Clinical trials: Patient Safety
Chronic Lymphocytic Leukemia, Hypogammaglobulinemia
Double-blind, Randomized, Placebo-controlled, Prospective Phase III Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients With Chronic Lymphocytic Leukemia ("PRO-SID" Study)
Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients with Chronic Lymphocytic Leukemia
- Trial name
- NCT04502030
- Testing
- Panzyga
- Where
- 84 sites in United States, Czechia and 10 more
- Volunteers
- 247 people
- Sponsor
- Octapharma
Locally Advanced or Metastatic Non Small Cell Lung Cancer
Study to Evaluate Safety, Pharmacokinetics, and Efficacy of Rociletinib (CO-1686) in Previously Treated Mutant Epidermal Growth Factor Receptor (EGFR) in Non-Small Cell Lung Cancer (NSCLC) Patients
Rociletinib is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI) that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing wild-type (WT) EGFR.
- Trial name
- NCT01526928
- Testing
- Rociletinib
- Where
- 49 sites in United States, Australia and 2 more
- Volunteers
- 612 people
- Sponsor
- Clovis Oncology, Inc.
Hypertension
A Study to Investigate the Magnitude and Duration of Response of MK0954 Compared to Placebo in Patients With Hypertension (0954-021)(COMPLETED)
The purpose of this study was to evaluate the magnitude and durations of the antihypertensive effects of losartan using ambulatory blood pressure monitoring (ABPM), and to evaluate the safety of losartan 50 and 100 mg doses…
- Trial name
- NCT00886600
- Testing
- losartan potassium, hydrochlorothiazide (HCTZ)
- Volunteers
- 122 people
- Sponsor
- Merck Sharp & Dohme LLC
Major Depressive Disorder (MDD)
Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)
This will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in participants with MDD who have demonstrated an…
- Trial name
- NCT01111565
- Testing
- Escitalopram, Aripiprazole
- Where
- 53 sites in United States, Canada and 9 more
- Volunteers
- 137 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Safety, Pharmacokinetics and Efficacy Study of MP-214 in Patients With Schizophrenia
The purpose of this study is to assess the safety, pharmacokinetics and efficacy of 3 fixed doses of MP-214 orally administered once daily to patients with schizophrenia.
- Trial name
- NCT00862992
- Testing
- Cariprazine 3 mg, Cariprazine 6 mg, Cariprazine 12.5 mg
- Where
- Japan
- Volunteers
- 34 people
- Sponsor
- Tanabe Pharma Corporation
Diabetes Mellitus, Type 2
4 Week Treatment With Three Oral Doses of BI 10773 in Patients With Type 2 Diabetes
Primary objective: safety and tolerability of BI 10773 in male and female patients with type 2 diabetes Secondary objective: pharmacokinetics and pharmacodynamics of BI 10773
- Trial name
- NCT00558571
- Testing
- BI 10773 low dose, BI 10773 medium dose, BI 10773 high dose
- Where
- 3 sites in Germany
- Volunteers
- 78 people
- Sponsor
- Boehringer Ingelheim
Cystic Fibrosis
MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to…
- Trial name
- NCT01180634
- Testing
- Aeroquin
- Where
- 112 sites in United States, Australia and 3 more
- Volunteers
- 330 people
- Sponsor
- Amgen
Acromegaly
An Extension Study to Assess the Long-Term Safety and Efficacy of Pasireotide in Participants With Acromegaly
Acromegaly is a rare, serious condition characterized by chronic hypersecretion of growth hormone (GH), generally caused by a GH-secreting pituitary adenoma.
- Trial name
- NCT00171730
- Testing
- Pasireotide
- Where
- 10 sites in United States, Australia and 5 more
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Diseases
Study of ISA247 (Voclosporin) in De Novo Renal Transplantation
This study will see if voclosporin is safe and effective in preventing kidney transplant rejection.
- Trial name
- PROMISE (NCT00270634)
- Testing
- Voclosporin, tacrolimus
- Where
- 45 sites in United States, Canada
- Volunteers
- 334 people
- Sponsor
- Aurinia Pharmaceuticals Inc.
HIV Infections, Acquired Immunodeficiency Syndrome
Safety and Efficacy of an Investigational Drug in Human Immunodeficiency Virus (HIV)-Infected Patients Failing Current Antiretroviral Therapies (0518-005)(COMPLETED)
This study will investigate the safety and efficacy of different doses of an investigational drug (MK0518) as a therapy for HIV-infected patients failing current antiretroviral therapies.
