CLINICAL TRIALS PROFILE FOR AMMONIA N-13

All Clinical Trials for AMMONIA N-13

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00281502 ↗	The Role of Bacterial Overgrowth and Delayed Intestinal Transit in Hepatic Encephalopathy	Unknown status	Bausch Health Americas, Inc.	Phase 2	2005-12-01	The study will be conducted in two phases. Phase A will evaluate the contribution of bacterial overgrowth and colonic inertia to development of Hepatic Encephalopathy (HE)in 50 ambulatory subjects with HE and hepatitis C cirrhosis. This phase will include a Screening and Evaluation Visit. Phase B will evaluate the effect of rifaximin on bacterial outgrowth and severity of HE in 20 of the subjects enrolled in Phase A who have a somewhat greater degree of encephalopathy. The purpose of this study is to evaluate the following: 1. the relationship between bacterial overgrowth and the presence and severity of HE in patients with hepatitis C cirrhosis; 2. the effectiveness and tolerability of rifaximin relative to placebo in treatment of HE associated with hepatitis C cirrhosis; 3. the relationship between bacterial overgrowth and the presence and severity of HE before and after rifaximin treatment.
NCT00233012 ↗	A Study of the Pharmacokinetics, Safety and Tolerability of Topiramate in Infants (Age 1-24 Months) With Refractory Partial-onset Seizures	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 1	2005-06-01	The purpose of this study is to evaluate the pharmacokinetics safety and tolerability of topiramate in infants aged 1-24 months with refractory partial-onset seizures. Topiramate is an antiepileptic drug approved for use in adult and pediatric patients (aged 2 to 16 years) with refractory partial onset seizures (POS) with or without secondarily generalized seizures, primary generalized tonic clonic seizures, or Lennox-Gastaut syndrome (LGS).
NCT00134433 ↗	Endothelial Modulation for Angiogenic Therapy	Completed	Heart and Stroke Foundation of Ontario	Phase 1/Phase 2	2004-11-01	Coronary artery disease is the single most important killer of Canadians. Despite major advances in therapy, there is still a significant proportion of patients identified with the disease who die of it because current treatment approaches cannot effectively palliate their condition. A new treatment modality called therapeutic angiogenesis has appeared on the clinical research scene during the last five years; this approach recreates the natural processes of new blood vessel formation that is observed during growth and development in every human being. It is an extremely potent and promising modality, but so far the results of clinical trials in patients have been equivocal. One reason for the limited efficacy observed thus far with therapeutic angiogenesis may rest in that factors produced by the lining of the coronary arteries themselves are essential for angiogenic substances to take effect in the heart muscle of patients with severe coronary artery disease. These same patients, however, virtually all have, as a result of their disease, marked dysfunction of their coronaries and therefore fail to produce these factors in adequate quantities. This hypothesis has been verified with extensive animal data by the investigators of this research, where a swine model of coronary disease was shown to severely inhibit the action of angiogenic growth factors. If one wants angiogenesis to work, a means of improving the function of the coronary lining of patients with severe ischemic heart disease must be identified and its effects evaluated in order to allow for angiogenic substances to exert their action towards successful revascularization of the heart muscle. An amino acid called L-arginine has repeatedly been shown to markedly improve function of the coronary artery lining in patients with ischemic heart disease when administered regularly over a period of several months. This research will therefore test, in the form of a randomized clinical trial, whether this concomitant approach can make angiogenesis effective in patients with advanced coronary disease, by allowing for the action of growth factors to take place in the heart. If this approach is successful, as is anticipated, angiogenesis will constitute an effective modality for the treatment of coronary artery disease, not only in patients with advanced, severe involvement unamenable to any other form of cardiac therapy such as coronary artery bypass grafting, but even perhaps in all patients with coronary artery disease in need of revascularization. The goal of this investigation towards the making of a new, revolutionary, safe and efficacious modality for the treatment of the number one killer disease of Canadians is in complete agreement with the primary objective of the Heart and Stroke Foundation of Canada.
NCT00134433 ↗	Endothelial Modulation for Angiogenic Therapy	Completed	Ottawa Heart Institute Research Corporation	Phase 1/Phase 2	2004-11-01	Coronary artery disease is the single most important killer of Canadians. Despite major advances in therapy, there is still a significant proportion of patients identified with the disease who die of it because current treatment approaches cannot effectively palliate their condition. A new treatment modality called therapeutic angiogenesis has appeared on the clinical research scene during the last five years; this approach recreates the natural processes of new blood vessel formation that is observed during growth and development in every human being. It is an extremely potent and promising modality, but so far the results of clinical trials in patients have been equivocal. One reason for the limited efficacy observed thus far with therapeutic angiogenesis may rest in that factors produced by the lining of the coronary arteries themselves are essential for angiogenic substances to take effect in the heart muscle of patients with severe coronary artery disease. These same patients, however, virtually all have, as a result of their disease, marked dysfunction of their coronaries and therefore fail to produce these factors in adequate quantities. This hypothesis has been verified with extensive animal data by the investigators of this research, where a swine model of coronary disease was shown to severely inhibit the action of angiogenic growth factors. If one wants angiogenesis to work, a means of improving the function of the coronary lining of patients with severe ischemic heart disease must be identified and its effects evaluated in order to allow for angiogenic substances to exert their action towards successful revascularization of the heart muscle. An amino acid called L-arginine has repeatedly been shown to markedly improve function of the coronary artery lining in patients with ischemic heart disease when administered regularly over a period of several months. This research will therefore test, in the form of a randomized clinical trial, whether this concomitant approach can make angiogenesis effective in patients with advanced coronary disease, by allowing for the action of growth factors to take place in the heart. If this approach is successful, as is anticipated, angiogenesis will constitute an effective modality for the treatment of coronary artery disease, not only in patients with advanced, severe involvement unamenable to any other form of cardiac therapy such as coronary artery bypass grafting, but even perhaps in all patients with coronary artery disease in need of revascularization. The goal of this investigation towards the making of a new, revolutionary, safe and efficacious modality for the treatment of the number one killer disease of Canadians is in complete agreement with the primary objective of the Heart and Stroke Foundation of Canada.
NCT00194688 ↗	Breath Ammonia Method for H. Pylori Detection: Phase II	Completed	National Institutes of Health (NIH)	Phase 2	2003-03-01	The objective is to evaluate the utility of a breath ammonia sensing device. In this study we will assess the effect of H. pylori infection on breath ammonia levels by measuring whether there is a change in the pattern or quantity of breath ammonia seen in H. pylori positive patients compared to H. pylori negative patients.
NCT00194688 ↗	Breath Ammonia Method for H. Pylori Detection: Phase II	Completed	University of Washington	Phase 2	2003-03-01	The objective is to evaluate the utility of a breath ammonia sensing device. In this study we will assess the effect of H. pylori infection on breath ammonia levels by measuring whether there is a change in the pattern or quantity of breath ammonia seen in H. pylori positive patients compared to H. pylori negative patients.

