CLINICAL TRIALS PROFILE FOR NICARDIPINE HYDROCHLORIDE

All Clinical Trials for nicardipine hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.

Clinical Trial Conditions for nicardipine hydrochloride

Condition Name

Condition Name for nicardipine hydrochloride
Intervention	Trials
Hypertension	10
Intracerebral Hemorrhage	3
Subarachnoid Hemorrhage	3
COVID-19	2

Condition MeSH

Condition MeSH for nicardipine hydrochloride
Intervention	Trials
Hypertension	13
Hemorrhage	9
Cerebral Hemorrhage	6
Stroke	5

Clinical Trial Locations for nicardipine hydrochloride

Trials by Country

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Trials by Country for nicardipine hydrochloride
Location	Trials
United States	92
China	14
Australia	5
Korea, Republic of	5
Japan	5

Trials by US State

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−

Trials by US State for nicardipine hydrochloride
Location	Trials
Illinois	6
New York	6
Ohio	6
Pennsylvania	5
North Carolina	4

Clinical Trial Progress for nicardipine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for nicardipine hydrochloride
Clinical Trial Phase	Trials
Phase 4	14
Phase 3	11
Phase 2	7

Clinical Trial Status

Clinical Trial Status for nicardipine hydrochloride
Clinical Trial Phase	Trials
Completed	22
Not yet recruiting	10
Unknown status	6

Clinical Trial Sponsors for nicardipine hydrochloride

Sponsor Name

Sponsor Name for nicardipine hydrochloride
Sponsor	Trials
Yonsei University	4
The Medicines Company	4
Kafrelsheikh University	3

Sponsor Type

Sponsor Type for nicardipine hydrochloride
Sponsor	Trials
Other	148
Industry	12
NIH	3

Nicardipine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Nicardipine Hydrochloride

Nicardipine hydrochloride is a calcium channel blocker widely used in the treatment of hypertension and angina. Here, we will delve into the current state of clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Efficacy in Hypertension and Angina

Nicardipine hydrochloride has been extensively evaluated in clinical trials for its efficacy in treating mild to moderate hypertension and chronic stable angina. In 12 double-blind, parallel-group studies, including four placebo-controlled trials, nicardipine demonstrated significant reductions in supine systolic and diastolic blood pressure by 10 to 15 mm Hg and 10 mm Hg, respectively[3].

For patients with angina, nine double-blind, crossover design studies showed consistent and statistically significant improvements in exercise tolerance and time to onset of angina. These studies included comparisons with beta blockers and nifedipine, further solidifying nicardipine's efficacy[3].

Safety Profile

Clinical trials have also highlighted the safety profile of nicardipine hydrochloride. No deaths or serious adverse reactions were attributed to the drug. Common side effects include flushing, palpitations, headache, and pedal edema, primarily due to its vasodilatory effects[3].

Current and Ongoing Trials

While specific details on current ongoing trials are not provided in the sources, it is clear that nicardipine hydrochloride continues to be a subject of interest in medical research. Its use in various clinical settings, including short-term treatment of hypertension when oral therapy is not feasible, remains a focus area[4].

Market Analysis

Market Size and Growth

The Nicardipine Hydrochloride Tablets Market has experienced rapid and substantial growth in recent years. The market is projected to continue this upward trend from 2023 to 2031, with significant growth rates anticipated. The market size is categorized based on type (ordinary and sustained release) and application (treating high blood pressure, relieving angina, and others), as well as geographical regions[2].

Geographical Segmentation

The market is segmented into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. Each region's market dynamics, including product pricing, penetration, and consumer behavior, are thoroughly analyzed to provide a comprehensive market outlook[2].

Key Players

The market report identifies several key players in the Nicardipine Hydrochloride API market, including Msn Laboratories Private Ltd, Gland Pharma Ltd, Hikma Pharmaceuticals, and others. These companies are profiled based on their product offerings and market-related factors, providing valuable insights into the competitive landscape[5].

Market Projections

Forecast Period

From 2023 to 2031, the Nicardipine Hydrochloride Tablets Market is expected to undergo significant development. The report forecasts robust growth rates, driven by increasing demand for effective hypertension and angina treatments. The market's evolution will be influenced by growth drivers, obstacles, opportunities, and challenges, which are thoroughly examined using frameworks like Porter's 5 Forces and macroeconomic evaluations[2].

Revenue and CAGR

The North American market for Nicardipine Hydrochloride API, for instance, is projected to grow at a notable CAGR from 2023 to 2030. While exact figures are not provided, the trend indicates a substantial increase in revenue over the forecast period[5].

Market Dynamics

Drivers and Restraints

The market is driven by the increasing prevalence of hypertension and angina, coupled with the need for effective and reliable treatment options. However, restraints such as potential side effects and the availability of alternative treatments also play a role in shaping the market dynamics[2].

Opportunities and Challenges

Opportunities for growth include expanding into new geographical markets and developing sustained-release formulations. Challenges may arise from regulatory changes, competition from generic drugs, and the need for continuous innovation to stay ahead in the market[2].

Product Formulations and Usage

Oral and Intravenous Formulations

Nicardipine hydrochloride is available in both oral and intravenous formulations. The intravenous form is particularly useful for short-term treatment of hypertension when oral therapy is not feasible or desirable. This formulation must be diluted before infusion and is closely monitored to avoid rapid or excessive blood pressure drops[4].

Indications and Usage

The drug is indicated for the treatment of hypertension and angina. For prolonged blood pressure control, patients are typically transferred to oral medication as soon as their clinical condition permits. It is contraindicated in patients with advanced aortic stenosis and requires careful monitoring in patients with angina, heart failure, or impaired hepatic or renal function[4].

Safety and Precautions

Adverse Reactions

Common adverse reactions include flushing, palpitations, headache, and pedal edema. Serious adverse reactions are rare, but the drug can cause decreased oxygen saturation in some cases. It is classified as Pregnancy Category C, indicating potential fetal harm, and is minimally excreted into human milk[3][4].

Key Takeaways

• Clinical Efficacy: Nicardipine hydrochloride has demonstrated significant efficacy in treating hypertension and angina in clinical trials.
• Market Growth: The market is projected to experience robust growth from 2023 to 2031, driven by increasing demand and geographical expansion.
• Key Players: Several major pharmaceutical companies are involved in the production and distribution of nicardipine hydrochloride.
• Safety Profile: The drug has a generally safe profile but requires careful monitoring and has specific contraindications.
• Formulations: Available in both oral and intravenous forms, each with specific indications and usage guidelines.

FAQs

What is nicardipine hydrochloride used for?

Nicardipine hydrochloride is used for the treatment of hypertension and angina.

What are the common side effects of nicardipine hydrochloride?

Common side effects include flushing, palpitations, headache, and pedal edema.

Can nicardipine hydrochloride be used in pregnant women?

Nicardipine hydrochloride is classified as Pregnancy Category C, indicating potential fetal harm, and should only be used if the potential benefit justifies the risk.

What are the contraindications for nicardipine hydrochloride?

The drug is contraindicated in patients with advanced aortic stenosis.

Is nicardipine hydrochloride available in different formulations?

Yes, it is available in both oral and intravenous formulations.

Sources

1. Pendopharm, Inc. - Drug pipelines, Patents, Clinical trials - Synapse
2. Nicardipine Hydrochloride Tablets Market Size, Scope And Forecast ...
3. An overview of the safety and efficacy of nicardipine in clinical trials
4. American Regent Introduces Nicardipine Hydrochloride Injection ...
5. Nicardipine Hydrochloride API - Market - Valuates Reports