Last Updated: August 12, 2026

CLINICAL TRIALS PROFILE FOR NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE


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All Clinical Trials for NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00007592 ↗ Hypertension Screening and Treatment Program Completed US Department of Veterans Affairs 1989-06-01 Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
NCT00007592 ↗ Hypertension Screening and Treatment Program Completed VA Office of Research and Development 1989-06-01 Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
NCT00093925 ↗ Clevidipine in the Postoperative Treatment of Hypertension (ECLIPSE-NIC) Completed The Medicines Company Phase 3 2004-05-01 The purpose of this study is to establish the safety of clevidipine in the treatment of postoperative hypertension. Approximately 250-500 patients with postoperative hypertension after undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB) or minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve replacement/repair procedures were anticipated to be randomly assigned to one of two treatment groups: clevidipine or nicardipine.
NCT00137501 ↗ Two Dose Regimens of Nifedipine for the Management of Preterm Labor Terminated American University of Beirut Medical Center Phase 3 2003-05-01 Preterm birth is one of the most important causes of perinatal morbidity and mortality worldwide. Prevention and treatment of preterm labor is important, not as an end in itself, but as a means of reducing adverse events for the neonate. A wide range of tocolytics, drugs used to suppress uterine contractions, have been tried. Magnesium sulfate (MgSO4) is the most widely used tocolytic at the American University of Beirut Medical Center despite the fact that an effective tocolytic role of MgSO4 has never been established. Moreover, the currently available data are suggestive of deleterious fetal effects of MgSO4 in the setting of preterm labor to the extent that some authorities are recommending abandoning it for routine use as a tocolytic therapy. Calcium channel blockers have the ability to inhibit contractility in smooth muscle cells. Consequently, nifedipine has emerged as an effective and rather safe alternative tocolytic agent for the management of preterm labor after several studies have shown that the use of nifedipine in comparison with other tocolytics is associated with a more frequent successful prolongation of pregnancy, resulting in significantly fewer admissions of newborns to the neonatal intensive care unit, and is associated with a lower incidence of respiratory distress syndrome. The unequivocal impact of this method of tocolysis on short term postponement of delivery and the opportunity that this provides for affecting in-utero transfer and steroid administration has prompted many investigators to recommend focusing future trials on testing different dose regimens of nifedipine. To the best of the investigators' knowledge, no study comparing two different dose regimens of nifedipine has been previously published in the literature. The objective of their study is to compare the effectiveness of a high versus a low dose regimen in a total of 200 patients admitted with the diagnosis of preterm labor between 24 and 34 weeks of gestation. In addition, the investigators' study will try to assess the safety profile of the 2 dose regimens on the mother and the neonate by assessing a selected number of outcome variables. The data generated will be used to change their protocol for managing patients presenting with threatened preterm delivery and will fill the existing gap regarding the most effective and safest dose regimen of nifedipine in such patients.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

Condition Name

Condition Name for NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Intervention Trials
Hypertension 10
Subarachnoid Hemorrhage 4
Intracerebral Hemorrhage 3
Coronary Artery Disease 2
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Condition MeSH

Condition MeSH for NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Intervention Trials
Hypertension 13
Hemorrhage 9
Cerebral Hemorrhage 6
Subarachnoid Hemorrhage 6
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Clinical Trial Locations for NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

Trials by Country

Trials by Country for NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Location Trials
United States 93
China 31
Australia 5
Korea, Republic of 5
Japan 5
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Trials by US State

Trials by US State for NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Location Trials
Illinois 7
New York 6
Ohio 6
Pennsylvania 5
North Carolina 4
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Clinical Trial Progress for NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

Clinical Trial Phase

Clinical Trial Phase for NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Clinical Trial Phase Trials
PHASE4 3
Phase 4 14
Phase 3 11
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Clinical Trial Status

Clinical Trial Status for NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Clinical Trial Phase Trials
Completed 24
Not yet recruiting 10
Recruiting 9
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Clinical Trial Sponsors for NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

Sponsor Name

Sponsor Name for NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Sponsor Trials
Yonsei University 4
The Medicines Company 4
National Institute of Neurological Disorders and Stroke (NINDS) 3
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Sponsor Type

Sponsor Type for NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Sponsor Trials
Other 154
Industry 12
NIH 3
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Last updated: July 27, 2026

Nicardipine Hydrochloride in 0.9% Sodium Chloride clinical trials update, market analysis and projection

Executive summary

Nicardipine hydrochloride in 0.9% sodium chloride (IV infusion; concentrated formulation diluted in normal saline) is used for blood pressure control in acute settings, most often for perioperative hypertension and hypertensive emergencies requiring titratable IV therapy. Public clinical-trials and commercial-material review for this exact “nicardipine HCl in 0.9% sodium chloride” presentation is not available in the provided dataset, and without verified product-specific trial records, Orange Book listing status, or current buyer-side market disclosures, a complete and accurate, data-backed update and forward market projection cannot be produced.

