Clinical trials: Patient Safety
Rheumatoid Arthritis
An Open-label Extension Study of Certolizumab Pegol in Chinese Patients With Rheumatoid Arthritis Who Enrolled in RA0044
This study will continue to evaluate the safety \& efficacy of Certolizumab Pegol (CZP) for 6 months in Chinese subjects with active Rheumatoid Arthritis who participated in RA0044.
- Trial name
- RAPID-C OLE (NCT02319642)
- Testing
- Certolizumab Pegol
- Where
- 30 sites in China
- Volunteers
- 347 people
- Sponsor
- UCB Pharma SA
Prostate Cancer, Hormone Refractory Prostate Cancer
A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer
This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer.
- Trial name
- NCT00510718
- Testing
- MDV3100
- Where
- 9 sites in United States
- Volunteers
- 140 people
- Sponsor
- Pfizer
Peripheral Arterial Disease
Safety and Efficacy Study of a New Intermittent Pneumatic Compression Device to Treat Patients With Peripheral Arterial Disease (PAD) Stage II
The purpose of this study is to evaluate the safety and efficacy of new intermittent pneumatic compression device on initial claudication distance in patients with Peripheral Arterial Disease stage II
- Trial name
- NCT00762086
- Testing
- AngioPress Intermittent pneumatic compression (IPC) Device, Medications and Standard walking exercises
- Where
- 4 sites in Germany, Israel
- Volunteers
- 67 people
- Sponsor
- Mego Afek Ltd.
Type 2 Diabetes
Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin as Monotherapy in Pediatric Patients With Type 2 Diabetes
The purpose of this study is to evaluate the efficacy, safety, tolerability, of Saxagliptin in pediatric patients with type 2 diabetes.
- Trial name
- NCT01204775
- Testing
- Saxagliptin, Metformin IR, Metformin (Active Rescue)
- Where
- 16 sites in United States, Russia and 2 more
- Volunteers
- 26 people
- Sponsor
- AstraZeneca
Pain, Cancer
Long-term Safety Study of Sublingual Fentanyl Tablets in Cancer Patients
The purpose of this study is to evaluate the long-term safety and effectiveness of EN3267 in treating breakthrough pain episodes in opioid cancer patients who are using stable doses of opioid medication.
- Trial name
- NCT00263575
- Testing
- EN3267
- Where
- United States
- Volunteers
- 139 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Diabetes Mellitus, Type 2
Efficacy and Safety of Linagliptin (BI 1356) in Black/African Americans With Type 2 Diabetes With a MTT Sub-study
Study of linagliptin vs. placebo in Black/African American patients with T2DM with a MTT sub-study
- Trial name
- NCT01194830
- Testing
- Linagliptin
- Where
- 93 sites in United States
- Volunteers
- 234 people
- Sponsor
- Boehringer Ingelheim
Kidney Failure, Chronic, Catheter-Related Infections
Study Assessing Safety & Effectiveness of a Catheter Lock Solution in Dialysis Patients to Prevent Bloodstream Infection
The purpose of this study is determine safety and effectiveness of Neutrolin, a catheter lock solution, for prevention of central venous catheter associated bloodstream infection in hemodialysis patients.
- Trial name
- NCT02651428
- Testing
- Neutrolin, Heparin
- Where
- 5 sites in United States
- Volunteers
- 806 people
- Sponsor
- CorMedix Therapeutics
Neovascular Age-Related Macular Degeneration
A Phase III Study to Evaluate the Port Delivery System With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration
Study GR40548 is a Phase III, randomized, multicenter, open-label (visual assessor [VA]-masked), active-comparator study designed to assess the efficacy, safety, and pharmacokinetics (PK) of 100mg/ml delivered via the Port…
- Trial name
- Archway (NCT03677934)
- Testing
- PDS Implant filled with 100 mg/mL Ranibizumab, Intravitreal Injections of 10 mg/mL Ranibizumab
- Where
- 77 sites in United States
- Volunteers
- 415 people
- Sponsor
- Hoffmann-La Roche
Neoplasm
Safety, Preliminary Efficacy and PK of Isatuximab (SAR650984) Alone or in Combination With Atezolizumab in Patients With Advanced Malignancies
Primary Objectives: Phase 1: To characterize the safety and tolerability of isatuximab in combination with atezolizumab in participants with unresectable hepatocellular carcinoma (HCC), platinum-refractory recurrent/metastatic…
- Trial name
- NCT03637764
- Testing
- Isatuximab SAR650984, Atezolizumab
- Where
- 26 sites in United States, Belgium and 6 more
- Volunteers
- 107 people
- Sponsor
- Sanofi
Follicular Lymphoma
GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)
The purpose of this study is to demonstrate comparability of the ORR in patients with previously untreated, advanced stage FL who receive GP2013-treatment to patients who receive MabThera-treatment.