Clinical Trial Conditions for AMMONIA N-13

Condition Name

Condition Name for AMMONIA N-13
Intervention	Trials
Hepatic Encephalopathy	26
Urea Cycle Disorders	6
Cirrhosis	6
Acute-On-Chronic Liver Failure	4

Condition MeSH

Condition MeSH for AMMONIA N-13
Intervention	Trials
Hepatic Encephalopathy	34
Brain Diseases	34
Fibrosis	15
Liver Cirrhosis	15

Clinical Trial Locations for AMMONIA N-13

Trials by Country

+

−

Trials by Country for AMMONIA N-13
Location	Trials
United States	142
India	15
China	14
Spain	8
Canada	7

Trials by US State

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−

Trials by US State for AMMONIA N-13
Location	Trials
New York	14
California	11
Texas	11
Ohio	10
District of Columbia	10

Clinical Trial Progress for AMMONIA N-13

Clinical Trial Phase

Clinical Trial Phase for AMMONIA N-13
Clinical Trial Phase	Trials
Phase 4	25
Phase 3	9
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for AMMONIA N-13
Clinical Trial Phase	Trials
Completed	41
Recruiting	17
Not yet recruiting	15

Clinical Trial Sponsors for AMMONIA N-13

Sponsor Name

Sponsor Name for AMMONIA N-13
Sponsor	Trials
Horizon Pharma Ireland, Ltd., Dublin Ireland	5
Institute of Liver and Biliary Sciences, India	5
Postgraduate Institute of Medical Education and Research	4

Sponsor Type

Sponsor Type for AMMONIA N-13
Sponsor	Trials
Other	148
Industry	30
NIH	10

Ammonia N-13: Clinical Trials, Market Analysis, and Projections

Introduction

Ammonia N-13, a radioactive isotope of ammonia, is a crucial diagnostic radiopharmaceutical used primarily in Positron Emission Tomography (PET) imaging. This article delves into the current clinical trials, market analysis, and future projections for Ammonia N-13, highlighting its significance in medical diagnostics and the factors driving its market growth.

Clinical Trials and Usage

Myocardial Perfusion Imaging

Ammonia N-13 is widely used in myocardial perfusion imaging (MPI) to assess blood flow to the heart muscle. A significant clinical trial involves the use of Ammonia N-13 PET scans to visualize and quantify blood flow in patients with known or suspected coronary artery disease (CAD)[1].

• Study Design: This prospective, multicenter study aims to collect data from patients undergoing clinically indicated PET-MPI with Ammonia N-13. The study includes parameters such as perfusion, myocardial blood flow (MBF), percent ischemia, and left ventricular ejection fraction/function.
• Clinical Value: Research has shown that reviewing both the measured blood flow values and the perfusion images provides significant clinical value in diagnosing and managing CAD.

Diagnostic Applications

Beyond cardiovascular diseases, Ammonia N-13 is also used in the evaluation of neurological disorders and oncology. Its ability to provide detailed images of blood flow makes it a valuable tool in various medical conditions[2].

Market Analysis

Market Size and Growth

The global Ammonia N-13 market is projected to experience exponential growth, driven by the increasing demand for advanced medical imaging technologies.

