Clinical trials: de Novo
Kidney Transplantation
Efficacy and Safety of AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Steroids in Preventing Acute Rejection After Kidney Transplantation
Efficacy and safety of AEB071 in combination with mycophenolate acid sodium, basiliximab and steroids in preventing acute rejection after kidney transplantation.
- Trial name
- NCT00492869
- Testing
- AEB071
- Where
- 41 sites in United States, Belgium and 5 more
- Volunteers
- 124 people
- Sponsor
- Novartis Pharmaceuticals
Coronary Artery Disease
Study of the Orsiro Drug Eluting Stent System
The purpose of this study is to compare the BIOTRONIK Orsiro Drug Eluting Stent System with the Abbott Xience Prime™ Drug Eluting Stent System with respect to in-stent Late Lumen Loss in a non-inferiority study in de novo…
- Trial name
- BIOFLOW-II (NCT01356888)
- Testing
- Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES), Percutaneous Coronary Intervention (Orsiro DES)
- Where
- 24 sites in Austria, France and 6 more
- Volunteers
- 452 people
- Sponsor
- Biotronik AG
Diffuse Large Cell B-lymphoma
Safety and Efficacy Study of a BTK Inhibitor in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma
The purpose of this study is to evaluate the efficacy of ibrutinib (PCI-32765) in relapsed/refractory de novo activated B-cell (ABC) and germinal-cell B-Cell (GCB) Diffuse Large B-cell Lymphoma (DLBCL).
- Trial name
- NCT01325701
- Testing
- ibrutinib
- Where
- 15 sites in United States
- Volunteers
- 78 people
- Sponsor
- Pharmacyclics LLC.
Leukemia, Myelodysplastic Syndromes
VNP40101M in Treating Patients With Acute Myelogenous Leukemia or High-Risk Myelodysplasia
RATIONALE: Drugs used in chemotherapy, such as VNP40101M and hydroxyurea, work in different ways to stop cancer cells from dividing so they stop growing or die.
- Conditions
- Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
- Trial name
- NCT00083187
- Testing
- hydroxyurea, laromustine
- Where
- 5 sites in United States, France and 1 more
- Volunteers
- 230 people
- Sponsor
- Vion Pharmaceuticals
de Novo Stenotic Lesions in Native Coronary Arteries
NIRTRAKS Post-Market Study (NIRTRAKS)
This is a prospective, post-marketing, non-randomized, multi-center, single-arm clinical study that will be conducted at up to 15 sites in the United States (US).
- Trial name
- NIRTRAKS (NCT02455804)
- Testing
- Stenting procedure
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Medinol Ltd.
Heart Transplantation
Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Comparison to Mycophenolate Mofetil (MMF) in de Nove Heart Patients
This study will evaluate the safety and efficacy of EC-MPS (ERL080) in comparison to MMF in de novo heart recipients.
- Trial name
- NCT00574743
- Testing
- Enteric-coated Mycophenolate Sodium
- Where
- 9 sites in United States, Argentina and 2 more
- Volunteers
- 162 people
- Sponsor
- Novartis Pharmaceuticals
de Novo Kidney Transplant Recipients, Renal Transplantation
Once-a-day Regimen With Everolimus, Low Dose Cyclosporine and Steroids in Comparison With Steroid Withdrawal or Twice a Day Regimen With Everolimus, Low Dose Cyclosporine and Steroids.
This study will compare the following immunosuppressive regimens in recipients of kidney transplantation: A) everolimus, cyclosporine and steroids given once-a-day; B) everolimus and cyclosporine given twice a day with steroid…
- Trial name
- EVIDENCE (NCT01023815)
- Testing
- everolimus, cyclosporine, Prednison (continuous steroids)
- Where
- 28 sites in Italy
- Volunteers
- 330 people
- Sponsor
- Novartis
Coronary Artery Disease
Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus-eluting Stent
BIOFLOW-IV is a prospective, international, multicenter, randomised controlled trial. The purpose of this trial is to compare the Biotronik Orsiro drug eluting stent system with the Xience Prime / Xience Xpedition (Xience)drug…
- Trial name
- BIOFLOW-IV (NCT01939249)
- Testing
- Abbott Laboratories Xience, Biotronik Orsiro
- Where
- 45 sites in Australia, Belgium and 10 more
- Volunteers
- 585 people
- Sponsor
- Biotronik AG
Schizophrenia
An Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-5)
This is a Phase 3, multicenter, 56-week, outpatient, open-label (OL) study to evaluate the long-term safety, tolerability, and efficacy of KarXT in de novo subjects with Diagnostic and Statistical Manual-Fifth Edition (DSM-5)…
- Trial name
- NCT04820309
- Testing
- Xanomeline and Trospium Chloride Capsules
- Where
- 117 sites in United States, Puerto Rico
- Volunteers
- 566 people
- Sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
With de Novo or Restenotic Lesions in the Common and/or External Iliac Arteries
Comparative Study Of Safety And Efficacy Of The SUPERA® Nitinol Stent - Iliac Artery
This is a prospective, multicenter, non-randomized, single-arm trial; the primary objective is to assess the comparability of the performance of the IDev SUPERA® nitinol stent to a rate derived from a meta-analysis of studies on…
- Trial name
- I-WIN (NCT00613418)
- Testing
- IDev SUPERA® Interwoven Self Expanding Nitinol Stent Peripheral Vascular System
- Sponsor
- Abbott Medical Devices
Peripheral Arterial Disease
CVI Drug Coated Balloon First In Human Trial
The purpose of this study is to assess safety and the inhibition of restenosis of the CVI Paclitaxel-coated PTA Balloon Catheter in the treatment of de-novo occluded/stenotic or reoccluded/restenotic superficial femoral (SFA) or…
- Trial name
- NCT02110524
- Testing
- Percutaneous Transluminal Angioplasty
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- Spectranetics Corporation
Myelodysplastic Syndromes (MDS)
A Phase 1b/2 Study of Alvocidib Plus Decitabine or Azacitidine in Patients With MDS
Alvocidib, a cyclin-dependent kinase 9 (CDK 9) inhibitor, in time-sequential therapy demonstrated significant clinical activity in secondary AML patients with prior MDS.
