Clinical Trials

Multiple clinical trials evaluate the therapeutic utility of nitrendipine, primarily targeting vascular disorders such as hypertension, isolated systolic hypertension, and chronic kidney disease. Spanning Phase 2, Phase 3, and Phase 4 trials alongside non-interventional or unspecified studies, these initiatives are sponsored by pharmaceutical entities and academic medical centers, including Daiichi Sankyo Europe, Merck KGaA, KU Leuven, West China Hospital, and Shanghai Jiao Tong University School of Medicine. Recruitment statuses across these records vary, encompassing completed studies as well as trials that were terminated, withdrawn, or remain of unknown status.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04931108 UNKNOWN
Hypertension
Shanghai Jiao Tong University School of Medicine
 2021-09-27 PHASE4
NCT04371874 COMPLETED
Hypertension
First Affiliated Hospital Xi'an Jiaotong University
 2014-01
NCT02217852 UNKNOWN
Hypertension
West China Hospital
 2014-08 PHASE4
NCT00892892 WITHDRAWN
Chronic Kidney Disease; Hypertension
University of Erlangen-Nürnberg Medical School
 2009-11 PHASE4
NCT00751829 COMPLETED
Isolated Systolic Hypertension
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
 2003-07 PHASE3
NCT02088450 TERMINATED
Isolated Systolic Hypertension
KU Leuven
 1990-02 PHASE2

(data from https://clinicaltrials.gov, updated on 2023-04-14)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nitrendipine selectively binds to dihydropyridine-sensitive L-type calcium channels with an IC50 of 95 nM, preventing transmembrane calcium ion influx into vascular smooth muscle cells. This blockade reduces intracellular calcium concentrations and inhibits vascular smooth muscle contraction, leading to arterial vasodilation that effectively lowers blood pressure in clinical conditions such as hypertension and isolated systolic 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.