You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 29, 2025

CLINICAL TRIALS PROFILE FOR AMMONIA N 13


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for AMMONIA N 13

Trial IDTitleStatusSponsorPhaseStart DateSummary
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 5 of 5 entries

Clinical Trial Conditions for AMMONIA N 13

Condition Name

2666400510152025Hepatic EncephalopathyUrea Cycle DisordersCirrhosisAcute-On-Chronic Liver Failure[disabled in preview]
Condition Name for AMMONIA N 13
Intervention Trials
Hepatic Encephalopathy 26
Urea Cycle Disorders 6
Cirrhosis 6
Acute-On-Chronic Liver Failure 4
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

34341515005101520253035Brain DiseasesHepatic EncephalopathyLiver CirrhosisFibrosis[disabled in preview]
Condition MeSH for AMMONIA N 13
Intervention Trials
Brain Diseases 34
Hepatic Encephalopathy 34
Liver Cirrhosis 15
Fibrosis 15
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

+
Trials by US State for AMMONIA N 13
Location Trials
New York 14
California 11
Texas 11
Pennsylvania 10
Ohio 10
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for AMMONIA N 13

Clinical Trial Phase

37.9%13.6%9.1%39.4%046810121416182022242628Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for AMMONIA N 13
Clinical Trial Phase Trials
Phase 4 25
Phase 3 9
Phase 2/Phase 3 6
[disabled in preview] 26
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

43.2%17.9%15.8%23.2%0152025303540CompletedRecruitingNot yet recruiting[disabled in preview]
Clinical Trial Status for AMMONIA N 13
Clinical Trial Phase Trials
Completed 41
Recruiting 17
Not yet recruiting 15
[disabled in preview] 22
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for AMMONIA N 13

Sponsor Name

trials012345678Institute of Liver and Biliary Sciences, IndiaHorizon Pharma Ireland, Ltd., Dublin IrelandAssiut University[disabled in preview]
Sponsor Name for AMMONIA N 13
Sponsor Trials
Institute of Liver and Biliary Sciences, India 5
Horizon Pharma Ireland, Ltd., Dublin Ireland 5
Assiut University 4
[disabled in preview] 8
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

78.3%15.9%5.3%0020406080100120140160OtherIndustryNIH[disabled in preview]
Sponsor Type for AMMONIA N 13
Sponsor Trials
Other 148
Industry 30
NIH 10
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

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

Introduction to Ammonia N-13

Ammonia N-13, or 13N-ammonia, is a radioactive isotope of nitrogen that plays a crucial role in positron emission tomography (PET) imaging. It is widely used to assess myocardial perfusion, detect coronary artery disease, and evaluate various other medical conditions.

Clinical Trials and Research

Current Studies and Objectives

One notable clinical trial involving Ammonia N-13 is the "Ammonia N-13 Myocardial Blood Flow Absolute Quantification by PET in Patients with Known or Suspected CAD" study. This prospective, multicenter study aims to collect data on myocardial perfusion imaging (MPI) using N-13 Ammonia. The study involves enrolling patients scheduled for clinically indicated PET-MPI with N-13, collecting data on perfusion, myocardial blood flow (MBF), percent ischemia, and gated left ventricular ejection fraction/function values. This data will be anonymized and uploaded into a database to enhance the clinical value of measured blood flow values and perfusion images[1].

Data Collection and Analysis

The study focuses on collecting comprehensive data without performing any additional procedures beyond those clinically indicated. This approach ensures that the data is relevant and directly applicable to clinical practice. The anonymized data will help in understanding the efficacy and diagnostic accuracy of Ammonia N-13 in PET imaging.

Market Analysis

Market Size and Growth

The global Ammonia N-13 market is projected to experience significant growth. From 2023 to 2033, the market is expected to grow from USD 88.23 billion to USD 172.77 billion, reflecting a compound annual growth rate (CAGR) of approximately 6.3%[2].

Key Drivers

Several factors are driving the growth of the Ammonia N-13 market:

  • Increasing Prevalence of Cardiovascular and Neurological Disorders: The rising incidence of cardiovascular diseases and neurological disorders such as Alzheimer's and Parkinson's disease is driving the demand for advanced diagnostic tools like Ammonia N-13-based PET imaging.
  • Growing Demand for Advanced Medical Imaging Techniques: Healthcare providers and patients are seeking more accurate and non-invasive diagnostic methods, which is boosting the demand for Ammonia N-13.
  • Advancements in Production and Distribution: Improvements in manufacturing processes, supply chain management, and cost optimization are making Ammonia N-13 more accessible and affordable[2].

