Clinical trials: Patient Safety
Asthma
Efficacy and Safety Study of Fluticasone Proponate Inhalation Solution in Adult and Adolescent Asthma
This is a multicentre, randomized, single-blind, active-controlled, parallel-group phase III local registration study for a treatment period of 12 weeks.
- Trial name
- NCT01687283
- Testing
- fluticasone propionate inhalation solution, budesonide suspension
- Where
- 25 sites in China
- Volunteers
- 316 people
- Sponsor
- GlaxoSmithKline
Rheumatoid Arthritis
Open Label Extension for Patients Coming From the Dosing Flexibility Study in Patients With Rheumatoid Arthritis (RA)
The purpose of this study is to continue to assess the safety of certolizumab pegol in combination with methotrexate (MTX).
- Trial name
- Dose Flex II (NCT00753454)
- Testing
- Certolizumab pegol
- Where
- 40 sites in United States, Canada
- Volunteers
- 168 people
- Sponsor
- UCB Pharma
Psoriasis
International Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of BCD-085 in Various Doses in Patients With Moderate to Severe Plaque Psoriasis
BCD-085-2 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal antibody to interleukin 17. During BCD-085-2 trial patients with moderate to severe plaque psoriasis, in whom poor response to previous…
- Trial name
- NCT02762994
- Testing
- BCD-085
- Where
- Russia
- Volunteers
- 120 people
- Sponsor
- Biocad
Chronic Obstructive Pulmonary Disease
Safety and Efficacy of Multiple Doses of Canakinumab (ACZ885) in Chronic Obstructive Pulmonary Disease (COPD) Patients
Was to evaluate the safety, tolerability and efficacy of multiple doses of canakinumab (ACZ885) vs. placebo when administered via intravenous infusion (IV), on pulmonary function in patients with COPD
- Trial name
- NCT00581945
- Testing
- Canakinumab
- Where
- 11 sites in United States
- Volunteers
- 147 people
- Sponsor
- Novartis
Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder
A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study)
The objectives of this time-to-event study were to assess the efficacy and safety of eculizumab as compared with placebo in participants with neuromyelitis optica spectrum disorder (NMOSD) who were anti-aquaporin-4 (AQP4)…
- Trial name
- NCT01892345
- Testing
- Eculizumab
- Where
- 70 sites in United States, Argentina and 16 more
- Volunteers
- 143 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hepatitis C, Chronic
A Phase III Study of TMC435 in Treatment-naive, Genotype 1, Hepatitis C-infected Patients
The purpose of this study is to evaluate the efficacy and safety of TMC435 compared with placebo in combination with peginterferon alfa-2a (pegIFN alfa-2a) and ribavirin in treatment-naive patients with chronic genotype 1…
- Trial name
- NCT01292239
- Testing
- TMC435, Peginterferon alfa-2a (pegIFN alfa-2a), Ribavirin (RBV)
- Where
- 28 sites in Japan
- Volunteers
- 183 people
- Sponsor
- Janssen Pharmaceutical K.K.
PTSD
12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients
This is an open-label, extension trial designed to evaluate safety over 12 additional weeks of TNX-102 SL therapy taken daily at bedtime for the treatment of PTSD.
- Trial name
- NCT03110575
- Testing
- TNX-102 SL
- Where
- 32 sites in United States
- Volunteers
- 190 people
- Sponsor
- Tonix Pharmaceuticals, Inc.
Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors
This study will test how well a new medicine called concizumab works in the body of people with haemophilia A or B with inhibitors. The purpose is to show that concizumab can prevent bleeds in the body and is safe to use.
- Trial name
- explorer7 (NCT04083781)
- Testing
- Concizumab
- Where
- 99 sites in United States, Algeria and 27 more
- Volunteers
- 134 people
- Sponsor
- Novo Nordisk A/S
Pertrochanteric Fracture of Femur, Intertrochanteric Fracture of Femur
Retrospective Study Chimaera Long Nail in Adult Patient
The CHIMERA study intends to evaluate the clinical benefits of the study medical device in the standard clinical practice.
- Conditions
- Pertrochanteric Fracture of Femur, Intertrochanteric Fracture of Femur, Subtrochanteric Fracture of Femur
- Trial name
- NCT06285981
- Testing
- Chimaera Long Nail
- Where
- 2 sites in Italy
- Volunteers
- 44 people
- Sponsor
- Orthofix s.r.l.