- Trial name
- NCT03593915
- Testing
- Alvocidib Plus Decitabine (during dose escalation only) or Azacitidine
- Where
- 12 sites in United States
- Volunteers
- 20 people
- Sponsor
- Sumitomo Pharma America, Inc.
Coronary Artery Disease
Prevail Global Study
The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.
- Trial name
- NCT06535854
- Testing
- Prevail DCB, Agent DCB
- Where
- 79 sites in United States, Canada and 7 more
- Volunteers
- 1,205 people
- Sponsor
- Medtronic Vascular
Coronary Artery Disease
The CYPHER™ Stent Study in Patients With Small de Novo Coronary Artery Lesions.
The main objective of this study is to assess the effectiveness of the CYPHER™ (sirolimus-eluting) stent in reducing in-lesion late lumen loss in de novo native coronary artery lesions in small vessels (2.25 - 2.75 mm) as…
- Trial name
- SVELTE (NCT00235066)
- Testing
- PCI
- Where
- Switzerland
- Volunteers
- 100 people
- Sponsor
- Cordis US Corp.
Coronary Artery Disease
Study Safety and Performance of the Biomime Stent in Patients With Single, De Novo, Non-Complex Coronary Lesions
1.) Indigenously developed and designed BioMimeTM is a predictably safe \& efficacious 3rd generation drug eluting stent (DES) with a propensity to minimize vascular injury by use of an intelligent mix of ultra-low strut…
- Trial name
- meriT-1 (NCT01507519)
- Testing
- Sirolimus Eluting Coronary Stent System (Biomime)
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Meril Life Sciences Pvt. Ltd.
Kidney Transplantation
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients
This study was to compare CFZ533 to tacrolimus (TAC) in prevention of organ rejection in kidney transplant.
- Trial name
- CIRRUS I (NCT03663335)
- Testing
- CFZ533 - Cohort 1/Cohort 2, Mycophenolate Mofetil (MMF), Corticosteroids (CS)
- Where
- 74 sites in United States, Argentina and 18 more
- Volunteers
- 418 people
- Sponsor
- Novartis Pharmaceuticals
Bone Marrow Transplantation, Graft Versus Host Disease
A Study to Assess Efficacy, Safety and Pharmacokinetics of a Tacrolimus New Oral Formulation (MR4) in BMT Recipients
A study to assess efficacy, safety and pharmacokinetics of a tacrolimus new oral formulation (MR4) in de novo bone marrow transplant recipients
- Conditions
- Bone Marrow Transplantation, Graft Versus Host Disease, Graft-Vs-Host Disease, Graft-Versus-Host Disease
- Trial name
- NCT00189761
- Testing
- Tacrolimus
- Where
- 4 sites in Japan
- Sponsor
- Astellas Pharma Inc
Cancer
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.
- Trial name
- NCT00538850
- Testing
- Fentanyl sublingual spray
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- INSYS Therapeutics Inc
Hypertension
Comparison of Two Treatment Strategies in Hypertensive Patients
The purpose of the study is to determine whether a specific training of General Practitioners (Family Physicians) regarding the new official guidelines for the treatment of hypertension results in a higher control of high Blood…
- Trial name
- NCT00171444
- Testing
- Medical education
- Volunteers
- 4,445 people
- Sponsor
- Novartis
Coronary Atherosclerosis of Native Coronary Artery, Bifurcation Lesions: de Novo Lesions of the Main and Side Branch of Native Coronary Artery
Prospective, Single Blind, Rand Controlled Study to Evaluate the Safety & Effectness of Tryton Side Branch Stent Used With DES Treatmt of de Novo Bifurcation Lesions in MB & SB in Native Coronaries
The Tryton Side Branch Stent System has been designed to address the procedural difficulty surrounding treatment of bifurcation lesions and to ensure patency of the side branch with similar performance capabilities (e.g.…
- Trial name
- TRYTON (NCT01258972)
- Testing
- Tryton Side Branch Stent with main branch DES, POBA
- Where
- United States
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- Tryton Medical, Inc.