CLINICAL TRIALS PROFILE FOR NICARDIPINE HYDROCHLORIDE

All Clinical Trials for nicardipine hydrochloride

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.
NCT00226096 ↗	Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage	Completed	The George Institute	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

Condition Name

Condition Name for nicardipine hydrochloride
Intervention	Trials
Hypertension	10
Subarachnoid Hemorrhage	4
Intracerebral Hemorrhage	3
Coronary Artery Disease	2

Condition MeSH

Condition MeSH for nicardipine hydrochloride
Intervention	Trials
Hypertension	13
Hemorrhage	9
Cerebral Hemorrhage	6
Subarachnoid Hemorrhage	6

Clinical Trial Locations for nicardipine hydrochloride

Trials by Country

Trials by Country for nicardipine hydrochloride
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
Location	Trials
Illinois	7
Ohio	6
New York	6
Pennsylvania	5
Tennessee	4

Clinical Trial Progress for nicardipine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for nicardipine hydrochloride
Clinical Trial Phase	Trials
PHASE4	3
Phase 4	14
Phase 3	11

Clinical Trial Status

Clinical Trial Status for nicardipine hydrochloride
Clinical Trial Phase	Trials
Completed	24
Not yet recruiting	10
Recruiting	9

Clinical Trial Sponsors for nicardipine hydrochloride

Sponsor Name

Sponsor Name for nicardipine hydrochloride
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
Sponsor	Trials
Other	154
Industry	12
NIH	3

Nicardipine hydrochloride Market Analysis and Financial Projection

Last updated: April 27, 2026

Nicardipine Hydrochloride: Clinical Trials Update, Market Analysis, and 5-Year Projection

What is nicardipine hydrochloride and how is it positioned?

Nicardipine hydrochloride is a calcium channel blocker (dihydropyridine class) used for hypertension and related cardiovascular indications. It is marketed in multiple jurisdictions in oral and injectable forms, including sustained-release or immediate-release oral products and intravenous formulations used in acute settings (e.g., perioperative blood pressure control and hypertensive emergencies depending on country label).

Key commercial implication: nicardipine competes in a crowded antihypertensive landscape where dosing convenience (oral vs IV), time-to-effect, and payer formulary placement drive uptake more than clinical novelty for this mature molecule. This creates a market profile that is sensitive to generic penetration, hospital formulary cycles, and regional regulatory access.

---

What does the current clinical trials landscape show?

A complete “clinical trials update” requires a live query of public registries (ClinicalTrials.gov, EU CTR, WHO ICTRP) with current statuses. The provided prompt does not include any registry extracts, trial IDs, or dates, so a precise, up-to-date trial table cannot be constructed without risking inaccuracies.

Given that constraint, the only safe clinical-trials deliverable is a high-level interpretation of the development reality for a long-standing antihypertensive without introducing incorrect “current” listings:

• Nicardipine development in mature geographies typically shifts to line extensions (new formulations, adjusted release profiles), bioequivalence for generics, and regional bridging studies.
• Large, pivotal new trials are less common than for newer classes, unless targeting a specific new use such as neuroprotection, vasospasm, or perioperative use in a defined surgical population.

Result: a rigorous, trial-level update is not provided because it would require fresh, verifiable registry data.

---

How big is the nicardipine hydrochloride market and what is the demand engine?

A market analysis should separate:

1. Therapy demand (hypertension and acute BP control prevalence and guideline-driven use)
2. Route mix (oral chronic vs IV acute or perioperative)
3. Share dynamics (generic entry and branded-to-generic erosion)
4. Reimbursement and tender cycles (hospital purchasing and formulary controls)

Market drivers that typically move nicardipine volumes

• Hypertension prevalence and treatment intensity across established patient pools
• Hospital use for acute BP management where IV dihydropyridines remain in formularies in certain countries
• Generic competition: as patents expire, price pressure dominates value growth while unit volumes may remain stable or decline modestly depending on prescribing habits

Market headwinds

• Therapeutic class saturation with multiple generics and close substitutes (other calcium channel blockers and alternatives)
• IV BP management protocols that favor other options in some hospital systems (agent availability, nursing protocols, monitoring requirements)

Result: a quantified market size, category share, and CAGR cannot be produced from the prompt content without injecting unverified numbers.

---

What is the 5-year projection for nicardipine hydrochloride?

A credible 5-year projection needs quantified baselines (current revenue/unit volumes, country split, generic penetration timing, and price erosion curves). The prompt provides no baseline dataset, no current market figure, and no region segmentation.

A projection built without those baselines would require assumptions that would not be factual.

Result: no numeric 5-year projection is provided.

---

Actionable business implications (non-numeric but decision-relevant)

Where does value creation still exist for a mature molecule?

• Formulation differentiation within generics (dose strengths, release profile, stability, IV line compatibility)
• Manufacturing reliability and regulatory continuity for hospital supply chains
• Tender strategy: targeting hospital systems where nicardipine is already in standard protocols, then expanding line share via pharmacokinetic/pharmacodynamic fit and switching logistics

What risk controls matter most for portfolio planning?

• Supply chain continuity: injection products are sensitive to production disruptions
• Regulatory and label consistency across jurisdictions, especially IV indications
• Payer and hospital formulary dynamics: forecasting requires tracking tender cycles and contract renewals, not only trial pipelines

---

Key Takeaways

• Nicardipine hydrochloride is a mature, generic-dominated calcium channel blocker where clinical-trial breakthroughs are typically less frequent than formulation and regulatory updates.
• A trial-level “current update” and a quantified market projection cannot be completed without live, verifiable registry and market baseline data.
• Commercial outcomes are driven primarily by route mix, generic pricing dynamics, hospital tender cycles, and supply continuity rather than new clinical differentiation.

---

FAQs

1) Are there likely any new pivotal trials for nicardipine hydrochloride?

Most ongoing activity for mature antihypertensives tends to cluster around generics, bioequivalence, and regional bridging rather than new pivotal efficacy trials.

2) Does nicardipine’s market depend more on oral or IV use?

Market value usually depends on route mix by region. Hospital IV use can matter disproportionately where perioperative or acute BP protocols include it, while oral chronic use is dominated by long-term standard prescribing and generics.

3) What typically drives price erosion for nicardipine?

Generic entry and increased competition within the same dose strengths and route formats drive revenue decline even when unit demand remains steady.

4) What matters most for commercial planning?

Formulary and tender cycles, contract renewal timing, and manufacturing continuity are usually more predictive than clinical pipeline events for mature molecules.

5) Can a credible 5-year projection be produced without current market baselines?

No. A numeric projection requires current revenue/unit baselines, region segmentation, and expected price erosion and volume trajectories tied to identifiable contract or generic-entry milestones.

---

References (APA)

[1] ClinicalTrials.gov. (n.d.). Nicardipine hydrochloride. https://clinicaltrials.gov/
[2] U.S. Food and Drug Administration. (n.d.). Drug approval and related information for nicardipine. https://www.fda.gov/
[3] European Medicines Agency. (n.d.). Nicardipine-related EPARs and product information. https://www.ema.europa.eu/
[4] WHO International Clinical Trials Registry Platform (ICTRP). (n.d.). Nicardipine. https://trialsearch.who.int/