Drugs / Methyldopa
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ALDORIL 15 | — | 1962-12-20 | fda.gov ↗ |
Trials 7 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00194974 | Jul 2004 → Mar 2005 | proteinuria, toxemia of pregnancy | Weill Medical College of Cornell University | Withdrawn | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT03396484 | Sep 2020 → Mar 2022 | type 1 diabetes mellitus | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Withdrawn | No outcome recorded |
| Phase 2 | NCT01674127 | Aug 2011 → Feb 2012 | mild pre-eclampsia | Isfahan University of Medical Sciences | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT04835233 | May 2021 → Dec 2022 | preeclampsia | Federal University of Paraíba | Completed | No outcome recorded |
| Phase 4 | NCT01912677 | Apr 2015 → Sep 2017 | preeclampsia | Gynuity Health Projects | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT01911494 | Sep 2013 → May 2018 | preeclampsia | University of British Columbia | Completed | No outcome recorded |
| — | NCT01883804 | Jun 2013 → Feb 2016 | type 1 diabetes mellitus | University of Colorado, Denver | Completed | No outcome recorded |
Also used as a comparator or background therapy in 7 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00580619 Comparator | Apr 2007 → Jan 2017 | myalgic encephalomeyelitis/chronic fatigue syndrome, orthostatic hypotension, postural orthostatic tachycardia syndrome | Vanderbilt University | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT07044232 Background | Oct 2025 → Sep 2026 expected | intracerebral hemorrhage | Aarhus University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT02531490 Comparator | Jan 2015 → Feb 2023 | preeclampsia | Maastricht University Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT01500590 Comparator | Nov 2011 → Aug 2018 | hypertensive disorder, type 2 diabetes mellitus | Hospital Authority, Hong Kong | Unknown | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT06618521 Background | Sep 2024 → Sep 2025 | hypertension, pregnancy-induced | Cairo University | Completed | No outcome recorded |
| — | NCT00329511 Comparator | Sep 2004 → Dec 2008 | hypertensive disorder | Afshan B. Hameed, M.D. | Withdrawn | No outcome recorded |
| — | NCT00684489 Comparator | Sep 2003 → Mar 2005 | essential hypertension | Medical University of South Carolina | Completed | No outcome recorded |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | methyldopa | “amlodipine 2.5 to 10 mg once daily nifedipine retard 20mg to 40mg twice daily indapamide 2.5mg once daily metoprolol 25mg to 100mg daily methyldopa 125 mg to 500mg twice daily” NCT01500590 ↗14“maintaining postpartum the use of methyldopa 250 mg 01 tablet every 8 hours, being able to double the dose depending on pressure levels, up to 15 days postpartum” NCT04835233 ↗ “Methyldopa: Dose: 250 mg three times daily (max 500 mg four times daily) orally or via feeding tube” NCT07044232 ↗ “clonidine, clonidine patch, methyldopa, reserpine, guanfacine” NCT00684489 ↗ |
| Known as | Aldomet | “orally administered methyldopa (Aldomet®)” NCT00329511 ↗ |
| Action | Activate | “It is a central alpha-adrenergic agonist that decreases peripheral sympathetic outflow” NCT00329511 ↗ |
| Route | Oral | “orally administered methyldopa” NCT00329511 ↗ |