Clinical Trials

Numerous clinical trials spanning Phase I through Phase IV evaluate nifedipine across a range of cardiovascular, renal, and obstetric conditions, including essential hypertension, severe preeclampsia, post-natal hypertension, and chronic kidney disease. Sponsored by academic institutions such as Ohio State University and St. Louis University alongside industrial sponsors like Bayer, these completed, recruiting, and withdrawn studies investigate optimized dosing regimens for preeclampsia management and combination therapies for systemic blood pressure regulation.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07363343 RECRUITING
Hypertension; Postpartum Preeclampsia
The Cleveland Clinic
 2026-03-10
NCT06220721 RECRUITING
Hypertension, Pregnancy-Induced
Medical College of Wisconsin
 2024-10-23
NCT07023003 RECRUITING
Hypertension in Pregnancy
Nebraska Methodist Health System
 2025-07-11 PHASE4
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
NCT07659665 NOT_YET_RECRUITING
Hemorrhoids; Postoperative Pain; Wound Healing; Analgesia
Sana'a University
 2026-08-01 PHASE4
NCT03976063 ACTIVE_NOT_RECRUITING
Preterm Premature Rupture of Membrane
Assistance Publique - Hôpitaux de Paris
 2019-10-07 PHASE3
NCT07649668 COMPLETED
Preterm Labor
Dr Mudassar Saeed Pansota
 2025-11-30 PHASE4
NCT05687344 ACTIVE_NOT_RECRUITING
Hypertensive Disorder of Pregnancy
Medical College of Wisconsin
 2023-09-01 PHASE3
NCT07523295 COMPLETED
Preterm Labor With Intact Membranes; Preterm Birth
Medicare Hospital (Pvt) Limited
 2025-05-06 PHASE4
NCT05345132 UNKNOWN
Threatened Preterm Labor
Assiut University
 2022-04-10
NCT05139238 TERMINATED
Postpartum Pregnancy-Induced Hypertension; Postpartum Preeclampsia; Pregnancy-Induced Hypertension in Postpartum; Hypertensive Emergency
Columbia University
 2022-07-04 PHASE4
NCT05343806 COMPLETED
Threatened Preterm Labor
Assiut University
 2023-04-13
NCT04298034 ACTIVE_NOT_RECRUITING
Preeclampsia; Hypertension in Pregnancy
Medical College of Wisconsin
 2020-07-17 PHASE3
NCT06859554 COMPLETED
Acute Anal Fissure; Anal Pain; Anorectal Disorders; Sphincter Spasm
Hafiz Muhammad Hamza
 2025-03-17 PHASE4
NCT07448506 COMPLETED
High Blood Pressure (& [Essential Hypertension])
Laboratorios Richmond S.A.C.I.F.
 2024-07-09 PHASE3
NCT06265415 UNKNOWN
Severe Preeclampsia
Sohag University
 2024-03-30
NCT03949478 UNKNOWN
Epilepsy; Epilepsies, Partial
University of Calgary
 2021-02-01 PHASE2
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
NCT04404686 UNKNOWN
Obstetric Labor, Premature
Hadassah Medical Organization
 2020-10 PHASE2; PHASE3
NCT04186598 COMPLETED
Continuous Positive Airway Pressure; High Altitude Pulmonary Edema
CommonSpirit Health
 2020-01-20
NCT05686993 COMPLETED
Primary Aldosteronism; Endocrine Hypertension
Queen Mary University of London
 2023-04-24
NCT02531490 UNKNOWN
Hypertension, Pregnancy-Induced; Pre-Eclampsia
