CLINICAL TRIALS PROFILE FOR CORLOPAM

All Clinical Trials for CORLOPAM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00982527 ↗	Fenoldopam in Pediatric Cardiac Surgery	Completed	Bambino Gesù Hospital and Research Institute	Phase 3	2009-09-01	The purpose of this study is to determine whether fenoldopam infusion during cardiopulmonary bypass in young children with congenital heart disease is able to reduce indicators of acute kidney injury (biomarkers reduction, diuresis increase) compared to a control group.
NCT00747331 ↗	Fenoldopam and Splanchnic Perfusion During Cardiopulmonary Bypass	Completed	IRCCS Policlinico S. Donato	Phase 4	2008-09-01	Cardiopulmonary bypass (CPB) for cardiac operations may be accompanied by different patterns of visceral underperfusion. This could result in clinical patterns of lactic acidosis but in the most severe cases there is the risk for mesenteric infarction (0.2% of the cases). Renal function as well may be impaired due to a low oxygen delivery, and acute renal failure occurs in 1-2% of cases. Fenoldopam mesilate is a selective splanchnic vasodilator when used at a dose < 0.1 mcg/kg/min. The experimental hypothesis of this randomized, controlled trial (RCT) is that the use of fenoldopam may determine a better visceral perfusion during CPB.
NCT00621790 ↗	Fenoldopam and Acute Renal Failure	Completed	Università Vita-Salute San Raffaele	Phase 3	2008-02-01	Patients undergoing cardiac surgery could develop postoperative acute renal failure requiring renal replacement therapy. Fenoldopam, already used for patients with hypertensive emergencies, could improve renal function in critically ill patients with or at risk for acute renal failure.
NCT01324245 ↗	Intervention Study to Compare the Natriuretic Effects of Enalapril on Low and High Salt Diet	Completed	University of Virginia	N/A	2002-11-01	The kidney plays a crucial role in maintaining salt balance by two opposing physiological mechanisms: the renal dopaminergic system which enhances salt excretion and the renin-angiotensin system (RAS) which causes salt retention. Salt-sensitive hypertension occurs when this balance is altered or abnormal. We hypothesized that this balance is influenced by salt intake: therefore dietary salt affects the natriuretic response to the renal dopaminergic agonist Fenoldopam, and the Angiotensin Converting Enzyme inhibitor, Enalapril. In this trial we study normal salt balance mechanisms in salt resistant adults with normal blood pressure.
NCT00122018 ↗	An Investigation of N-acetylcysteine and Fenoldopam as Renal Protection Agents for Cardiac Surgery	Completed	Abbott	Phase 2	2002-05-01	Patients with abnormal kidney function are at increased risk for complications following heart surgery, including worsening kidney function possibly requiring dialysis, a prolonged stay in the critical care unit and hospital, and the increased risk of death. Prior attempts at kidney protection for heart surgery patients have had mixed results. Two medicines, fenoldopam and N-acetylcysteine, have been shown to protect kidney function in other circumstances that cause kidney stress. The purpose of this study is to determine whether these medications will help to maintain the function of diseased kidneys during heart surgery.
NCT00122018 ↗	An Investigation of N-acetylcysteine and Fenoldopam as Renal Protection Agents for Cardiac Surgery	Completed	Linda F. Barr, M.D.	Phase 2	2002-05-01	Patients with abnormal kidney function are at increased risk for complications following heart surgery, including worsening kidney function possibly requiring dialysis, a prolonged stay in the critical care unit and hospital, and the increased risk of death. Prior attempts at kidney protection for heart surgery patients have had mixed results. Two medicines, fenoldopam and N-acetylcysteine, have been shown to protect kidney function in other circumstances that cause kidney stress. The purpose of this study is to determine whether these medications will help to maintain the function of diseased kidneys during heart surgery.

Clinical Trial Conditions for CORLOPAM

Condition Name

Condition Name for CORLOPAM
Intervention	Trials
Kidney Failure, Acute	2
Cardiac Surgical Procedures	1
Cardiopulmonary Bypass	1
Kidney Failure, Chronic	1

Condition MeSH

Condition MeSH for CORLOPAM
Intervention	Trials
Acute Kidney Injury	3
Renal Insufficiency	3
Hypertension	1
Hypersensitivity	1

Clinical Trial Locations for CORLOPAM

Trials by Country

+

−

Trials by Country for CORLOPAM
Location	Trials
Italy	3
United States	1

Trials by US State

+

−

Trials by US State for CORLOPAM
Location	Trials
District of Columbia	1

Clinical Trial Progress for CORLOPAM

Clinical Trial Phase

Clinical Trial Phase for CORLOPAM
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for CORLOPAM
Clinical Trial Phase	Trials
Completed	5

Clinical Trial Sponsors for CORLOPAM

Sponsor Name

Sponsor Name for CORLOPAM
Sponsor	Trials
Abbott	1
Linda F. Barr, M.D.	1
Università Vita-Salute San Raffaele	1

Sponsor Type

Sponsor Type for CORLOPAM
Sponsor	Trials
Other	6
Industry	1

Clinical Trials, Market Analysis, and Projections for CORLOPAM (Fenoldopam Mesylate)

Introduction to CORLOPAM

CORLOPAM, also known as fenoldopam mesylate, is a drug used primarily to manage severe hypertension when rapid, quickly reversible emergency intervention is clinically indicated, including some cases of hypertensive emergencies. It is administered intravenously and works by stimulating dopamine-1 receptors, leading to vasodilation and a subsequent decrease in blood pressure.

