CLINICAL TRIALS PROFILE FOR NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE

All Clinical Trials for NICARDIPINE HYDROCHLORIDE IN 0.86% 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.
NCT00226096 ↗	Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage	Completed	National Health and Medical Research Council, Australia	N/A	2005-11-01	The purpose of the study is to determine whether lowering high blood pressure levels after the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce the chances of a person dying or surviving with a long term disability. The study will be undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000 patients.

Clinical Trial Conditions for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE

Condition Name

Condition Name for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE
Intervention	Trials
Hypertension	10
Subarachnoid Hemorrhage	4
Intracerebral Hemorrhage	3
Coronary Artery Disease	2

Condition MeSH

Condition MeSH for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE
Intervention	Trials
Hypertension	13
Hemorrhage	9
Cerebral Hemorrhage	6
Subarachnoid Hemorrhage	6

Clinical Trial Locations for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE

Trials by Country

Trials by Country for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE
Location	Trials
United States	93
China	31
Japan	5
Australia	5
Korea, Republic of	5

Trials by US State

Trials by US State for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE
Location	Trials
Illinois	7
New York	6
Ohio	6
Pennsylvania	5
Massachusetts	4

Clinical Trial Progress for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE

Clinical Trial Phase

Clinical Trial Phase for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE
Clinical Trial Phase	Trials
PHASE4	3
Phase 4	14
Phase 3	11

Clinical Trial Status

Clinical Trial Status for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE
Clinical Trial Phase	Trials
COMPLETED	24
Not yet recruiting	10
RECRUITING	9

Clinical Trial Sponsors for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE

Sponsor Name

Sponsor Name for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE
Sponsor	Trials
Yonsei University	4
The Medicines Company	4
National Institute of Neurological Disorders and Stroke (NINDS)	3

Sponsor Type

Sponsor Type for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE
Sponsor	Trials
Other	154
Industry	12
NIH	3

Nicardipine Hydrochloride in 0.86% Sodium Chloride Clinical Trials Update, Market Analysis, and Forecast

Last updated: May 24, 2026

Nicardipine hydrochloride in 0.86% sodium chloride is a single product with a specific drug-in-diluent presentation. A complete clinical-trials update and market forecast requires a uniquely identifiable FDA product record (NDC/brand name), confirmed regulatory status, and an evidence-backed patent and competitive landscape. Without those identifiers, an accurate projection and trial-status timeline cannot be produced.

What is nicardipine hydrochloride in 0.86% sodium chloride, and how is it used clinically?

Answer: It is nicardipine, a dihydropyridine calcium-channel blocker, formulated for intravenous use in an 0.86% sodium chloride diluent system.

Mechanism of action and therapeutic positioning

Nicardipine lowers blood pressure by blocking L-type calcium channels in vascular smooth muscle. Clinically, it is used for controlled reduction of blood pressure in settings where titratability matters, including perioperative and hypertensive emergency contexts.

Dosage form and administration constraints

Because the requested topic is a fixed drug-in-diluent presentation, substitution with a differently diluted nicardipine product can change:

• infusion stability profile
• dosing volume and line compatibility
• regulatory labeling references that guide substitution at pharmacy level

What clinical trials exist for nicardipine hydrochloride in 0.86% sodium chloride?

Answer: A verified clinical-trials update cannot be provided without a uniquely mapped product identity (brand/NDC) tied to ClinicalTrials.gov records and sponsor/manufacturer listings.

Trial registry mapping requirements

A credible update requires that trial records explicitly match:

• nicardipine hydrochloride IV formulation
• the specific diluent concentration system (0.86% sodium chloride)
• the same route and dose regimen
• sponsor and study endpoints

Without a product-to-registry mapping, any summary risks mixing nicardipine in other diluents (for example, other sodium chloride concentrations or dextrose solutions) with the requested presentation.

Endpoints that drive regulatory decisions

For intravenous antihypertensives, key endpoints typically include:

• time to achieve target blood pressure
• proportion achieving control within a prespecified window
• safety signals (hypotension, tachycardia, adverse infusion reactions)
• infusion-related tolerability

How many patients are enrolled, and what are the key phase-stage readouts?

Answer: Not available in a way that supports an accurate market or development forecast.

How to interpret development stage for market timing

A market projection depends on phase and expected timing of:

• primary endpoint completion
• data submission
• label update or approval milestones
• launch readiness and supply chain stability

Without confirmed phase-stage linkage to the exact diluent product, any enrollment and readout count would be unreliable.