Maastricht University Medical Center
 2015-01-01 PHASE4
NCT05711810 COMPLETED
Severe Acute Respiratory Syndrome-related Coronavirus; Renal Dialysis; Vaccines; Myocarditis Allergic; Infection Viral
Yang I. Pachankis
 2023-01-02 PHASE4
NCT05520021 UNKNOWN
Preterm Labor Without Delivery; Pregnancy Preterm
Konya Meram State Hospital
 2022-09-01
NCT04790279 COMPLETED
Hypertension in Pregnancy
Prisma Health-Upstate
 2021-04-09 PHASE4
NCT05049616 COMPLETED
Hypertension in Pregnancy; Postpartum Preeclampsia
The University of Texas Health Science Center, Houston
 2021-10-18 PHASE4
NCT04392375 COMPLETED
Preeclampsia Severe
Ohio State University
 2020-06-09 PHASE4
NCT04887818 UNKNOWN
Fissure in Ano; Rectal Diseases; Rectal Bleed
University of Calgary
 2021-06 PHASE2; PHASE3
NCT05096728 Completed
Preeclampsia With Severe Features
Ohio State University
 2021-12-01 --
NCT04236258 COMPLETED
Hypertension in Pregnancy; Preeclampsia Severe; Gestational Hypertension; Postpartum Preeclampsia; Postpartum
Brigham and Women's Hospital
 2020-01-24 PHASE4
NCT04846621 UNKNOWN
Preterm Labor With Preterm Delivery
Ain Shams University
 2020-06-01 PHASE2
NCT04288219 UNKNOWN
High Altitude Pulmonary Edema; Non-Invasive Positive Pressure Ventilation; Hypoxia
Massachusetts General Hospital
 2020-03-01
NCT02885558 COMPLETED
Endothelium, Vascular
University of Southern Denmark
 2017-11-01
NCT03542552 COMPLETED
Placenta Previa
Assiut University
 2018-06-01 PHASE3
NCT04349124 TERMINATED
Hypertension in Pregnancy
Duke University
 2020-08-25 PHASE4
NCT02940548 TERMINATED
Hypertension
Jing Liu
 2016-12 PHASE4
NCT04438720 UNKNOWN
Therapeutic Equivalency
Cao Yu
 2020-06-25 PHASE1
NCT02499822 COMPLETED
Hypertension; High Blood Pressure Variability
Istituto Auxologico Italiano
 2015-10 PHASE4
NCT04392375 Completed
Preeclampsia Severe
Ohio State University
 2020-06-09 Phase 4
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
NCT02047019 WITHDRAWN
Hypertension
Bayer
 2017-12-01 PHASE3
NCT02641821 UNKNOWN
Hypertension
Peking University First Hospital
 2015-10 PHASE4
NCT02438371 TERMINATED
Preterm Labor
The University of Texas Health Science Center, Houston
 2015-05 PHASE4
NCT03695107 Unknown status
Chronic Kidney Diseases
The Third Xiangya Hospital of Central South University
 2019-10-02 --
NCT03129945 COMPLETED
Obstetric Labor, Premature
University of California, Irvine
 2017-01-17
NCT03506724 COMPLETED
Hypertension in Pregnancy; Preeclampsia
Icahn School of Medicine at Mount Sinai
 2017-09-11 PHASE4
NCT04435210 COMPLETED
Hypertension
Adebayo Joshua Adeniyi
 2018-08-13
NCT03449277 UNKNOWN
Postpartum Preeclampsia
Hossam Ahmed Abd Ellah
 2018-01-19 PHASE4
NCT02132533 COMPLETED
Preterm Labor
University of Texas Southwestern Medical Center
 2014-05-05 PHASE3
NCT02527109 COMPLETED
Chronic Anal Fissure
RDD Pharma Ltd
 2016-05 PHASE2; PHASE3
NCT03245307 UNKNOWN
Cytochrome P450 Interaction
Jiangsu HengRui Medicine Co., Ltd.
