Clinical Trials

Numerous clinical trials evaluate the therapeutic applications of labetalol in cardiovascular and obstetric care, focusing on conditions such as severe pre-eclampsia, pregnancy-induced hypertension, postnatal hypertension, ischemic stroke, and blood pressure management during procedures like craniotomy. Spanning Early Phase 1 through Phase 4 as well as non-interventional designs, these protocols encompass active, completed, terminated, and pending recruitment statuses. Primary sponsors include major academic institutions and university medical centers such as Assiut University, Yonsei University, and Ohio State University.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07363343 RECRUITING
Hypertension; Postpartum Preeclampsia
The Cleveland Clinic
 2026-03-10
NCT06677970 RECRUITING
Acute Ischemic Stroke
Yonsei University
 2024-10-01 PHASE3
NCT05551104 RECRUITING
Postpartum Complication; Maternal Hypertension; High Blood Pressure
Loma Linda University
 2023-05-08 PHASE3
NCT06915792 RECRUITING
Postpartum Hypertension (PPHT)
University of California, Los Angeles
 2025-06-01 PHASE4
NCT05989581 RECRUITING
Hypertension in Pregnancy
University of Alabama at Birmingham
 2024-04-24 PHASE1
NCT06385600 UNKNOWN
Severe Pre-eclampsia
Assiut University
 2024-05-20
NCT06093893 COMPLETED
Hypotensive Anesthesia; Orthognathic Surgery
Boston Medical Center
 2025-03-04 PHASE4
NCT07192081 RECRUITING
Intubation; Anesthesia; Laparoscopic Cholecystectomy; Hemodynamic Response to Laryngoscopy
Dr. Waseem Ullah
 2025-06-05
NCT07364201 COMPLETED
Hemorrhagic Strokes; Postoperative Hypertension; Hemodynamic Instability
Universitas Sumatera Utara
 2025-11-14
NCT06752863 UNKNOWN
Hypotensive Anesthesia; Ear, Nose and Throat Procedure
Ain Shams University
 2024-11-27 PHASE4
NCT07034898 ENROLLING_BY_INVITATION
Airway Stress Response
Ain Shams University
 2025-04-01 PHASE4
NCT05139238 TERMINATED
Postpartum Pregnancy-Induced Hypertension; Postpartum Preeclampsia; Pregnancy-Induced Hypertension in Postpartum; Hypertensive Emergency
Columbia University
 2022-07-04 PHASE4
NCT07277283 COMPLETED
Acute Ischemic Stroke; Hypertensive Crisis
Haseki Training and Research Hospital
 2025-02-01 PHASE4
NCT04298034 ACTIVE_NOT_RECRUITING
Preeclampsia; Hypertension in Pregnancy
Medical College of Wisconsin
 2020-07-17 PHASE3
NCT06265415 UNKNOWN
Severe Preeclampsia
Sohag University
 2024-03-30
NCT06360601 UNKNOWN
Preeclampsia Severe
Tanta University
 2024-04-01 PHASE1; PHASE2
NCT07572656 COMPLETED
Preeclampsia
Muhammad Aamir Latif
 2024-05-01
NCT06346561 UNKNOWN
Nasolacrimal Duct Obstruction
Sohag University
 2024-03-30
NCT05955040 TERMINATED
Elevated Blood Pressure; Pregnancy Induced Hypertension
Marshall University
 2023-07-11 PHASE2
NCT05309460 RECRUITING
Postpartum Preeclampsia; Hypertension in Pregnancy
Nebraska Methodist Health System
 2022-06-20 PHASE4
NCT06385600 Not yet recruiting
Severe Pre-eclampsia
Assiut University
 2024-05-20 Not Applicable
NCT06346561 Recruiting
Nasolacrimal Duct Obstruction
Sohag University
 2024-03-30 Not Applicable
NCT04205305 COMPLETED
Ischemic Stroke
Yonsei University
 2020-06-18 PHASE4
NCT04484350 COMPLETED
Stroke, Acute; Vessels; Occlusion; Blood Pressure; Endovascular Thrombectomy; Mechanical Thrombectomy
Hamilton Health Sciences Corporation
 2020-10-23 PHASE2
NCT02531490 UNKNOWN
Hypertension, Pregnancy-Induced; Pre-Eclampsia
Maastricht University Medical Center
 2015-01-01 PHASE4
NCT05368376 COMPLETED
Hypotension Drug-Induced
Damanhour Teaching Hospital
 2021-04-01 PHASE4
NCT04116112 COMPLETED
Acute Stroke; Endovascular Thrombectomy
University of Cincinnati
 2020-01-17 PHASE2
NCT04343235 TERMINATED
Hypertension, Pregnancy-Induced
Wright State University
 2020-05-01 PHASE4
NCT05310929 COMPLETED
Severe Pre-eclampsia
Ain Shams University
 2019-08-28
NCT04539379 COMPLETED
Magnesium Sulfate; Labetalol
Zagazig University
 2020-10-01
NCT05096728 Completed
Preeclampsia With Severe Features
Ohio State University
 2021-12-01 --
NCT02281838 TERMINATED
Intracerebral Hemorrhage
University of Alberta
 2011-08-01 PHASE2
NCT04688203 COMPLETED
Peripheral Perfusion; Postoperative Pain
