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Generated: November 15, 2018

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CLINICAL TRIALS PROFILE FOR AMMONIA N 13

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Clinical Trials for Ammonia N 13

Trial ID Title Status Sponsor Phase Summary
NCT00134433 Endothelial Modulation for Angiogenic Therapy Completed Heart and Stroke Foundation of Ontario Phase 1/Phase 2 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 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 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 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.
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 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).
NCT00281502 The Role of Bacterial Overgrowth and Delayed Intestinal Transit in Hepatic Encephalopathy Unknown status Valeant Pharmaceuticals International, Inc. Phase 2 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Ammonia N 13

Condition Name

Condition Name for Ammonia N 13
Intervention Trials
Hepatic Encephalopathy 15
Urea Cycle Disorders 5
Cirrhosis 4
Liver Cirrhosis 4
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Condition MeSH

Condition MeSH for Ammonia N 13
Intervention Trials
Hepatic Encephalopathy 22
Brain Diseases 22
Fibrosis 12
Liver Cirrhosis 11
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Clinical Trial Locations for Ammonia N 13

Trials by Country

Trials by Country for Ammonia N 13
Location Trials
United States 119
China 11
India 10
Canada 5
United Kingdom 3
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Trials by US State

Trials by US State for Ammonia N 13
Location Trials
New York 12
California 11
Texas 9
District of Columbia 8
Pennsylvania 7
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Clinical Trial Progress for Ammonia N 13

Clinical Trial Phase

Clinical Trial Phase for Ammonia N 13
Clinical Trial Phase Trials
Phase 4 16
Phase 3 5
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Ammonia N 13
Clinical Trial Phase Trials
Completed 29
Recruiting 14
Unknown status 6
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Clinical Trial Sponsors for Ammonia N 13

Sponsor Name

Sponsor Name for Ammonia N 13
Sponsor Trials
Horizon Pharma Ireland, Ltd., Dublin Ireland 5
Mendel Tuchman 3
Institute of Liver and Biliary Sciences, India 3
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Sponsor Type

Sponsor Type for Ammonia N 13
Sponsor Trials
Other 93
Industry 21
NIH 8
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Serving hundreds of leading biopharmaceutical companies globally:

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Daiichi Sankyo
Citi
Johnson and Johnson
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Colorcon
Boehringer Ingelheim

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