Pemphigus Vulgaris
A Study of PRN1008 in Adult Patients With Pemphigus Vulgaris
Open-label cohort study in adult patients with newly diagnosed or relapsing pemphigus vulgaris, with intra-patient dose-adjustment based on clinical response and BTK occupancy, and with conventional immunosuppressive "rescue…
- Trial name
- NCT02704429
- Testing
- PRN1008
- Where
- 13 sites in Australia, Croatia and 3 more
- Volunteers
- 42 people
- Sponsor
- Principia Biopharma, a Sanofi Company
Persistent or Permanent Nonvalvular Atrial Fibrillation
Long-term Safety in Atrial Fibrillation Patients
The purpose of this study is to provide safety and tolerability data for AZD0837 during long-term treatment (5 years) in patients with non-valvular atrial fibrillation (AF) and one or more additional risk factors for stroke and…
- Trial name
- NCT00645853
- Testing
- AZD0837, VKA INR 2-3
- Volunteers
- 523 people
- Sponsor
- AstraZeneca
Asthma
Crossover Study to Evaluate the Efficacy, Safety and Tolerability of Different Doses of Indacaterol in Patients With Persistent Asthma
The purpose of this study is to determine the efficacy of indacaterol 55µg once daily (and 27.5 µg twice) in QVA149 compared to 75 µg indacaterol monotherapy.
- Trial name
- QAB149 (NCT01959412)
- Testing
- Indacaterol 27.5 mcg, Indacaterol 37.5, Indacaterol 55 mcg
- Where
- 12 sites in United States
- Volunteers
- 91 people
- Sponsor
- Novartis Pharmaceuticals
GENITAL HERPES
Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes
Recurrent genital herpes is a commonly occurring sexually transmitted disease caused by herpes simplex virus (HSV). There are effective oral prescription antiviral medicines available to reduce the discomfort of symptoms, such as…
- Trial name
- NCT01281007
- Testing
- Famciclovir, Aciclovir
- Where
- 9 sites in Brazil
- Volunteers
- 150 people
- Sponsor
- EMS
Asthma
Montelukast in Pediatric Patients Aged 6 to 24 Months With Asthma--Safety Study (0476-176)
A study of Montelukast compared to placebo in asthmatic children aged 6-24 months.
- Trial name
- NCT00943683
- Testing
- montelukast sodium
- Volunteers
- 256 people
- Sponsor
- Organon and Co
Prostate Cancer
An Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Prostate Cancer
This was an extension study for the study FE200486 CS12 (NCT00819156). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.
- Trial name
- NCT00215683
- Testing
- Degarelix
- Where
- 34 sites in Belgium, Germany and 5 more
- Volunteers
- 137 people
- Sponsor
- Ferring Pharmaceuticals
Unverricht-Lundborg Disease
Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease (ULD) in Adolescents and Adults
The study will compare the efficacy and safety of Brivaracetam with placebo in patients with Unverricht- Lundborg Disease (ULD).
- Trial name
- NCT00368251
- Testing
- BRV 2.5 mg, BRV 25 mg, BRV 50 mg
- Where
- 18 sites in United States, Canada and 6 more
- Volunteers
- 56 people
- Sponsor
- UCB Pharma
Diabetes Mellitus, Type 2
Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment
The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given over 12 weeks in drug naive or previously treated type 2 diabetic patients…
- Trial name
- NCT01087502
- Testing
- Glimepiride, Linagliptin
- Where
- 52 sites in United States, Australia and 7 more
- Volunteers
- 241 people
- Sponsor
- Boehringer Ingelheim
Moderate to Severe Hypertension
Efficacy and Safety of the Combination of Aliskiren (300 mg) and Amlodipine (10 mg) Compared to Amlodipine (10 mg) Monotherapy in Patients With Moderate to Severe Hypertension
This study will compare the blood pressure (BP) lowering effect of the combination of aliskiren/amlodipine 300/10 mg versus amlodipine 10 mg monotherapy in patients with moderate to severe hypertension by testing the hypothesis…
- Trial name
- NCT00841672
- Testing
- Aliskiren/amlodipine 300/10 mg tablet, Amlodipine 10 mg capsule
- Where
- 6 sites in Germany, Philippines and 4 more
- Volunteers
- 485 people
- Sponsor
- Novartis
Metastatic Castration-resistant Prostate Cancer (mCRPC)
A Study to Evaluate the Potential Increased Risk of Seizures Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With Enzalutamide
The objective of this study was to evaluate the incidence of seizures and monitor the safety of enzalutamide treatment in participants with metastatic castration-resistant prostate cancer (mCRPC) known to have risk factor(s) for…
- Trial name
- UPWARD (NCT01977651)
- Testing
- Enzalutamide
- Where
- 76 sites in United States, Argentina and 18 more
- Volunteers
- 424 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Rheumatoid Arthritis
Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate.
The purpose of the study was to assess the safety, immunogenicity, and clinical efficacy of adalimumab compared with placebo (during double-blind phase) and to to evaluate the long-term safety and maintenance of efficacy…
- Trial name
- NCT00195702
- Testing
- Adalimumab
- Where
- 87 sites in United States, Canada
- Volunteers
- 619 people
- Sponsor
- Abbott
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