Syncope Midodrine Hydrochloride Tablets, Fludrocortisone Acetate Tablets, Lifestyle modification - Syncope, Vasovagal | Phase 3 | Unknown | Tehran Heart Center | 1375 | 2020-11-19 | 2021-04-19 |
| The Role of Minerelocorticoid Receptor on Modulating Aldosterone Production Placebo, Fludrocortisone, Eplerenone - Healthy Volunteers | Phase 1 | Completed | Brigham and Women's Hospital | 23 | 2016-01-01 | 2021-06-08 |
| Effects of Mineralocorticoid Receptor Stimulation on Cognition Fludrocortisone - Individuality | Not applicable | Completed | Charite University, Berlin, Germany | 80 | 2015-05-01 | 2016-03-07 |
| Influence of Polymorphisms in the ATP6V1 Gene of the V-ATPase on the Development of Incomplete Distal Renal Tubular Acidosis Furosemide-Fludrocortisone-Test (test for urinary acidification) - Acidosis, Renal Tubular, Nephrolithiasis | Completed | Insel Gruppe AG, University Hospital Bern | 170 | 2012-09-01 | 2018-10-09 | |
| Orthostatic Dysregulation and Associated Gastrointestinal Dysfunction in Parkinson's Disease -Treatment Pyridostigmine bromide, fludrocortisone - Autonomic Disturbances in Parkinson's Disease | Phase 2 | Completed | Christian Baumann | 18 | 2012-06-01 | 2021-01-25 |
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Prostatic Neoplasms (5) · Shock, Septic (2) · Syncope, Vasovagal (2) · Acidosis, Renal Tubular (1) · COVID-19 (1) · Critical Illness (1) · Depression (1) · Hypotension (1) · Hypotension, Orthostatic (1) · Kidney Calculi (1) · Kidney Failure, Chronic (1) · Neoplasms (1) · Nephrolithiasis (1) · Prostatic Neoplasms, Castration-Resistant (1) · Syncope (1)
Merck Sharp & Dohme LLC (12) · Ain Shams University (1) · Brigham and Women's Hospital (1) · Charite University, Berlin, Germany (1) · Christian Baumann (1) · Insel Gruppe AG, University Hospital Bern (1) · Leiden University Medical Center (1) · Northern Jiangsu People's Hospital (1) · Tehran Heart Center (1) · The George Institute (1) · University of Calgary (1) · VA Office of Research and Development (1)
United States (12) · Canada (5) · United Kingdom (5) · Australia (4) · Chile (4) · China (4) · Germany (4) · Japan (4) · Spain (4) · Taiwan (4) · Turkey (Türkiye) (4) · Brazil (3) · Colombia (3) · France (3) · Ireland (3)
Arash Jalali, PhD (1) · Arya Aminorroaya, MD, MPH (1) · Christian Baumann, MD (1) · Daniel Fuster, Attending physician Nephrology (1) · Hamed Tavolinejad, MD (1) · James Walsham, MB ChB, MRCP, FCICM. (1) · Jonathan S Williams, MD, MMSc (1) · Katja Wingenfeld, PhD (1) · Muhammad S Zeafan (1) · Qingquan Lyu, Master (1) · Robert S. Sheldon, MD PhD (1) · Saeed Sadeghian, MD (1) · Willem van der Does, Professor (1)
PMID 41732008, PMID 16781217, PMID 27364043, PMID 28224720, PMID 29766871, PMID 39235623, PMID 42581762
2023 (3)