When does nicardipine hydrochloride in 0.86% sodium chloride lose exclusivity?

Answer: Exclusivity timelines cannot be determined without validated FDA approval identity and Orange Book linkages for this exact presentation.

Regulatory exclusivity types that typically matter

For a forecast, the critical items are:

• 5-year new chemical entity (if applicable)
• 3-year new clinical investigation exclusivity
• patent term adjustments and restorations
• exclusivity listed for the specific NDC and dosage form

These cannot be computed without product-specific identifiers and Orange Book listings.

What patents protect nicardipine hydrochloride in 0.86% sodium chloride?

Answer: A complete, actionable patent estate cannot be produced without confirmed patent listings tied to the product’s FDA reference NDC and formulation.

What a product-specific patent map must include

A robust map requires:

• composition-of-matter
• formulation and stability/diluent patents
• method-of-use (indication and dosing regimen)
• manufacturing process patents
• any device or container-closure system limitations affecting use

Without product-linked patent numbers and assignees, the analysis cannot be completed.

What is the Orange Book status of nicardipine hydrochloride in 0.86% sodium chloride?

Answer: Not available to support a correct Orange Book status statement.

What “status” must include for decision-making

A correct status needs:

• listed patents by expiration date
• patent type (drug substance, drug product, method)
• whether patents cover this exact NDC strength and dosage form
• whether the record indicates exclusivity expiration

Which companies control supply, and what is the competitive landscape?

Answer: A competitive market view cannot be accurately scoped without the drug’s branded name, label holder, and NDC set.

Competitive dynamics that change projections

Market outcomes depend on:

• number of listed competitors and authorized generics
• substitution at hospital formularies
• procurement contracts and distribution agreements
• supply stability and manufacturing capacity constraints

None can be quantified without product identifiers.

What market size and revenue exposure does this formulation face?

Answer: Not possible to quantify without verified regulatory status and product-level commercial data.

What must be pinned down for forecasting

A defensible projection requires:

• US (and other geography) sales by NDC/strength
• trend drivers (hospital volume, ICU utilization, formulary access)
• price and reimbursement dynamics
• competitive erosion timing

Without product mapping, any revenue estimate would be fabricated rather than evidenced.

How would generic or biosimilar entry risks affect pricing?

Answer: Entry-risk assessment cannot be completed for this exact presentation without:

• patent/Orange Book status for the NDC
• history of Paragraph IV filings (if any)
• settlement/licensing outcomes affecting launch timing

What drives generic timing for IV calcium-channel blocker formulations

IV injectables often see entry governed by:

• product-specific formulation patents
• container-closure and stability patents
• labeling and method-of-use limitations
• manufacturing process requirements for sterility assurance

No validated record is available to support a launch scenario.

How does nicardipine hydrochloride in 0.86% sodium chloride compare with other nicardipine IV formulations?

Answer: A comparison cannot be completed to a decision-grade standard without knowing which competing products are relevant (same strength, same route, different diluent concentration, different concentrations).

Key comparison dimensions for hospitals and payers

Comparisons must cover:

• diluent concentration and infusion compatibility
• stability and shelf-life
• labeling indications and dosing instructions
• NDC availability and procurement terms
• any regulatory constraints on substitution

What does the evidence suggest about safety and tolerability in this formulation?

Answer: A safety summary cannot be issued without a clinical evidence set matched to the exact diluent product.

Safety outcomes that matter for IV infusion

Typical concerns include:

• hypotension and reflex tachycardia
• flushing, headache
• infusion site reactions
• laboratory abnormalities where reported in labeling

A diluent-matched evidence set is required to avoid incorrect attribution.

Key Takeaways

• A clinical-trials update and market projection for “nicardipine hydrochloride in 0.86% sodium chloride” cannot be completed to an actionable standard without verified product identity mapping to FDA/ClinicalTrials.gov and commercial datasets.
• Any exclusivity, patent, Orange Book status, and competitive-entry analysis depends on confirmed NDC/brand label linkage for this exact presentation.

FAQs

1. What ClinicalTrials.gov studies match nicardipine hydrochloride IV in 0.86% sodium chloride rather than other diluents?
2. Is nicardipine hydrochloride in 0.86% sodium chloride approved for the same indications as other IV nicardipine strengths and diluent concentrations?
3. How many US patents are listed for the exact NDC corresponding to this nicardipine diluent system?
4. Are there Paragraph IV challenges tied to this specific nicardipine hydrochloride formulation and strength?
5. What NDC-level data best predicts hospital procurement and pricing changes for IV nicardipine products?