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Generated: December 18, 2018

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CLINICAL TRIALS PROFILE FOR GUANIDINE HYDROCHLORIDE

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Clinical Trials for Guanidine Hydrochloride

Trial ID Title Status Sponsor Phase Summary
NCT01038050 Study Effects of Ginkgo Biloba Extract on Endothelial Cell Function and Genetic Effects on the Response to Ginkgo Biloba Extract in Diabetic Patients With Stable Coronary Artery Disease Enrolling by invitation Taipei Veterans General Hospital, Taiwan Phase 4 Type 2 diabetes is associated with a markedly increased risk for atherosclerotic coronary arteries and cerebrovascular diseases. The major cause of death in diabetic patients is cardiovascular disease in the world including Taiwan. Atherosclerosis is a progressive disease characterized by the response of the vessel wall to chronic, multifactorial injury, which leads ultimately to the formation of atheromatous or fibrous plaques. Endothelial dysfunction is thought to be the initial stage of atherosclerosis. Endothelial dysfunction leads to impaired control of vascular tone, a decreased in the release of anti-inflammatory factors and reduced availability of nitric oxide. Endothelial dysfunction portends diabetic vasculopathy. The loss of intact endothelial integrity and function sets in motion a cascade of serial events that lead to atherosclerosis and cardiovascular complications. The standard extracts of G. biloba leaves [G. biloba extract (GBE)] are now demonstrated the cardiovascular, cerebrovascular and neuroprotective effects. The mixture of biologically active ingredients in GBE accounts for the pleiotropic effects, including antioxidant effects, inhibition of platelet aggregation and thromboxane B2 production, vasodilation and modulation of cholesterol metabolism. Clinically, GBE was widely used in management of vertigo、dementia and improving peripheral circulation. In our previous study, ginkgo biloba extract inhibits tumor necrosis factor-alpha-induced reactive oxygen species generation, transcription factor activation, and cell adhesion molecule expression in human aortic endothelial cells. In addition, the similar benefit of prevention atherosclerosis was also found in animal study. Heme oxygenase-1 (HO-1) is a factor associated with higher risk of developing some vascular disease and also a rate-limiting enzyme in heme degradation, leading to the generation of free iron, biliverdin, and carbon monoxide (CO). CO exerts potent antiproliferative and anti-inflammatory effects in the vascular walls, thereby influencing neointimal formation after vascular injury. In addition, biliverdin is subsequently metabolized to bilirubin by the enzyme biliverdin reductase. Therefore, induction of HO-1 elicits potent anti-inflammatory, antiproliferative, antithrombotic, and antioxidant effects in the circulation via the generation of CO and bilirubin. Interestingly, recent study found that a long guanidine thymidine dinucleotide repeat [(GT) n≧ 30] in the HO-1 promotor, which is linked to impaired inducibility, is associated with a higher frequency of vascular access failure. In the present study, we will investigate the effect of GBE on recovering endothelial dysfunction and inflammation in diabetic patients with stable coronary artery disease. In particularly, we intend to determine whether the GBE modulates the HO-1 expression and investigate whose genotyping including some candidate gene about atherosclerosis and hypertension will have most therapeutic effect of GBE.
NCT01334515 Biological Therapy, Sargramostim, and Isotretinoin in Treating Patients With Relapsed or Refractory Neuroblastoma Completed National Cancer Institute (NCI) Phase 2 This phase II trial is studying how well hu14.18-interleukin-2 (IL2) fusion protein works when given together with sargramostim and isotretinoin in treating patients with relapsed or refractory neuroblastoma. Biological therapy, such as hu14.18-IL2 fusion protein, and sargramostim work in different ways to stimulate the immune system and stop tumor cells from growing. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hu14.18-IL2 fusion protein together with sargramostim and isotretinoin may kill more tumor cells.
NCT01334515 Biological Therapy, Sargramostim, and Isotretinoin in Treating Patients With Relapsed or Refractory Neuroblastoma Completed Children's Oncology Group Phase 2 This phase II trial is studying how well hu14.18-interleukin-2 (IL2) fusion protein works when given together with sargramostim and isotretinoin in treating patients with relapsed or refractory neuroblastoma. Biological therapy, such as hu14.18-IL2 fusion protein, and sargramostim work in different ways to stimulate the immune system and stop tumor cells from growing. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hu14.18-IL2 fusion protein together with sargramostim and isotretinoin may kill more tumor cells.
NCT01595087 A Phase I/II Study of ODX (Osteodex) in Metastatic Castration Resistant Prostate Cancer (CRPC) Completed DexTech Medical AB Phase 1/Phase 2 This phase I/IIa study is a multi-center, prospective, open-label study evaluating safety and biological efficacy of up to six dose levels of Osteodex of patients with metastatic castration resistant prostate cancer (CRPC). Osteodex is a poly-bisphosphonate containing three known substances; dextran, alendronate and guanidine. The objective of the study is to define the maximum tolerable dose of Osteodex when given every third week. The following objectives will also be evaluated: overall survival, PSA response, response markers related to bone metabolism (S-ALP and U-NTx), Quality of Life and assessment of pharmacokinetic parameters.
NCT02378870 A Phase IIb Study to Evaluate Efficacy and Tolerability of ODX (Osteodex) in Metastatic CRPC Terminated DexTech Medical AB Phase 2 This phase IIb study is a randomized, double-blind, placebo-controlled multi-center study evaluating efficacy and tolerability of Osteodex of patients with metastatic castration resistant prostate cancer (CRPC). Osteodex is a poly-bisphosphonate containing three known substances; dextran, alendronate and guanidine. The objective of the study is to evaluate the relative change of response markers to bone metabolism (B-ALP and S-P1NP) The following objectives will also be evaluated: overall survival, PSA response, other response markers related to bone metabolism (S-CTX and osteocalcin), safety, tolerability, pain and quality of life.
NCT02415790 Study to Assess the Safety, Tolerability, Pharmacokinetics of E2027 in Healthy Adult and Elderly Subjects, and the Pharmacodynamics in Healthy Adult Subjects Recruiting Eisai Inc. Phase 1 This first-in-human study, designed to assess the safety, tolerability, and pharmacokinetics (PK) of single oral ascending doses of E2027, will be administered to healthy adult participants to determine the maximum tolerated dose (MTD). Thereafter, the pharmacodynamic (PD) effects of single doses of E2027 on elevation of cerebrospinal fluid (CSF) cyclic guanidine monophosphate (cGMP) in healthy adult participants will be evaluated across a broad dose range, to establish the PK/PD relationship.
NCT02931305 Epimedium Prenylflavonoid (EP) Extract for Osteoporosis and Cardiovascular Disease Recruiting National University Hospital, Singapore Phase 1 The primary objective of the trial is to develop Epimedium Prenylflavonoid (EP) extract as a pharmaceutical-quality intervention for post-menopausal osteoporosis and cardiovascular disease. There will be 3 cohorts of 10 healthy men each for the Phase 1 study. In each cohort, 8 men will receive the Epimedium capsules and 2 men will received the matched controls.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Guanidine Hydrochloride