• CAGR: The market is expected to grow at a Compound Annual Growth Rate (CAGR) of approximately 7.8% from 2024 to 2033[2].
• Market Drivers: The rising incidence of cardiovascular and neurological disorders, along with advancements in production and distribution, are key drivers of this growth.

Key Players and Competitive Landscape

The market is characterized by the presence of both established players and specialized radiopharmaceutical manufacturers.

• Established Players: Companies like GE Healthcare, Siemens Healthineers, and Bracco Imaging dominate the market.
• Specialized Manufacturers: These players are focused on improving production techniques, increasing availability, and enhancing the safety and efficacy of Ammonia N-13 radiopharmaceuticals[2].

Regulatory Approvals

Regulatory approvals, such as FDA approval, have significantly contributed to the market's growth and acceptance among healthcare providers.

• FDA Approval: The FDA approval of Ammonia N-13 for use in PET imaging has been a crucial factor in its widespread adoption[2].

Market Opportunities

Cardiovascular Diseases

The increasing prevalence of cardiovascular diseases, such as coronary artery disease and heart failure, presents a significant opportunity for the Ammonia N-13 market.

• Early Diagnosis and Management: Ammonia N-13-based PET imaging enables early diagnosis and effective management of these conditions, driving demand for this diagnostic tool[2].

Neurological Disorders

The growing prevalence of neurological disorders, including Alzheimer's disease and Parkinson's disease, also drives the demand for Ammonia N-13-based PET imaging.

• Early Detection and Monitoring: These advanced imaging techniques aid in the early detection and monitoring of neurological conditions, facilitating targeted treatment strategies[2].

Regional Analysis

North America

North America, particularly the United States, is currently the largest market for Ammonia N-13, driven by a well-established healthcare infrastructure and favorable regulatory environment[2].

Europe

Europe is another significant market, with countries like Germany, the UK, and France showing growing adoption of Ammonia N-13-based PET imaging[2].

Asia-Pacific

The Asia-Pacific region is poised to experience the highest growth rate during the forecast period, driven by rising healthcare awareness, a growing middle-class population, and increasing investments in healthcare infrastructure[2].

Future Outlook

Continued Growth

The future outlook for the Ammonia N-13 market is positive, with ongoing advancements in production and distribution expected to enhance accessibility and affordability.

• Improvements in Manufacturing: Advances in manufacturing processes, supply chain management, and cost optimization will contribute to the market's growth[2].

Expansion into Emerging Economies

The expansion of the Ammonia N-13 market into emerging economies, particularly in the Asia-Pacific and Latin American regions, presents significant opportunities for market players.

• Healthcare Infrastructure: These regions are investing in healthcare infrastructure and seeking to enhance their diagnostic capabilities, aligning with the growing demand for Ammonia N-13-based PET imaging[2].

Key Takeaways

• Clinical Trials: Ammonia N-13 is being used in clinical trials to improve the diagnosis and management of cardiovascular diseases through advanced PET imaging.
• Market Growth: The global Ammonia N-13 market is expected to grow at a CAGR of approximately 7.8% from 2024 to 2033.
• Market Drivers: Increasing prevalence of cardiovascular and neurological disorders, along with advancements in production and distribution, drive the market.
• Regional Growth: North America and Europe are current leaders, while the Asia-Pacific region is expected to show the highest growth rate.
• Future Outlook: The market is expected to continue growing, driven by improvements in manufacturing and expansion into emerging economies.

FAQs

What is Ammonia N-13 used for in medical diagnostics?

Ammonia N-13 is used primarily in PET imaging to assess myocardial perfusion, detect coronary artery disease, and evaluate various other medical conditions, including neurological disorders and oncology[2].

What is the current market size and growth rate of the Ammonia N-13 market?

The global Ammonia N-13 market is projected to grow at a CAGR of approximately 7.8% from 2024 to 2033, with the market expected to expand significantly during this period[2].

Which regions are expected to show the highest growth in the Ammonia N-13 market?

The Asia-Pacific region is expected to experience the highest growth rate during the forecast period, driven by rising healthcare awareness and investments in healthcare infrastructure[2].

What are the key drivers of the Ammonia N-13 market?

The key drivers include the increasing prevalence of cardiovascular and neurological disorders, growing demand for advanced medical imaging techniques, and ongoing advancements in the production and distribution of Ammonia N-13 radiopharmaceuticals[2].

Who are the major players in the Ammonia N-13 market?

Major players include established companies like GE Healthcare, Siemens Healthineers, and Bracco Imaging, as well as specialized radiopharmaceutical manufacturers[2].

Sources

1. CenterWatch: Ammonia N-13 Myocardial Blood Flow Absolute Quantification by PET in Patients with Known or Suspected CAD - Ammonia MAP[1].
2. DataHorizon Research: Ammonia N 13 Market Size, Share, Growth, Statistics Report 2033[2].
3. GlobeNewswire: Ammonia Market Projected to Reach USD 121.5 Billion by 2032[5].
4. Synapse: AMMONIA N-13 - Drug Targets, Indications, Patents[4].