 2017-08-22 PHASE1
NCT02725736 UNKNOWN
Labor Preterm Multiple
Tel-Aviv Sourasky Medical Center
 2016-03 PHASE3
NCT02072291 UNKNOWN
Embryo Implantation
Hadassah Medical Organization
 2014-03 PHASE2
NCT03710395 UNKNOWN
Drug Transporter
Natalia Valadares de Moraes
 2015-12-14 PHASE4
NCT03100838 COMPLETED
Healthy Volunteers
Food and Drug Administration (FDA)
 2017-03-20 PHASE1
NCT03325348 UNKNOWN
Severe Pre-Eclampsia, Antepartum
Services Institute of Medical Sciences, Pakistan
 2017-02-23 PHASE2; PHASE3
NCT02563405 UNKNOWN
Hypertension
First Affiliated Hospital of Harbin Medical University
 2015-09 PHASE2; PHASE3
NCT02591004 COMPLETED
Preterm Labor; Cerebral Palsy
Kasr El Aini Hospital
 2015-12 PHASE2; PHASE3
NCT02513927 UNKNOWN
Hypertension
First Affiliated Hospital of Harbin Medical University
 2015-08 PHASE2; PHASE3
NCT01912677 COMPLETED
Hypertension in Pregnancy; Preeclampsia
Gynuity Health Projects
 2015-04 PHASE4
NCT03005496 COMPLETED
PreTerm Birth
Indonesia University
 2017-01 PHASE4
NCT02902354 WITHDRAWN
Tocolysis With Nifedipine
St. Louis University
 2016-09
NCT03040752 COMPLETED
Preterm Birth
Cairo University
 2015-01 PHASE4
NCT00223717 COMPLETED
Hypertension
Vanderbilt University
 2001-01 PHASE1
NCT02933593 WITHDRAWN
Hypertension
St. Louis University
 2016-08
NCT01157481 UNKNOWN
Diastolic Heart Failure
Demand Investigators
 2010-07
NCT02337881 UNKNOWN
Labor Preterm Requiring Hospitalization
Al Hayat National Hospital
 2015-01 PHASE1
NCT02463357 COMPLETED
Mountain Sickness
University of Colorado, Denver
 2015-08 PHASE4
NCT02902354 Withdrawn
Tocolysis With Nifedipine
St. Louis University
 2016-09 Not Applicable
NCT02413515 COMPLETED
Hypertension
Bayer
 2015-03-26 PHASE4
NCT03027674 COMPLETED
Raynaud Phenomenon Due to Trauma; Raynaud Disease; System; Sclerosis; Lupus Erythematosus, Systemic; Dermatomyositis; Ultrasound Therapy; Complications
Pontificia Universidad Catolica de Chile
 2016-08 EARLY_PHASE1
NCT02426177 UNKNOWN
Postnatal Hypertension
Dow University of Health Sciences
 2015-05 PHASE3
NCT01360034 UNKNOWN
Obstetric Labor, Premature
Saint Thomas Hospital, Panama
 2015-12 PHASE3
NCT02068404 UNKNOWN
Preterm Labor
Chantal Csajka
 2014-04 PHASE4
NCT03710395 Unknown status
Drug Transporter
Natalia Valadares de Moraes|Hospital das Clínicas de Ribeirão Preto|Universidade Estadual Paulista Júlio de Mesquita Filho
 2015-12-14 Phase 4
NCT02023047 TERMINATED
Anal Fissure
RDD Pharma Ltd
 2014-03 PHASE1; PHASE2
NCT02168309 COMPLETED
Severe Postpartum Hypertension
Cedars-Sinai Medical Center
 2014-06
NCT02357615 UNKNOWN
Essential Hypertension
Shanghai Shyndec Pharmaceutical Co., Ltd.
 2014-12 PHASE4
NCT02583633 COMPLETED
Managing Preterm Labor
Shiraz University of Medical Sciences
 2013-10 PHASE4
NCT01985594 UNKNOWN
Preterm Labor
nor zila hassan malek
 2013-11 PHASE2
NCT02031861 COMPLETED
Essential Hypertension
Shanghai Shyndec Pharmaceutical Co., Ltd.
 2014-02 PHASE4
NCT01788358 COMPLETED
Hypertension
Bayer
 2013-02-14 PHASE3
NCT01586286 WITHDRAWN
Levator Ani Syndrome
Vanderbilt University
 2012-07
NCT01796522 WITHDRAWN
Preterm Delivery.
