Hydralazine

Generic Name: Hydralazine

Brand Names: Apresoline, Bidil

Drug Type: Small Molecule

Chemical Formula: C_₈H_₈N_₄

CAS Number: 86-54-4

Unique Ingredient Identifier: 26NAK24LS8

Background: Originally developed in the 1950s as a malaria treatment, hydralazine showed antihypertensive ability and was soon repurposed. Hydralazine is a hydrazine derivative vasodilator used alone or as adjunct therapy in the treatment of hypertension and only as adjunct therapy in the treatment of heart failure. Hydralazine is no longer a first line therapy for these indications since the development of newer antihypertensive medications.

Hydralazine hydrochloride was FDA approved on 15 January 1953.

Indication: Hydralazine is indicated alone or adjunct to standard therapy to treat essential hypertension. A combination product with isosorbide dinitrate is indicated as an adjunct therapy in the treatment of heart failure.

Associated Conditions: Heart Failure, Hypertension, Essential Hypertension, Hypertensive crisis, Severe Hypertension

Clinical Trials

Intravenous Labetalol Versus Hydralazine in Preeclampsia

Phase 1

Recruiting

Conditions: Preeclampsia Severe

Interventions: Drug: Labetalol Injection
Drug: HydrALAZINE Injection

First Posted Date: 2024-04-11

Last Posted Date: 2024-12-02

Lead Sponsor: Tanta University

Target Recruit Count: 40

Registration Number: NCT06360601

Locations: 🇪🇬
Tanta Univeristy hospitals, Tanta, Egypt

Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts

Phase 4

Recruiting

Conditions: Heart Failure, Congestive

Interventions: Drug: sacubitril/valsartan
Drug: Furosemide
Drug: Hydralazine
Drug: Torsemide
Drug: Bumetanide
Drug: Isosorbide Dinitrate

First Posted Date: 2024-01-23

Last Posted Date: 2024-01-29

Lead Sponsor: Heart Center Research, LLC

Target Recruit Count: 80

Registration Number: NCT06218199

Locations: 🇺🇸
Heart Center Research, LLC, Huntsville, Alabama, United States

Effect of Hydralazine on Alzheimer's Disease

Phase 3

Conditions: Alzheimer Disease

Interventions: Drug: Placebo
Drug: Hydralazine hydrochloride 25mg tablets

First Posted Date: 2021-04-13

Last Posted Date: 2022-01-06

Lead Sponsor: Shahid Sadoughi University of Medical Sciences and Health Services

Target Recruit Count: 424

Registration Number: NCT04842552

Locations: 🇮🇷
Adineh Health Centre, Yazd, Iran, Islamic Republic of

Blood Pressure Management in Stroke Following Endovascular Treatment

Phase 2

Completed

Conditions: Stroke, Acute
Vessels; Occlusion
Blood Pressure
Endovascular Thrombectomy
Mechanical Thrombectomy

Interventions: Drug: Labetalol
Drug: Hydralazine
Drug: Enalapril

First Posted Date: 2020-07-23

Last Posted Date: 2023-11-07

Lead Sponsor: Hamilton Health Sciences Corporation

Target Recruit Count: 30

Registration Number: NCT04484350

Locations: 🇨🇦
Hamilton General Hospital, Hamilton, Ontario, Canada

Efficacy of Nifedipine Versus Hydralazine in Management of Severe Hypertension in Pregnancy

Not Applicable

Completed

Conditions: Hypertension

Interventions: Drug: Nifedipine
Drug: Hydralazine

First Posted Date: 2020-06-17

Last Posted Date: 2020-06-17

Lead Sponsor: Adebayo Joshua Adeniyi

Target Recruit Count: 69

Registration Number: NCT04435210

Locations: 🇳🇬
Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Ebonyi, Nigeria

Blood Pressure After Endovascular Stroke Therapy-II

Phase 2

Completed

Conditions: Endovascular Thrombectomy
Acute Stroke

Interventions: Drug: Nicardipine
Drug: Labetalol
Drug: Hydralazine

First Posted Date: 2019-10-04

Last Posted Date: 2023-10-12

Lead Sponsor: University of Cincinnati

Target Recruit Count: 120

Registration Number: NCT04116112

Locations: 🇺🇸
Hartford Healthcare, Hartford, Connecticut, United States
🇺🇸
University of Cincinnati, Cincinnati, Ohio, United States
🇺🇸
Vanderbilt University Medical Center, Nashville, Tennessee, United States

DANHEART (H-HeFT and Met-HeFT)

Phase 4

Recruiting

Conditions: Heart Failure
Diabetes

Interventions: Drug: Hydralazine Isosorbide Dinitrate
Drug: Placebo Oral Tablet
Drug: Metformin Hydrochloride

First Posted Date: 2018-05-02

Last Posted Date: 2025-05-18

Lead Sponsor: Henrik Wiggers

Target Recruit Count: 1500

Registration Number: NCT03514108

Locations: 🇩🇰
Sygehus Sønderjylland, Aabenraa, Aabenraa, Denmark
🇩🇰
Aalborg University Hospital, Aalborg, Denmark
🇩🇰
Aarhus University Hospital, Aarhus, Denmark

and more 22 locations

Assessing a Dose-Response Relationship of Hydralazine and Its Effects on DNA Methyltransferase 1 in Polycystic Kidney Disease Patients

Early Phase 1

Completed

Conditions: Polycystic Kidney Diseases

Interventions: Drug: Hydralazine

First Posted Date: 2018-02-06

Last Posted Date: 2020-02-26

Lead Sponsor: University of Kansas Medical Center

Target Recruit Count: 14

Registration Number: NCT03423810

Locations: 🇺🇸
University of Kansas Medical Center, Kansas City, Kansas, United States

Changes in Central Arterial Pressure When Comparing ACOG Hypertensive Urgency Protocols

Not Applicable

Withdrawn

Conditions: Hypertension

Interventions: Drug: Hydralazine
Drug: Labetalol
Drug: nifedipine

First Posted Date: 2016-10-14

Last Posted Date: 2017-11-13

Lead Sponsor: St. Louis University

Registration Number: NCT02933593

Pharmacodynamic and Pharmacokinetic Study of BiDil Extended-release Capsules and Commercial BiDil Tablets

Phase 1

Completed

Conditions: Heart Failure

Interventions: Drug: BiDil XR
Drug: BiDil Immediate Release (IR)

First Posted Date: 2015-08-13

Last Posted Date: 2016-11-08

Lead Sponsor: Arbor Pharmaceuticals, Inc.

Target Recruit Count: 12

Registration Number: NCT02522208

Locations: 🇺🇸
Morehouse School of Medicine, Atlanta, Georgia, United States
🇺🇸
Pinnacle Research Group, LLC, Anniston, Alabama, United States
🇺🇸
Jacksonville Center for Clinical Research, Jacksonville, Florida, United States

and more 2 locations

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