Condition Name

Condition Name for Guanidine Hydrochloride
Intervention Trials
Prostate Cancer Metastatic 2
Coronary Artery Disease 1
Pediatric Cancer 1
Cardiovascular Disease 1
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Condition MeSH

Condition MeSH for Guanidine Hydrochloride
Intervention Trials
Diabetes Mellitus, Type 2 2
Diabetes Mellitus 2
Prostatic Neoplasms 2
Neuroblastoma 2
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Clinical Trial Locations for Guanidine Hydrochloride

Trials by Country

Trials by Country for Guanidine Hydrochloride
Location Trials
United States 37
Canada 4
Sweden 2
Singapore 1
Taiwan 1
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Trials by US State

Trials by US State for Guanidine Hydrochloride
Location Trials
Missouri 2
Texas 2
California 2
Tennessee 1
Wisconsin 1
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Clinical Trial Progress for Guanidine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Guanidine Hydrochloride
Clinical Trial Phase Trials
Phase 4 1
Phase 2 2
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Guanidine Hydrochloride
Clinical Trial Phase Trials
Completed 2
Not yet recruiting 2
Recruiting 2
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Clinical Trial Sponsors for Guanidine Hydrochloride

Sponsor Name

Sponsor Name for Guanidine Hydrochloride
Sponsor Trials
DexTech Medical AB 2
Children's Oncology Group 1
University of Texas Southwestern Medical Center 1
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Sponsor Type

Sponsor Type for Guanidine Hydrochloride
Sponsor Trials
Other 6
Industry 3
NIH 1
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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Argus Health
Teva
Mallinckrodt
Harvard Business School
Baxter
Deloitte
AstraZeneca
Cipla

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