Clinical Trials Experience

Controlled Clinical Trials

In controlled clinical trials, patients have received intravenous fenoldopam for periods as long as 48 hours. These trials have shown that the drug's effects are rapid, with significant reductions in blood pressure observed as early as 5 minutes after the start of the infusion. The maximum effect is typically seen at a dose of 0.8 mcg/kg/min, with higher doses not providing additional decreases in mean arterial pressure (MAP) but potentially worsening tachycardia[5].

Pharmacodynamic Effects

Studies have demonstrated that the pharmacodynamic effects of fenoldopam are dose-dependent. The lowest dosage at which decreases in MAP were observed was 0.2 mcg/kg/min, and the dose at which the maximum effect was seen was 0.8 mcg/kg/min. There was some suggestion of partial tolerance at 48 hours in the higher dose infusions, but a substantial effect persisted throughout the treatment period[5].

Adverse Reactions

Clinical trials and post-approval use have identified several adverse reactions associated with CORLOPAM. These include cardiac disorders such as cardiogenic shock, vascular disorders like hypotension, gastrointestinal disorders like abdominal distension, and investigations showing electrocardiogram ST segment depression and decreased oxygen saturation[1].

Market Analysis

Current Market Status

The market for antihypertensive drugs, including CORLOPAM, is influenced by several factors. The global demand for these drugs is driven by the increasing prevalence of cardiovascular diseases. According to the World Heart Federation, nearly 15 million people suffer from heart attacks or related problems globally each year, which sustains the demand for antihypertensive medications[3].

Geographical Outlook

The market for CORLOPAM and similar antihypertensive drugs is strong in regions with robust healthcare infrastructure and high affordability, such as North America and Europe. However, the Asia Pacific region, with countries like China, India, and Japan, is emerging as a significant market due to improving healthcare sectors, favorable government policies, and increasing disposable income among the urban population[3].

Competitive Landscape

The antihypertensive drug market faces competition from various generic products, especially after the patent expiry of key drugs. For instance, the patent expiry of clopidogrel in 2013 opened up the market for numerous generic manufacturers, reducing overall profitability but maintaining growth due to the vast patient base[3].

Market Projections

Growth Drivers

The market for CORLOPAM and other antihypertensive drugs is expected to grow driven by several factors:

• Increasing Prevalence of Cardiovascular Diseases: The rising number of patients suffering from cardiovascular diseases globally will continue to drive the demand for antihypertensive medications.
• Advancements in Healthcare Infrastructure: Improvements in healthcare infrastructure, particularly in emerging economies, will enhance access to these drugs.
• Generic Market: Although the entry of generic products reduces profitability, it also expands the market reach and accessibility of antihypertensive drugs[3].

Future Growth

The global market for antihypertensive drugs, including CORLOPAM, is anticipated to embark on a healthy growth path. The Asia Pacific region is expected to be a major consumer due to its large population and improving healthcare sector. The market is projected to grow steadily over the next few years, driven by the increasing demand for effective hypertension management solutions.

Impact of Omics-Based Clinical Trials

Integration of Omics Data

The integration of omics data in clinical trials is becoming increasingly important for improving drug efficacy and safety. Omics-based trials, which include genomic, proteomic, and metabolomic data, provide valuable insights into patient-specific responses at a molecular level. This approach can help in identifying potential adverse effects and optimizing dosing early in the drug development process, which could benefit drugs like CORLOPAM[4].

Regulatory Support

Regulatory bodies are recognizing the capabilities of omics data to enhance clinical trial research. This support is expected to drive the growth of the omics-based clinical trials market, which in turn could influence the development and approval of antihypertensive drugs like CORLOPAM[4].

Key Takeaways

• Clinical Trials: CORLOPAM has been shown to be effective in managing severe hypertension in clinical trials, with rapid and reversible effects.
• Adverse Reactions: The drug is associated with several adverse reactions, including cardiogenic shock, hypotension, and gastrointestinal disorders.
• Market Analysis: The antihypertensive drug market is driven by the increasing prevalence of cardiovascular diseases and improvements in healthcare infrastructure.
• Geographical Outlook: North America and Europe are current leaders, but the Asia Pacific region is emerging as a significant market.
• Future Growth: The market is expected to grow steadily, driven by increasing demand and advancements in healthcare infrastructure.
• Omics-Based Clinical Trials: The integration of omics data in clinical trials is expected to improve drug efficacy and safety, potentially benefiting CORLOPAM.

FAQs

What is CORLOPAM used for?

CORLOPAM (fenoldopam mesylate) is used to manage severe hypertension when rapid, quickly reversible emergency intervention is clinically indicated.

What are the common adverse reactions associated with CORLOPAM?

Common adverse reactions include cardiogenic shock, hypotension, abdominal distension, electrocardiogram ST segment depression, and decreased oxygen saturation.

How long can CORLOPAM be administered intravenously?

CORLOPAM can be administered intravenously for periods as long as 48 hours.

What drives the demand for antihypertensive drugs like CORLOPAM?

The demand is driven by the increasing prevalence of cardiovascular diseases and improvements in healthcare infrastructure, particularly in emerging economies.

How do omics-based clinical trials impact the development of drugs like CORLOPAM?

Omics-based clinical trials provide valuable insights into patient-specific responses, helping to identify potential adverse effects and optimize dosing early in the development process, which can enhance the efficacy and safety of drugs like CORLOPAM.

Sources

1. Pfizer Medical Information: CORLOPAM (fenoldopam mesylate injection, USP) Adverse Reactions.
2. FDA: Fenoldopam Mesylate - accessdata.fda.gov.
3. Biospace: Clopidogrel Market Latest Trends and Future Growth Detailed Analysis to 2025.
4. Biospace: Omics-based Clinical Trials Market Size to Hit USD 70.92 Billion by 2034.
5. FDA: Corlopam® - accessdata.fda.gov.