Which clinical trials exist for nicardipine hydrochloride in 0.9% sodium chloride (IV) and what are their endpoints?

No product-specific clinical-trial registry extraction is available in the provided information to enumerate active or completed studies using this exact diluted IV presentation, dosing regimen, infusion duration, comparator arms, or primary endpoints.

What indications are being studied for IV nicardipine with normal saline

No indication-by-indication trial mapping is available in the provided information.

Are there ongoing trials in hypertensive emergency, perioperative settings, or stroke-related hypertension

No ongoing-trial status by registry and site geography is available in the provided information.

What is the market size and current sales of nicardipine hydrochloride IV infusion diluted in 0.9% sodium chloride?

No verified sales, unit volumes, pricing, or channel distribution data for this exact presentation is available in the provided information.

How does procurement typically work for IV nicardipine in normal saline

No hospital formulary, tender pricing, or payer policy data is available in the provided information.

Which countries drive volume for IV nicardipine infusion

No geography-specific market split is available in the provided information.

How fast is IV nicardipine demand growing, and what are the key demand drivers?

No demand driver evidence tied to this exact presentation is available in the provided information.

What are the utilization drivers in emergency medicine and perioperative care

No utilization pattern data is available in the provided information.

What guideline changes affect nicardipine use

No guideline publication linkage to this exact presentation is available in the provided information.

When does nicardipine hydrochloride IV lose exclusivity, and what patent issues affect competition?

No patent- or exclusivity-structure for the exact “nicardipine hydrochloride in 0.9% sodium chloride” presentation is available in the provided information.

What is the Orange Book status of this nicardipine IV presentation

No Orange Book listing details are available in the provided information.

Are there Paragraph IV filings for IV nicardipine

No Paragraph IV filing information is available in the provided information.

What generic entry risks exist for nicardipine hydrochloride in 0.9% sodium chloride, including compounding and 505(b)(2) pathways?

No verified generic launch pipeline, regulatory pathway history, or product-specific barriers are available in the provided information.

How do manufacturing and container-closure requirements affect generic approval

No formulation/container-closure evidence is available in the provided information.

What substitution risks exist at the hospital level

No formulary interchangeability or therapeutic-equivalency outcomes are available in the provided information.

How does this product compare with other IV nicardipine products (ethanol-free vs diluted preparations) and with alternative IV antihypertensives?

No product-composition and comparative performance data is available in the provided information for this exact presentation.

Comparison with clevidipine, labetalol, nicardipine other salt forms, and nitroprusside

No head-to-head evidence or utilization comparison tied to this presentation is available in the provided information.

Which dosing and titration characteristics influence uptake

No dosing protocol or pharmacodynamic performance data is available in the provided information.

What regulatory status does nicardipine hydrochloride in 0.9% sodium chloride have at FDA and globally?

No regulatory dossier, approval history, labeling details, or global marketing authorizations are available in the provided information.

FDA pathway and label elements

No FDA pathway and label mapping is available in the provided information.

Global approvals and tender restrictions

No EMA, UK, or other agency status is available in the provided information.

Clinical development timeline: what has changed recently for nicardipine IV infusions?

No “recent changes” dataset is available in the provided information to build a verified timeline of approvals, safety signals, label updates, or study completions.

Safety updates and post-marketing requirements

No post-marketing surveillance outcomes are available in the provided information.

Any changes in dosing limits, infusion rates, or contraindications

No label-change evidence is available in the provided information.

Market projection scenarios for nicardipine hydrochloride IV in 0.9% sodium chloride through 2030

No baseline market, competitive set, launch schedule, exclusivity/entry calendar, or regulatory risk factors are available in the provided information to support a complete, accurate projection.

Base case, downside, and upside assumptions

No assumption set is available in the provided information.

Unit and revenue projection structure

No unit-to-revenue model inputs (pricing, dosage strength mix, vial/bag sizes, purchasing cadence) are available in the provided information.

Key takeaways

  • Product-specific clinical trial inventory, endpoints, regulatory status, exclusivity, and market metrics for “nicardipine hydrochloride in 0.9% sodium chloride” are not available in the provided information, so a complete, accurate clinical update and market forecast cannot be produced.
  • Any market projection would require verified inputs on current sales/units, pricing, utilization drivers, competitive launches, and regulatory/exclusivity calendars tied to the exact presentation.

FAQs

  1. Are there active phase 3 or phase 4 trials of IV nicardipine diluted in normal saline registered in major registries?
  2. Does FDA labeling for IV nicardipine include dosing titration guidance that differs by dilution vehicle?
  3. Which hospitals or health systems restrict substitution for IV nicardipine due to formulation or container-closure requirements?
  4. What alternative IV agents are most frequently used when nicardipine is unavailable, and how does that affect demand?
  5. Do any generic or biosimilar pathways create near-term competition risk for IV nicardipine products?

References

No sources were provided in the prompt, and no citable materials are available from the provided information.

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