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Last Updated: October 27, 2020

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR ARGININE HYDROCHLORIDE

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505(b)(2) Clinical Trials for Arginine Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT02675660 Single and Multiple Doses of an Oral Formulation of L-Homoarginine in Healthy Human Subjects Completed Universitätsklinikum Hamburg-Eppendorf Phase 1 2014-04-01 This study represents an initial clinical evaluation of an oral formulation of L-homoarginine. L-homoarginine and L-arginine are amino acids found in food proteins and are both substrates for nitric oxide synthase (NOS). L-arginine is available as over the counter nutraceutical. This study will provide information on the dosing of L-homoarginine in order to reach high physiological plasma concentrations in humans.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Arginine Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000623 Thalassemia (Cooley's Anemia) Clinical Research Network (TCRN) Completed National Heart, Lung, and Blood Institute (NHLBI) N/A 2000-07-01 The purpose of the TCRN is to accelerate research in the management of thalassemia, standardize existing treatments, and evaluate new ones in a network of clinical centers in North America. The emphasis will be on clinical trials that help identify optimal therapy. Therapeutic trials may involve investigational drugs, drugs already approved but not currently used, and drugs currently used.
NCT00000623 Thalassemia (Cooley's Anemia) Clinical Research Network (TCRN) Completed Thalassemia Clinical Research Network N/A 2000-07-01 The purpose of the TCRN is to accelerate research in the management of thalassemia, standardize existing treatments, and evaluate new ones in a network of clinical centers in North America. The emphasis will be on clinical trials that help identify optimal therapy. Therapeutic trials may involve investigational drugs, drugs already approved but not currently used, and drugs currently used.
NCT00000623 Thalassemia (Cooley's Anemia) Clinical Research Network (TCRN) Completed New England Research Institutes N/A 2000-07-01 The purpose of the TCRN is to accelerate research in the management of thalassemia, standardize existing treatments, and evaluate new ones in a network of clinical centers in North America. The emphasis will be on clinical trials that help identify optimal therapy. Therapeutic trials may involve investigational drugs, drugs already approved but not currently used, and drugs currently used.
NCT00001436 A Phase I Study of OncoLAR® (Registered Trademark) (NSC 685403) With/Without Tamoxifen in Patients With Osteosarcoma Completed National Cancer Institute (NCI) Phase 1 1995-05-01 The suppression of IGF-I and growth hormone may significantly alter the pathobiology of osteosarcoma. SMS 201-955 pa LAR is a long acting analog of Somatostatin which inhibits the pituitary release of growth hormone, reducing levels of circulating IGF-I . Additional data on tamoxifen usage has also demonstrated a reduction in circulating IGF-I levels. The degree of suppression of IGF-I and growth hormone will be determined at two dose levels of SMS 291-955 pa LAR. Tamoxifen will be added to two of the cohorts to determine if the additive effects of tamoxifen and SMS 201-955 pa LAR will lead to additional reduction of circulating IGF-I and growth hormone levels. Arginine-stimulated GH tests to assess levels of growth hormone in the blood will be administered pre-treatment evaluation up to three times, one time on weeks 2, 8, 16, 28, 40, 52, and one month post last dose of SMS 201-955 pa LAR. The four cohorts for this study will receive 60 or 90 mg SMS 201-955 pa LAR injectable every four weeks for up to 52 weeks. Two of the cohorts will receive 10 mg Tamoxifen on a daily basis.
NCT00001752 Vascular and Metabolic Effects of Hormone Therapy Combined With L-Arginine in Postmenopausal Women Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 1998-09-01 Estrogen therapy has been associated with reduced risk of coronary heart disease events in observational studies of postmenopausal women. Although favorable effects of estrogen on lipoprotein cholesterol levels probably account for much of this benefit, direct vascular effects (vasomotor, hemostatic, anti-inflammatory) regulated by nitric oxide (NO) may also be of importance. We have recently shown that vasodilator effects of estrogen in the coronary circulation are due to enhanced bioactivity of NO released from the endothelium. Estrogen has been shown to stimulate synthesis and activity of the enzyme NO synthase with enhanced NO synthesis in endothelial cells in culture. Because L-arginine is the natural substrate for the enzyme NO synthase, we propose that the combination of L-arginine and estrogen might have additive vasomotor, hemostatic and anti-inflammatory effects in hypercholesterolemic postmenopausal women.
NCT00004360 Study of Genotype and Phenotype Expression in Congenital Nephrogenic Diabetes Insipidus Completed Northwestern University N/A 1995-09-01 OBJECTIVES: I. Determine the relationship between genotype variations and clinical phenotype in patients with congenital nephrogenic diabetes insipidus.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Arginine Hydrochloride

Condition Name

Condition Name for Arginine Hydrochloride
Intervention Trials
Hypertension 10
Healthy 9
Asthma 8
Cardiovascular Diseases 8
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Condition MeSH

Condition MeSH for Arginine Hydrochloride
Intervention Trials
Diabetes Mellitus 19
Hypertension 18
Anemia, Sickle Cell 14
Diabetes Mellitus, Type 2 11
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Clinical Trial Locations for Arginine Hydrochloride

Trials by Country

Trials by Country for Arginine Hydrochloride
Location Trials
United States 247
China 28
Italy 20
Canada 18
Germany 15
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Trials by US State

Trials by US State for Arginine Hydrochloride
Location Trials
California 28
Texas 26
New York 21
Massachusetts 16
Maryland 15
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Clinical Trial Progress for Arginine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Arginine Hydrochloride
Clinical Trial Phase Trials
Phase 4 45
Phase 3 36
Phase 2/Phase 3 13
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Clinical Trial Status

Clinical Trial Status for Arginine Hydrochloride
Clinical Trial Phase Trials
Completed 135
Recruiting 51
Not yet recruiting 36
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Clinical Trial Sponsors for Arginine Hydrochloride

Sponsor Name

Sponsor Name for Arginine Hydrochloride
Sponsor Trials
National Heart, Lung, and Blood Institute (NHLBI) 15
Polaris Group 10
Peking Union Medical College Hospital 8
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Sponsor Type

Sponsor Type for Arginine Hydrochloride
Sponsor Trials
Other 360
Industry 73
NIH 45
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