Clinical trials: Patient Safety
Type 2 Diabetes Mellitus
Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes
The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with oral antihyperglycaemic agent in patients with type 2 Diabetes for 52 weeks administration.
- Trial name
- NCT01301833
- Testing
- teneligliptin, glinide, biguanide
- Where
- Japan
- Volunteers
- 462 people
- Sponsor
- Tanabe Pharma Corporation
Renal Transplantation
Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients.
- Trial name
- NCT00400400
- Testing
- Enteric-coated mycophenolate sodium (EC-MPS), Mycophenolate mofetil
- Where
- 53 sites in United States
- Volunteers
- 400 people
- Sponsor
- Novartis Pharmaceuticals
Bloodstream Infections (BSI) Due to CRE, Hospital-Acquired Bacterial Pneumonia (HABP) Due to CRE
A Study of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (CRE)
This was a Phase 3 study containing a randomized open-label superiority cohort (Cohort 1) comparing the efficacy and safety of plazomicin with colistin when combined with a second antibiotic (either meropenem or tigecycline) in…
- Conditions
- Bloodstream Infections (BSI) Due to CRE, Hospital-Acquired Bacterial Pneumonia (HABP) Due to CRE, Ventilator-Associated Bacterial Pneumonia (VABP) Due to CRE, Complicated Urinary Tract Infection (cUTI) Due to CRE
- Trial name
- CARE (NCT01970371)
- Testing
- plazomicin, colistin, meropenem
- Volunteers
- 69 people
- Sponsor
- Achaogen, Inc.
Arthritis, Psoriatic, Psoriasis
Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Dermatologists
The purpose of this study is to evaluate the safety profile and the effectiveness of etanercept under usual care settings in patients with PsA treated by dermatologists.
- Conditions
- Arthritis, Psoriatic, Psoriasis, Skin Diseases, Papulosquamous
- Trial name
- NCT00293709
- Testing
- etanercept
- Where
- Germany
- Volunteers
- 129 people
- Sponsor
- Pfizer
Still's Disease, Adult-Onset, Still's Disease, Juvenile-Onset
A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Still's Disease (SJIA and AOSD)
The aim of this study is to demonstrate the efficacy and to evaluate the safety, pharmacokinetics (PK) and immunogenicity of anakinra in patients with newly diagnosed Still's disease, including SJIA (Systemic juvenile idiopathic…
- Trial name
- anaSTILLs (NCT03265132)
- Testing
- anakinra
- Where
- 39 sites in United States, Canada
- Volunteers
- 13 people
- Sponsor
- Swedish Orphan Biovitrum
Perennial Allergic Rhinoconjunctivitis, House Dust Mite Allergy
A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis
The purpose of the study is to test the efficacy of the combination treatment AllQbG10 in patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a double-blind, placebo-controlled setting
- Trial name
- NCT00574704
- Testing
- CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)
- Volunteers
- 40 people
- Sponsor
- Cytos Biotechnology AG
Neovascular Age-related Macular Degeneration (nAMD)
Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Vial Kit
This is a single-arm, open-label study where all patients will receive a single injection of SOK583A1 (40 mg/mL) provided in a vial kit at Baseline. The total study duration for the individual participant is approximately 31 days.
- Trial name
- NCT05282004
- Testing
- SOK583A1
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- Sandoz
Fabry Disease
A 24-Week Safety and Pharmacodynamic Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease
Study to evaluate the safety, tolerability, and pharmacodynamics of migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease.
- Trial name
- NCT00283933
- Testing
- migalastat HCl
- Where
- 2 sites in France, United Kingdom
- Volunteers
- 5 people
- Sponsor
- Amicus Therapeutics
Non-Alcoholic Steatohepatitis (NASH)
Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH)
Abdominal obesity and type-2 Diabetes are associated with chronic liver disorders resulting from the accumulation of fat in the liver (steatosis), which may progress towards hepatitis and possibly lead to cirrhosis and liver…
- Trial name
- NCT01694849
- Testing
- GFT505 80mg, GFT505 120mg
- Where
- 56 sites in United States, Belgium and 7 more
- Volunteers
- 275 people
- Sponsor
- Genfit
Secondary Hyperparathyroidism, End-Stage Renal Disease
Study to Evaluate Safety of Vitamin D Receptor Activators in Patients Ages 0 to 16 With Chronic Kidney Disease Stage 5 Receiving Peritoneal Dialysis Within Current Clinical Practice
The objective of this study was to observe the safety of paricalcitol utilization in pediatric participants (ages 0 to 16 years old) being treated for secondary hyperparathyroidism (SHPT).
- Trial name
- NCT01134315
- Testing
- Paricalcitol, Calcitriol
- Where
- 18 sites in United States
- Volunteers
- 61 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Basal Cell Carcinoma
A Study Evaluating the Efficacy and Safety of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) in Patients With Advanced Basal Cell Carcinoma
This is a Phase II, single-arm, two-cohort multicenter clinical trial evaluating the efficacy and safety of vismodegib (GDC-0449) in patients with advanced basal cell carcinoma.