Market Opportunities

The Ammonia N-13 market presents several opportunities for growth:

  • Emerging Economies: Regions like the Asia-Pacific and Latin America are investing in healthcare infrastructure, creating a significant market for Ammonia N-13-based PET imaging.
  • Neurological Disorders: The use of Ammonia N-13 in evaluating neurological disorders offers substantial growth potential.
  • Regulatory Approvals and Partnerships: Strategic partnerships and regulatory approvals are further contributing to the market's expansion[2].

Regional Analysis

The market is globally distributed, with different regions showing varying levels of growth:

  • North America: Currently the largest market, driven by a well-established healthcare infrastructure and favorable regulatory environment.
  • Europe: Significant adoption in countries like Germany, the UK, and France, driven by the increasing prevalence of cardiovascular and neurological disorders.
  • Asia-Pacific: Poised to experience the highest growth rate, driven by rising healthcare awareness and investments in healthcare infrastructure in countries like China, Japan, and India[2].

Market Projections

Future Outlook

The future outlook for the Ammonia N-13 market is positive, with continued growth expected over the forecast period. Key drivers include:

  • Increasing Prevalence of Diseases: The ongoing rise in cardiovascular and neurological disorders will continue to drive demand.
  • Advancements in Technology: Improvements in production, distribution, and cost optimization will enhance accessibility and affordability.
  • Expansion into Emerging Economies: Growing healthcare infrastructure in regions like Asia-Pacific and Latin America will further boost the market[2].

Competitive Landscape

The market is characterized by the presence of both established pharmaceutical and medical imaging companies, as well as specialized radiopharmaceutical manufacturers. This competitive environment is driven by regulatory approvals, strategic partnerships, and continuous research and development activities[2].

Regulatory and Approval Status

Ammonia N-13 has been approved for use in the US since August 23, 2007. The regulatory environment continues to support the market's growth through favorable approvals and guidelines[4].

Conclusion

The Ammonia N-13 market is poised for significant growth driven by increasing demand for advanced medical imaging techniques, particularly in the diagnosis of cardiovascular and neurological disorders. Clinical trials and research studies are enhancing the clinical value of Ammonia N-13, while market projections indicate a robust future for this radiopharmaceutical.

Key Takeaways

  • Clinical Trials: Ongoing studies are focusing on the absolute quantification of myocardial blood flow using Ammonia N-13.
  • Market Growth: The global market is expected to grow from USD 88.23 billion in 2023 to USD 172.77 billion by 2033.
  • Key Drivers: Increasing prevalence of diseases, growing demand for advanced imaging, and advancements in production and distribution.
  • Regional Growth: North America, Europe, and the Asia-Pacific region are key markets with significant growth potential.
  • Regulatory Status: Approved in the US since 2007, with a favorable regulatory environment supporting market growth.

FAQs

Q: What is Ammonia N-13 used for in medical imaging?

A: Ammonia N-13 is used as a radiotracer in positron emission tomography (PET) scans to assess myocardial perfusion, detect coronary artery disease, and evaluate various other medical conditions.

Q: What is the projected growth rate of the Ammonia N-13 market?

A: The global Ammonia N-13 market is expected to grow at a CAGR of approximately 6.3% from 2024 to 2033[2].

Q: Which regions are expected to drive the growth of the Ammonia N-13 market?

A: North America, Europe, and the Asia-Pacific region are expected to be key drivers of the market's growth, with the Asia-Pacific region poised for the highest growth rate[2].

Q: What are the main drivers of the Ammonia N-13 market?

A: The main drivers include the increasing prevalence of cardiovascular and neurological disorders, the growing demand for advanced medical imaging techniques, and ongoing advancements in production and distribution[2].

Q: Is Ammonia N-13 approved for use in medical imaging?

A: Yes, Ammonia N-13 has been approved for use in the US since August 23, 2007[4].

Sources

  1. CenterWatch, "Ammonia N-13 Myocardial Blood Flow Absolute Quantification by PET in Patients with Known or Suspected CAD".
  2. DataHorizzonResearch, "Ammonia N 13 Market Size, Share, Growth, Statistics Report 2033".
  3. Ultragenyx, "Ultragenyx Completes Successful End-of-Phase 2 Meeting with FDA and Finalizes Phase 3 Study Design for DTX301".
  4. Synapse, "AMMONIA N-13 - Drug Targets, Indications, Patents".
  5. MarketResearchIntellect, "Global Ammonia N-13 Market Size, Trends and Projections".

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.