Zagazig University
 2021-02-01 PHASE1; PHASE2
NCT03872336 TERMINATED
Preeclampsia With Severe Features
Albany Medical College
 2019-02-18 PHASE4
NCT03877692 TERMINATED
Preeclampsia With Severe Features; Chronic Hypertension in Obstetric Context
Albany Medical College
 2019-02-18 PHASE4
NCT03245970 WITHDRAWN
Chronic Hypertension Complicating Pregnancy (Diagnosis); Preeclampsia
University of Tennessee Medical Center
 2017-04-24 EARLY_PHASE1
NCT03105661 UNKNOWN
Obesity, Morbid; Preeclampsia
University of Tennessee Graduate School of Medicine
 2017-04-04 EARLY_PHASE1
NCT03809065 COMPLETED
Tissue Perfusion; Deliberate Hypotension; Sinus Endoscopic Surgery
Cairo University
 2019-01-19 PHASE4
NCT03506724 COMPLETED
Hypertension in Pregnancy; Preeclampsia
Icahn School of Medicine at Mount Sinai
 2017-09-11 PHASE4
NCT03449277 UNKNOWN
Postpartum Preeclampsia
Hossam Ahmed Abd Ellah
 2018-01-19 PHASE4
NCT02997800 COMPLETED
Bloodpressure; Heart Rate
Dr. Robert Tanzola
 2012-11 PHASE2
NCT03661346 COMPLETED
Chronic Sinusitis
The University of Texas Medical Branch, Galveston
 2017-03-01 PHASE2
NCT03325348 UNKNOWN
Severe Pre-Eclampsia, Antepartum
Services Institute of Medical Sciences, Pakistan
 2017-02-23 PHASE2; PHASE3
NCT01912677 COMPLETED
Hypertension in Pregnancy; Preeclampsia
Gynuity Health Projects
 2015-04 PHASE4
NCT03059316 COMPLETED
Controlled Hypotension for Nasal Surgeries
Cairo University
 2016-06-10 EARLY_PHASE1
NCT03086265 Completed
Otorhinolaryngologic Surgical Procedures|Laser Therapy
Stanford University
 2017-03-24 Not Applicable
NCT00293735 WITHDRAWN
Preeclampsia; Pregnancy Induced Hypertension; Gestational Hypertension; Chronic Hypertension; Superimposed Preeclampsia
Baylor College of Medicine
 2015-06 PHASE2; PHASE3
NCT02933593 WITHDRAWN
Hypertension
St. Louis University
 2016-08
NCT02426177 UNKNOWN
Postnatal Hypertension
Dow University of Health Sciences
 2015-05 PHASE3
NCT02327793 COMPLETED
Stroke, Acute
University of Alberta
 2009-06 PHASE2
NCT02168309 COMPLETED
Severe Postpartum Hypertension
Cedars-Sinai Medical Center
 2014-06
NCT02050529 COMPLETED
Hypertension, Pregnancy Induced; Hydralazine Adverse Reaction; Pre-eclampsia; Pre-eclampsia Superimposed Pre-existing Hypertension
Dow University of Health Sciences
 2012-10 PHASE2
NCT01114971 COMPLETED
Laparoscopic Surgery
Cedars-Sinai Medical Center
 2009-09-03 PHASE4
NCT01538875 COMPLETED
Hypertension, Pregnancy Induced
Saint Thomas Hospital, Panama
 2012-07 PHASE3
NCT01408524 COMPLETED
Hypertension; Craniotomy
Mahidol University
 2010-02 PHASE1; PHASE2
NCT00963976 COMPLETED
Intracerebral Hemorrhage
University of Alberta
 2007-01 PHASE2
NCT00765648 COMPLETED
Hypertensive Urgency
The Cleveland Clinic
 2008-10 PHASE4
NCT01041066 UNKNOWN
Patients Who Are Intubated for General Anesthesia; Endotracheal Intubation
Seoul National University Bundang Hospital
 2009-09
NCT00226096 COMPLETED
CVA (Cerebrovascular Accident); Cerebral Hemorrhage; Intracranial Hemorrhages
The George Institute
 2005-11
NCT00194974 WITHDRAWN
Pregnancy Toxemia; Hypertension; Proteinuria
Weill Medical College of Cornell University
 2004-07 PHASE1; PHASE2
NCT00000297 COMPLETED
Tobacco Use Disorder
National Institute on Drug Abuse (NIDA)
 1998-10 PHASE2
NCT00394537 COMPLETED
Bronchoscopy
Rabin Medical Center
 PHASE4
NCT00000291 COMPLETED
Cocaine-Related Disorders
National Institute on Drug Abuse (NIDA)
 1997-10 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-03)

Check the Labetalol HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Labetalol HCl functions as a dual antagonist that selectively binds to alpha1-adrenergic receptors and nonselectively blocks beta-adrenergic receptors, thereby inhibiting catecholamine-induced activation of G protein-coupled signaling pathways and intracellular cyclic AMP accumulation. This dual receptor blockade reduces peripheral vascular resistance while dampening cardiac reflex response, resulting in lowered blood pressure and providing critical hemodynamic control in clinical conditions such as pre-eclampsia, postnatal hypertension, and acute hypertensive emergencies.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.