- Trial name
- NCT00833417
- Testing
- Vismodegib 150 mg
- Where
- 36 sites in United States, Australia and 4 more
- Volunteers
- 104 people
- Sponsor
- Genentech, Inc.
Chronic Lymphocytic Leukemia
FCM-R (Fludarabine, Cyclophosphamide, Mitoxantrone, Rituximab) in Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL) < 70 Years
The goal of this clinical research study is to learn if using a combination of fludarabine, cyclophosphamide, and mitoxantrone plus rituximab, with the growth factor pegylated filgrastim, will improve the response to treatment…
- Trial name
- NCT00254410
- Testing
- Fludarabine, Cyclophosphamide, Mitoxantrone
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- M.D. Anderson Cancer Center
Schizophrenia
Paliperidone Extended Release(ER) Effectiveness Study to Evaluate the Objective Symptom Change and Symptomatic Remission
The purpose of this study is to investigate the safety and efficacy of flexibly dosed paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment…
- Trial name
- PERFECT (NCT00761579)
- Testing
- Paliperidone
- Where
- 8 sites in South Korea
- Volunteers
- 190 people
- Sponsor
- Janssen Korea, Ltd., Korea
Rheumatoid Arthritis
Efficacy, Safety and Tolerability of ACZ885 in Patients With Active Rheumatoid Arthritis
The 12-week core study was designed to evaluate risk-benefit of three subcutaneous dose regimens of ACZ885, added on to stable methotrexate (MTX) therapy (greater than or equal to 7.5 mg/week), compared to placebo in patients…
- Trial name
- NCT00424346
- Testing
- Canakinumab
- Where
- 17 sites in United States, Austria and 4 more
- Volunteers
- 274 people
- Sponsor
- Novartis
Hereditary Inclusion Body Myopathy, Distal Myopathy With Rimmed Vacuoles
Study to Evaluate the Safety and Efficacy of Aceneuramic Acid Extended-Release (Ace-ER) Tablets in Patients With Glucosamine (UDP-N-acetyl)-2-epimerase Myopathy (GNEM) or Hereditary Inclusion Body Myopathy (HIBM)
The objective of this study is to evaluate the long-term safety and efficacy of Ace-ER treatment in subjects with GNEM.
- Conditions
- Hereditary Inclusion Body Myopathy, Distal Myopathy With Rimmed Vacuoles, Distal Myopathy, Nonaka Type, GNE Myopathy
- Trial name
- NCT02736188
- Testing
- Aceneuramic Acid Extended-Release Tablets
- Where
- 14 sites in United States, Bulgaria and 5 more
- Volunteers
- 143 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Carcinoma, Hepatocellular, Gastric/Gastroesophageal Junction Cancer
A Study to Investigate Sitravatinib as Monotherapy and in Combination With Tislelizumab in Participants With Unresectable Locally Advanced or Metastatic Hepatocellular Carcinoma or Gastric/Gastroesophageal Junction Cancer
The purpose of this study was to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of sitravatinib as monotherapy and in combination with tislelizumab in participants with unresectable locally…
- Trial name
- NCT03941873
- Testing
- Sitravatinib, Tislelizumab
- Where
- 18 sites in China
- Volunteers
- 111 people
- Sponsor
- BeiGene
Rheumatoid Arthritis
A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs)
This observational study will evaluate the safety and efficacy of tocilizumab in participants with active moderate to severe RA and an inadequate response to non-biologic DMARDs.
- Trial name
- NCT01617005
- Testing
- Tocilizumab
- Where
- Montenegro
- Volunteers
- 50 people
- Sponsor
- Hoffmann-La Roche
Stem Cell Transplantation, Ventricular Dysfunction, Left
The Transendocardial Autologous Cells (hMSC or hBMC) in Ischemic Heart Failure Trial (TAC-HFT)
The technique of transplanting progenitor cells into a region of damaged myocardium, termed cellular cardiomyoplasty, is a potentially new therapeutic modality designed to replace or repair necrotic, scarred, or dysfunctional…
- Trial name
- TAC-HFT (NCT00768066)
- Testing
- Autologous human mesenchymal cells (hMSCs), Autologous human bone marrow cells (hBMCs)
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- University of Miami
Metastatic Renal Cell Carcinoma
RAD001 Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed After Treatment With Sorafenib and/or Sunitinib
To assess whether daily treatment with RAD001 could slow the growth and spread of metastatic carcinoma of the kidney. The safety of RAD001 was also to be studied in this trial.
- Trial name
- RECORD-1 (NCT00410124)
- Testing
- RAD001
- Where
- 93 sites in United States, Australia and 8 more
- Volunteers
- 416 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Malignancies, Advanced Cancer
Study of ASP7517 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Expressing WT1 Antigen
The purpose of this study was to evaluate the safety, tolerability, and clinical response of ASP7517, and determine the Recommended Phase 2 Dose (RP2D) and/or the Maximum Tolerated Dose (MTD) of ASP7517 when administered as a…
- Trial name
- NCT04837196
- Testing
- ASP7517, Pembrolizumab
- Where
- 4 sites in United States
- Volunteers
- 24 people
- Sponsor
- Astellas Pharma Global Development, Inc.
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