MedPath

Nifedipine

Generic Name
Nifedipine
Brand Names
Adalat, Afeditab CR, Nifediac, Nifedical, Procardia
Drug Type
Small Molecule
Chemical Formula
C17H18N2O6
CAS Number
21829-25-4
Unique Ingredient Identifier
I9ZF7L6G2L
Background

Nifedipine, or BAY a 1040, is a first generation dihydropyridine L-type calcium channel blocker, similar to nicardipine. Nifedipine was developed by Bayer and first described in the literature, along with other dihydropyridines, in 1972. Since nifedipine's development, second and third generation dihydropyridines have been developed with slower onsets and longer durations of action. The most popular of the third generation dihydropyridines is amlodipine.

Nifedipine was granted FDA approval on 31 December 1981.

Indication

Nifedipine capsules are indicated to treat vasospastic angina and chronic stable angina. Extended release tablets are indicated to treat vasospastic angina, chronic stable angina, and hypertension.

Associated Conditions
Achalasia, Chronic Stable Angina Pectoris, Fissure;Anal, Hypertension, Hypertensive Emergency, Premature Labour, Proctalgia, Pulmonary Edemas, Pulmonary Hypertension (PH), Raynaud's Phenomenon, Ureteral Calculus, Vasospastic Angina

Nifedipine Versus Indomethacin in the Treatment of Preterm Labour

Phase 3
Conditions
Obstetric Labor, Premature
Interventions
First Posted Date
2011-05-25
Last Posted Date
2015-01-05
Lead Sponsor
Saint Thomas Hospital, Panama
Target Recruit Count
216
Registration Number
NCT01360034
Locations
🇵🇦

Saint Thomas Hospital, Panama, Panama

High Dose BAYA1040 CR: a Long Term Extension Study

Phase 3
Completed
Conditions
Hypertension
Interventions
First Posted Date
2011-05-18
Last Posted Date
2014-01-29
Lead Sponsor
Bayer
Target Recruit Count
120
Registration Number
NCT01355367

Pivotal Bioequivalence FDC Nifedipine / Candesartan vs. Loose Combination of Single Components, Fed

Phase 1
Completed
Conditions
Hypertension, Essential
Interventions
First Posted Date
2011-05-10
Last Posted Date
2015-12-10
Lead Sponsor
Bayer
Target Recruit Count
49
Registration Number
NCT01350609

Goal-Directed Therapy in Pregnant Women at High Risk of Developing Preeclampsia

Not Applicable
Completed
Conditions
Pre-Eclampsia
Pregnancy
Hypertension
Interventions
First Posted Date
2011-05-10
Last Posted Date
2012-11-12
Lead Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Target Recruit Count
20
Registration Number
NCT01351428
Locations
🇨🇦

Mount Sinai Hospital, Toronto, Ontario, Canada

Nifedipine Treatment in Preterm Labor

Phase 3
Withdrawn
Conditions
Threatened Preterm Labor
Interventions
First Posted Date
2011-03-15
Last Posted Date
2014-07-29
Lead Sponsor
Hospital Clinico Universitario de Santiago
Registration Number
NCT01314859

High Dose BAYA1040_Nifedipine: a Long Term Combination Study

Phase 3
Completed
Conditions
Hypertension
Interventions
First Posted Date
2011-02-11
Last Posted Date
2014-06-23
Lead Sponsor
Bayer
Target Recruit Count
72
Registration Number
NCT01294215

High Dose BAYA1040_Nifedipine: a Dose-comparative Study

Phase 3
Completed
Conditions
Hypertension
Interventions
First Posted Date
2011-02-01
Last Posted Date
2014-01-29
Lead Sponsor
Bayer
Target Recruit Count
352
Registration Number
NCT01287260

Single Dose Bioequivalence Study Comparing Nifedipine/Candesartan FDC (Fixed Dose Combination) With Loose Combination of Nifedipine GITS (Gastro-intestinal Therapeutic System) Plus Candesartan and Single Components Under Fasting Conditions

Phase 1
Completed
Conditions
Hypertension, Essential
Interventions
First Posted Date
2010-10-25
Last Posted Date
2015-12-10
Lead Sponsor
Bayer
Target Recruit Count
49
Registration Number
NCT01227603

Effectiveness of Valsartan/Amlodipine (EXforge®) and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients

Phase 4
Completed
Conditions
Hypertension
Interventions
Drug: Valsartan/Amlodipine
First Posted Date
2010-07-22
Last Posted Date
2012-06-01
Lead Sponsor
Novartis
Target Recruit Count
564
Registration Number
NCT01167153
Locations
🇨🇳

Novartis Pharmaceuticals, Beijing, China

© Copyright 2025. All Rights Reserved by MedPath