Clinical trials: in Portugal
Metastatic Pancreatic Adenocarcinoma
A Study to Compare Onivyde Manufactured at Two Different Production Sites in Adult Participants With Advanced Cancer in the Pancreas
The aim of this study is to compare Onivyde manufactured at two different production sites in adult participants with advanced cancer in the pancreas.
- Trial name
- SIRACUSA (NCT05383352)
- Testing
- Irinotecan liposome injection, Folinic Acid, 5-Fluorouracil
- Where
- 36 sites in Australia, France and 5 more
- Volunteers
- 177 people
- Sponsor
- Ipsen
Depressive Disorder, Major
A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder
The primary purpose of this study is to evaluate the efficacy of flexibly dosed esketamine nasal spray compared with quetiapine extended-release (XR), both in combination with a continuing selective serotonin reuptake…
- Trial name
- ESCAPE-TRD (NCT04338321)
- Testing
- Esketamine 28 mg, Esketamine 56 mg, Esketamine 84 mg
- Where
- 171 sites in Argentina, Austria and 22 more
- Volunteers
- 676 people
- Sponsor
- Janssen-Cilag International NV
Lupus Erythematosus, Systemic
A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard of care treatments.
- Trial name
- NCT03517722
- Testing
- Ustekinumab (approximately 6 mg/kg), Ustekinumab 90 mg
- Where
- 204 sites in United States, Argentina and 18 more
- Volunteers
- 516 people
- Sponsor
- Janssen Research & Development, LLC
Axial Spondyloarthritis
A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Participants With Active Radiographic Axial Spondyloarthritis
The purpose of this study is to assess the efficacy of ustekinumab, in adult anti-TNF(alpha) refractory participants with active radiographic axial spondyloarthritis (AxSpA), as measured by the reduction in signs and symptoms of…
- Trial name
- NCT02438787
- Testing
- Ustekinumab 45 mg, Ustekinumab 90 mg, Golimumab 50 mg
- Where
- 148 sites in United States, Argentina and 17 more
- Volunteers
- 315 people
- Sponsor
- Janssen Research & Development, LLC
Malignant Melanoma
Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes
The main purpose of this study was to evaluate the impact on pyrexia-related outcomes of an adapted pyrexia adverse event (AE)-management algorithm, as well as safety, efficacy and health-related outcomes.
- Trial name
- COMBI-APlus (NCT03551626)
- Testing
- Dabrafenib, Trametinib
- Where
- 100 sites in Argentina, Australia and 21 more
- Volunteers
- 552 people
- Sponsor
- Novartis Pharmaceuticals
Crohn Disease
Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab
The purpose of this study is to evaluate the efficacy of a treat to target strategy coupled with early endoscopic assessment versus a clinically driven (routine care) approach in achieving endoscopic response.
- Trial name
- STARDUST (NCT03107793)
- Testing
- Ustekinumab
- Where
- 107 sites in Belgium, Czechia and 10 more
- Volunteers
- 500 people
- Sponsor
- Janssen-Cilag Ltd.
Schizophrenia
A Study to Analyze the Impact of Treatment With Paliperidone Palmitate on Clinical Outcomes and Hospital Resource Utilization in Adult Participants With Schizophrenia in Portugal
The purpose of this study is to investigate the mean number of schizophrenia-related hospital admissions, in adult participants with schizophrenia, occurred during 12 months before and 12 months after initiation of Paliperidone…
- Trial name
- PsiProsper (NCT03666715)
- Testing
- Oral Antipsychotics (OAPs), Paliperidone Palmitate 1-Month Formulation (PP1M)
- Where
- Portugal
- Volunteers
- 55 people
- Sponsor
- Janssen-Cilag Farmaceutica Ltda.
Schizophrenia
An Efficacy, Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended Release (ER) in Participants With Schizophrenia
The purpose of this study is to explore tolerability, safety and effectiveness of flexibly dosed paliperidone extended release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability…
- Trial name
- PERFlexS (NCT00460512)
- Testing
- Paliperidone ER
- Where
- 231 sites in Belgium, Bulgaria and 20 more
- Volunteers
- 1,814 people
- Sponsor
- Janssen-Cilag International NV
Depressive Disorder, Treatment-Resistant
Treatment-Resistant Depression Cohort in Europe
The purpose of this study is to assess the participants socio-demographics and disease-related characteristics, long-term naturalistic treatment patterns and the clinical, social and economic outcomes of routine clinical practice…
- Trial name
- NCT03373253
- Where
- 98 sites in Belgium, Germany and 5 more
- Volunteers
- 830 people
- Sponsor
- Janssen-Cilag Ltd.