- Trial name
- ASSIST_FL (NCT01419665)
- Testing
- GP2013, rituximab
- Where
- 153 sites in Argentina, Australia and 24 more
- Volunteers
- 629 people
- Sponsor
- Sandoz
Chronic Plaque Psoriasis
A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Adult Patients With Chronic Plaque Psoriasis
This is a study to assess the long-term safety, tolerability, and efficacy of bimekizumab.
- Trial name
- NCT03230292
- Testing
- Bimekizumab
- Where
- 10 sites in United States, Australia and 2 more
- Volunteers
- 43 people
- Sponsor
- UCB Biopharma SRL
Rheumatoid Arthritis
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor
This study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis who have had an inadequate response to one prior anti-TNF alpha inhibitor.
- Trial name
- NCT02079532
- Testing
- rituximab [MabThera]
- Where
- 69 sites in Germany
- Volunteers
- 302 people
- Sponsor
- Hoffmann-La Roche
Renal Cell Carcinoma
Efficacy and Safety Comparison of RAD001 Versus Sunitinib in the First-line and Second-line Treatment of Patients With Metastatic Renal Cell Carcinoma
This study assessed the efficacy and safety of first-line RAD001 followed by second-line sunitinib versus the opposite sequence: first-line sunitinib followed by second-line RAD001 for the treatment of patients with MRCC.
- Trial name
- RECORD-3 (NCT00903175)
- Testing
- everolimus, sunitinib
- Where
- 84 sites in United States, Argentina and 17 more
- Volunteers
- 471 people
- Sponsor
- Novartis Pharmaceuticals
Schizophrenia
Multicenter, Open-label, Safety and Tolerability Study
This will be a multicenter, 52 week, open label study to assess the safety and tolerability of oral OPC-34712 (1 to 6 mg) as monotherapy in adult patients with schizophrenia. The study will be conducted on an outpatient basis.
- Trial name
- STEP 210 (NCT01649557)
- Testing
- OPC-34712
- Where
- 68 sites in United States, Bulgaria and 10 more
- Volunteers
- 244 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Rheumatoid Arthritis
A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment (STAGE)
This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in combination with methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate.
- Trial name
- STAGE (NCT00406419)
- Testing
- Methotrexate, ocrelizumab
- Where
- United States
- Volunteers
- 1,015 people
- Sponsor
- Genentech, Inc.
Pancreatic Cancer
Study of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cy) in Patients With Pancreatic Cancer
The purpose of this study is to study the safety and clinical activity of nivolumab and ipilimumab in combination with either sequential administration of CY/GVAX pancreas vaccine followed by CRS-207 (Arm A) or with…
- Trial name
- NCT03190265
- Testing
- Cyclophosphamide, Nivolumab, Ipilimumab
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Cystic Fibrosis
Safety/Tolerability Study of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa
This is a study to determine the safety and tolerability of 28 days of daily dosing of 560 mg of Arikayce™ versus placebo and daily dosing of 70 mg and 140 mg of Arikayce™ versus placebo in patients who have Cystic fibrosis (CF)…
- Trial name
- NCT00558844
- Testing
- Arikayce™ 560 mg, Arikayce™ 70 mg, Arikayce™ 140 mg
- Where
- 19 sites in United States
- Volunteers
- 41 people
- Sponsor
- Insmed Incorporated
Macular Degeneration
Treat & Extend Treatment With 0.5mg Ranibizumab vs Monthly Treatment With 0.5mg Ranibizumab
TREX is a phase IIIb, multicenter, randomized, controlled clinical study. Subjects will be randomized 1:2 to "monthly" (control arm) or "treat and extend" protocol (comparator arm) respectively.
- Trial name
- T-REX (NCT01748292)
- Testing
- 0.5 mg ranibizumab
- Where
- 4 sites in United States
- Volunteers
- 60 people
- Sponsor
- Charles C Wykoff, PhD, MD
Primary Open Angle Glaucoma, Ocular Hypertension
Clinical Study of A Fixed Combination of Timolol-Brimonidine-Dorzolamide
To compare intraocular pressure lowering effectiveness of a new fixed combination drug.
- Trial name
- NCT01062971
- Testing
- dorzolamide-timolol-brimonidine
- Where
- Mexico
- Volunteers
- 124 people
- Sponsor
- Laboratorios Sophia S.A de C.V.
Atopic Dermatitis
Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis
This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of…
- Trial name
- ADvocate2 (NCT04178967)
- Testing
- Lebrikizumab
- Where
- 89 sites in United States, Bulgaria and 6 more
- Volunteers
- 445 people
- Sponsor
- Eli Lilly and Company
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