- Trial name
- NCT00105157
- Testing
- Comparator: MK0518, MK0518
- Volunteers
- 179 people
- Sponsor
- Merck Sharp & Dohme LLC
Advanced Solid Tumors
Effects of Fluconazole and Itraconazole CYP3A-Mediated Inhibition on the Pharmacokinetics, Safety, and Tolerability of MLN4924 in Participants With Advanced Solid Tumors
The primary purpose of this study is to assess the effect of multiple-dose administration of fluconazole on the single-dose intravenous (IV) pharmacokinetics (PK) of MLN4924; and to assess the effect of multiple-dose…
- Trial name
- NCT02122770
- Testing
- MLN4924, Fluconazole, Itraconazole
- Where
- 4 sites in United States
- Volunteers
- 51 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Immune Thrombocytopenia
Long-term Study of Romiplostim in Thrombocytopenic Pediatric Patients With Immune Thrombocytopenia (ITP)
This is a phase 3b single arm, open label, multicenter study describing the percentage of time pediatric participants with ITP have a platelet response while receiving romiplostim, defined as a platelet count ≥ 50 x 10^9/L in the…
- Trial name
- NCT02279173
- Testing
- Romiplostim
- Where
- 78 sites in United States, Australia and 15 more
- Volunteers
- 203 people
- Sponsor
- Amgen
Carcinoma, Non-Small-Cell Lung
Study to Test the Safety and How Radium-223 Dichloride an Alpha Particle-emitting Radioactive Agent Works in Combination With Pembrolizumab an Immune Checkpoint Inhibitor in Patients With Stage IV Non-small Cell Lung Cancer With Bone Metastases
The purpose of the study was to determine the safety and test the efficacy of the combination of radium-223 dichloride and pembrolizumab in patients with stage IV non-small cell lung cancer (NSCLC) with bone metastases who either…
- Trial name
- NCT03996473
- Testing
- Radium-223 dichloride (Xofigo, BAY 88-8223), Pembrolizumab
- Where
- 6 sites in United States, Belgium and 2 more
- Volunteers
- 8 people
- Sponsor
- Bayer
Osteoarthritis
Randomized Study of the Efficacy and Safety of a Single Dose of Synvisc-One® in Chinese Patients With Symptomatic Osteoarthritis of the Knee
Primary Objective: -To evaluate the efficacy of a single 6-milliliter (mL) intra-articular (IA) injection of Hylan G-F 20 measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numerical Rating Scale…
- Trial name
- C-SOUND (NCT03190369)
- Testing
- Hylan G-F 20 (GZ402662/SAR402662)
- Where
- 21 sites in China
- Volunteers
- 440 people
- Sponsor
- Genzyme, a Sanofi Company
Neovascular Age-related Macular Degeneration
Safety, Tolerability, and Efficacy Study of UBX1325 in Patients With Neovascular Age-Related Macular Degeneration (ENVISION)
This study is intended to assess safety, tolerability and biological activity of a repeat IVT injection of UBX1325 in patients with wet AMD.
- Trial name
- NCT05275205
- Testing
- UBX1325 injection 50 μL, EYLEA® (aflibercept) Injection 2 mg (0.05mL)
- Where
- 14 sites in United States
- Volunteers
- 51 people
- Sponsor
- Unity Biotechnology, Inc.
Melanoma
Phase II Study to Assess the Safety and Immunogenicity of recMAGE-A3+AS15 ASCI With or Without Poly IC:LC
The overall purpose of this research study is to find a better way to treat melanoma. The goals of this study are: 1. To measure the side effects of and find out how well patients tolerate the recMAGE-A3 + AS15 ASCI (MAGE-A3…
- Trial name
- NCT01437605
- Testing
- MAGE-A3 ASCI injections without Poly IC:LC, MAGE-A3 ASCI injections with Poly IC:LC
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Osteoarthritis
An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Participants With Osteoarthritis
The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic System (TTS)-fentanyl patch (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the…
- Trial name
- NCT01774929
- Testing
- TTS-fentanyl
- Where
- Thailand
- Volunteers
- 35 people
- Sponsor
- Janssen-Cilag Ltd.,Thailand
Portal Hypertension
Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension
The primary purpose of this study is to determine the efficacy and safety of cobiprostone (at two dose levels) as compared to placebo for lowering portal hypertension.
- Trial name
- NCT00737594
- Testing
- Cobiprostone
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Sucampo Pharma Americas, LLC
Osteogenesis Imperfecta
Post-market Observational Study on JTIN Telescopic Nail in Osteogenesis Imperfecta Pediatric Patients
This study has been planned as part of the Orthofix Srl post-market active surveillance plan for the collection of data on both the clinical performance and the safety profile of the JTIN.
- Trial name
- JTIN (NCT05612139)
- Testing
- JTIN implantation surgery
- Where
- France
- Volunteers
- 14 people
- Sponsor
- Orthofix s.r.l.
Major Depressive Disorder (MDD)
Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)
This will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in participants with MDD who have demonstrated an…
- Trial name
- NCT01111539
- Testing
- Escitalopram, Aripiprazole, Blinded capsule
- Where
- 62 sites in United States, Estonia and 7 more
- Volunteers
- 211 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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