Instituto de Investigacion Sanitaria La Fe
 2013-03 PHASE3
NCT01030081 COMPLETED
Hypertension
Shanghai Jiao Tong University School of Medicine
 2009-10 PHASE4
NCT00486824 COMPLETED
Obstetric Labor, Premature
Stanford University
 2007-04 PHASE1; PHASE2
NCT01351428 COMPLETED
Pre-Eclampsia; Pregnancy; Hypertension
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
 2010-12
NCT01830530 COMPLETED
Hypertension; High Altitude
Istituto Auxologico Italiano
 2012-05 PHASE4
NCT01314859 WITHDRAWN
Threatened Preterm Labor
Hospital Clinico Universitario de Santiago
 2011-07 PHASE3
NCT00620724 COMPLETED
Placenta Previa
University Hospital, Rouen
 2008-01 PHASE2
NCT01303783 COMPLETED
Hypertension, Essential
Bayer
 2011-04 PHASE2
NCT00641784 TERMINATED
Labor, Premature
MemorialCare
 2008-03 PHASE3
NCT01071122 COMPLETED
Hypertension
Bayer
 2010-01 PHASE4
NCT01348880 COMPLETED
Erectile Dysfunction
Bayer
 2011-05 PHASE1
NCT00599898 COMPLETED
Labor, Premature
Raed Salim
 2008-01 PHASE4
NCT00605072 COMPLETED
Cognitive Impairment; Hypertension; Aging
University of Southern California
 2008-01 PHASE2
NCT01294215 COMPLETED
Hypertension
Bayer
 2011-02 PHASE3
NCT01355367 COMPLETED
Hypertension
Bayer
 2011-01 PHASE3
NCT01350609 COMPLETED
Hypertension, Essential
Bayer
 2011-04 PHASE1
NCT01435161 COMPLETED
Atrial Fibrillation
The Second Affiliated Hospital of Chongqing Medical University
 2007-05 PHASE4
NCT01287260 COMPLETED
Hypertension
Bayer
 2011-01 PHASE3
NCT00993109 COMPLETED
Hypertension
Bayer
 2010-02 PHASE4
NCT01167153 COMPLETED
Hypertension
Novartis
 2010-05 PHASE4
NCT01227603 COMPLETED
Hypertension, Essential
Bayer
 2010-11 PHASE1
NCT00972907 COMPLETED
Chronic Anal Fissure
RDD Pharma Ltd
 2009-12 PHASE1; PHASE2
NCT01021501 UNKNOWN
Hypertension on Chronic Maintenance Hemodialysis
Guangzhou First People's Hospital
 2009-12 PHASE4
NCT00713739 UNKNOWN
Kidney Stones
United States Naval Medical Center, San Diego
 2008-01 PHASE3
NCT00712738 COMPLETED
Thalassemia; Iron Overload; Hemochromatosis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2008-06-20 PHASE1
NCT01429545 COMPLETED
Preterm Labour
Tawam Hospital
 2007-04 PHASE2
NCT03136666 COMPLETED
Clinical Pharmacology
Bayer
 2010-04-19 PHASE1
NCT01215708 UNKNOWN
Renal Calculi
University of Sao Paulo General Hospital
 2006-08 PHASE3
NCT00593463 COMPLETED
Drug Dependence
University of Arkansas
 2006-09 PHASE1
NCT00306462 TERMINATED
Premature Birth; Premature Labor
University of Cincinnati
 2006-03
NCT01010048 UNKNOWN
Urinary Calculus
Chongqing Medical University
 2009-10 PHASE4
NCT00661895 COMPLETED
Hypertension
Creighton University
 2005-08 PHASE4
NCT00817037 COMPLETED
Chronic Kidney Disease; Proteinuria; Blood Pressure
University of Edinburgh
 2007-07-14 PHASE2
NCT00750113 COMPLETED
Hypertension
Bayer
 2007-10 PHASE4
NCT01346657 COMPLETED
Healthy Volunteers
Taipei Medical University WanFang Hospital
 2009-07 PHASE4
NCT00811057 COMPLETED
Preterm Labor
University of Mississippi Medical Center
 2004-06