Advanced Solid Tumors
A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
The primary purpose of this study is to evaluate the tolerability and safety profile of ASP8374 when administered as a single agent and in combination with pembrolizumab in participants with locally advanced (unresectable) or…
- Trial name
- NCT03260322
- Testing
- ASP8374, Pembrolizumab
- Where
- 54 sites in United States, Canada and 7 more
- Volunteers
- 169 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Carcinoma, Non-Small-Cell Lung
An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)
To evaluate the safety and tolerability of afatinib (Giotrif) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s) and have never been treated with an EGFR-TKI
- Trial name
- NCT01853826
- Testing
- Afatinib
- Where
- 118 sites in Australia, Austria and 9 more
- Volunteers
- 481 people
- Sponsor
- Boehringer Ingelheim
Diabetic Retinopathy
Non-proliferative Diabetic Retinopathy Treated With Runcaciguat
This Phase 2 study is conducted to investigate the safety and efficacy of runcaciguat in the treatment of diabetic retinopathy. To assess efficacy, the retinal morphology will be investigated by 7-field color fundus photography…
- Trial name
- NEON-NPDR (NCT04722991)
- Testing
- Runcaciguat (BAY1101042)
- Where
- 55 sites in United States, Bulgaria and 12 more
- Volunteers
- 109 people
- Sponsor
- Bayer
Epilepsy
A Study to Evaluate the Tolerability and Pharmacokinetics of Two Single and Multiple High Dose Regimens of BIA 2-093 In Healthy Volunteers
Single centre, double-blind, randomised, placebo-controlled study of two dosage regimens of BIA 2-093 - 1800 mg (Group 1) and 2400 mg (Group 2) - in two groups of healthy male volunteers
- Trial name
- NCT01879345
- Testing
- BIA 2-093 - 1800 mg (Group 1), BIA 2-093 - 2400 mg (Group 2)
- Where
- Portugal
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Epilepsy
The Effect of BIA 2-093 on the Steady-state Pharmacokinetics of Digoxin
The purpose of this study is to investigate the effects of multiple-dose administration of BIA 2-093 on the steady-state pharmacokinetics of digoxin in healthy subjects.
- Trial name
- NCT02172742
- Testing
- BIA 2-093, Digoxin
- Where
- Portugal
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Epilepsy
Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers
To investigate the steady-state pharmacokinetics of once-daily and twice-daily regimens of BIA 2-093 and twice-daily regimen of Oxcarbazepine (Trileptal®) in healthy subjects and to assess the tolerability of such regimens in…
- Trial name
- NCT01679002
- Testing
- BIA 2-093, Oxcarbazepine
- Where
- Portugal
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Blincyto Use in Routine Clinical Practice
Observational Study of Blinatumomab
An observational study of blinatumomab safety and effectiveness, utilisation, and treatment practices.
- Trial name
- NCT03117621
- Where
- 80 sites in Austria, Czechia and 11 more
- Volunteers
- 279 people
- Sponsor
- Amgen
Melanoma
A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma
The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with…
- Trial name
- NCT03635983
- Testing
- NKTR-214, Nivolumab
- Where
- 167 sites in United States, Argentina and 25 more
- Volunteers
- 783 people
- Sponsor
- Bristol-Myers Squibb
Renal Cell Carcinoma
Trial to Assess Safety and Efficacy of Lenvatinib (18 mg vs. 14 mg) in Combination With Everolimus in Participants With Renal Cell Carcinoma
Study E7080-G000-218 is a Randomized, open-label (formerly Double-blind), Phase 2 Trial conducted to assess whether a starting dose of lenvatinib 14 milligrams (mg) in combination with everolimus 5 mg once daily (QD) will provide…
- Trial name
- NCT03173560
- Testing
- lenvatinib, everolimus
- Where
- 93 sites in United States, Australia and 14 more
- Volunteers
- 343 people
- Sponsor
- Eisai Inc.
Multiple Sclerosis
Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis
International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis
- Trial name
- OPTIMUM (NCT02425644)
- Testing
- ponesimod, teriflunomide
- Where
- 162 sites in United States, Belarus and 26 more
- Volunteers
- 1,133 people
- Sponsor
- Actelion
Pulmonary Arterial Hypertension
Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension.
The primary objective of this study is to evaluate the effect of selexipag on the physical activity of patients with pulmonary arterial hypertension (PAH) in their daily life, by using a wearable wrist device (actigraph).
- Trial name
- TRACE (NCT03078907)
- Testing
- Selexipag
- Where
- 39 sites in United States, Austria and 8 more
- Volunteers
- 108 people
- Sponsor
- Actelion
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