NCT00884442 COMPLETED
Bioavailability, Therapeutical Indication Not Studied
SocraTec R&D GmbH
 2009-04 PHASE1
NCT00810732 COMPLETED
Chronic Kidney Disease
Pfizer
 2007-05-09 PHASE2
NCT02071589 COMPLETED
Bioequivalence
Reig Jofre Group
 2009-01 PHASE1
NCT00137501 TERMINATED
Labor, Premature
American University of Beirut Medical Center
 2003-05 PHASE3
NCT00768560 COMPLETED
Hypertension
Bayer
 2008-01 PHASE2
NCT00722215 COMPLETED
Chronic Kidney Disease; Proteinuria
University of Edinburgh
 2006-05 PHASE1
NCT00496184 COMPLETED
Vulvar Diseases; Vulvar Pain; Vestibulitis; Vestibulodynia; Vulvodynia
Western Galilee Hospital-Nahariya
 2006-04 PHASE3
NCT00325936 COMPLETED
Hypertension; Metabolic Syndrome X
Boryung Pharmaceutical Co., Ltd
 2005-07 PHASE4
NCT00185952 COMPLETED
Obstetric Labor, Premature; Venous Thrombosis
Stanford University
 2001-11
NCT00280462 COMPLETED
Ocular Physiology; Regional Blood Flow
Medical University of Vienna
 2005-08
NCT00865891 COMPLETED
Healthy
Actavis Inc.
 2005-07 PHASE1
NCT00185900 COMPLETED
Obstetric Labor, Premature
Stanford University
 1999-04
NCT00864617 COMPLETED
Healthy
Actavis Inc.
 2005-05 PHASE1
NCT01518855 COMPLETED
Hypertension
Bayer
 2004-03 PHASE4
NCT00194974 WITHDRAWN
Pregnancy Toxemia; Hypertension; Proteinuria
Weill Medical College of Cornell University
 2004-07 PHASE1; PHASE2
NCT00004266 COMPLETED
Diabetic Nephropathy
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 1993-08 PHASE3
NCT00519870 COMPLETED
Pulmonary Hypertension
Baskent University
 2005-01 PHASE3
NCT00525486 TERMINATED
Preterm Labor
The Baruch Padeh Medical Center, Poriya
 2007-12
NCT00244530 COMPLETED
Kidney Failure, Chronic; Coronary Artery Disease
University of Oslo School of Pharmacy
 2001-06 PHASE4
NCT00000530 COMPLETED
Cardiovascular Diseases; Heart Diseases; Raynaud's Disease; Vascular Diseases
National Heart, Lung, and Blood Institute (NHLBI)
 1992-09 PHASE3
NCT00173667 UNKNOWN
Hypertension
National Taiwan University Hospital
 PHASE4
NCT00000478 COMPLETED
Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Ischemia
National Heart, Lung, and Blood Institute (NHLBI)
 1990-11 PHASE3
NCT00391339 UNKNOWN
Tocolysis
Weleda AG
 2006-11 PHASE2; PHASE3
NCT00000102 COMPLETED
Congenital Adrenal Hyperplasia
National Center for Research Resources (NCRR)
 PHASE1; PHASE2
NCT00816205 COMPLETED
Anal Resting Pressure
RDD Pharma Ltd
 PHASE1; PHASE2
NCT00672113 COMPLETED
Hypertension
Bayer
 2003-12 PHASE4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nifedipine selectively binds to L-type voltage-gated calcium channels in vascular smooth muscle cells, effectively blocking the transmembrane influx of calcium ions during cellular depolarization. This intracellular calcium restriction inhibits excitation-contraction coupling to promote peripheral vasodilation, providing the functional basis for controlling elevated blood pressure in clinical conditions such as severe preeclampsia and hypertension.

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.