Clinical trials: in Colombia
Fascioliasis
Study of Safety, Tolerability and Clinical Outcomes of Egaten in Fascioliasis Patients (6 Years of Age or Older).
The study evaluated safety and tolerability along with clinical outcomes of Egaten administered as per the FDA approved dosing regimen of 2 doses of 10 mg/kg (given approximately 12 hours apart) in Fascioliasis participants (≥ 6…
- Trial name
- NCT04230148
- Testing
- Egaten (Triclabendazole) 250 mg tablets
- Where
- 10 sites in Colombia, Egypt and 3 more
- Volunteers
- 301 people
- Sponsor
- Novartis Pharmaceuticals
Hypertension, Pulmonary
A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension
The purpose of this study is to evaluate whether the addition of selexipag to standard of care treatment delays disease progression in children with Pulmonary Arterial Hypertension (PAH) in comparison to placebo.
- Trial name
- SALTO (NCT04175600)
- Testing
- Selexipag, Standard of Care (SOC): Endothelin receptor antagonist, SOC: Phosphodiesterase type 5 (PDE-5) inhibitor
- Where
- 116 sites in United States, Australia and 30 more
- Volunteers
- 138 people
- Sponsor
- Actelion
Migraine
Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine
This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with chronic migraine.
- Trial name
- OASIS(CM) (NCT03832998)
- Testing
- Erenumab Dose 1, Erenumab Dose 2, Erenumab Dose 3
- Where
- 101 sites in United States, Belgium and 11 more
- Volunteers
- 284 people
- Sponsor
- Amgen
Sickle Cell Disease (SCD)
Study of Two Doses of Crizanlizumab Versus Placebo in Adolescent and Adult Sickle Cell Disease Patients
The purpose of this study is to compare the efficacy and safety of 2 doses of crizanlizumab (5.0 mg/kg and 7.5 mg/kg) versus placebo in adolescent and adult sickle cell disease (SCD) patients with history of vaso-occlusive crisis…
- Trial name
- STAND (NCT03814746)
- Testing
- Crizanlizumab (SEG101)
- Where
- 58 sites in United States, Belgium and 19 more
- Volunteers
- 253 people
- Sponsor
- Novartis Pharmaceuticals
Hypertension, Pulmonary
Riociguat in Children With Pulmonary Arterial Hypertension (PAH)
This study was designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of riociguat at age-, sex- and body-weight-adjusted doses of 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID in children from ≥6 to…
- Trial name
- PATENT-CHILD (NCT02562235)
- Testing
- Riociguat (Adempas, BAY63-2521)
- Where
- 16 sites in Colombia, Germany and 7 more
- Volunteers
- 24 people
- Sponsor
- Bayer
Melanoma
A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010)
The primary purpose of this study is to compare pembrolizumab/vibostolimab to pembrolizumab with respect to recurrence-free survival (RFS).
- Trial name
- NCT05665595
- Testing
- Pembrolizumab/Vibostolimab, Pembrolizumab
- Where
- 205 sites in United States, Argentina and 24 more
- Volunteers
- 1,594 people
- Sponsor
- Merck Sharp & Dohme LLC
Asthma
Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (LOGOS)
This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care.
- Trial name
- LOGOS (NCT04609904)
- Testing
- BGF MDI 320/28.8/9.6 μg, BGF MDI 320/14.4/9.6 μg, BFF MDI 320/9.6 μg
- Where
- 317 sites in United States, Brazil and 14 more
- Volunteers
- 2,187 people
- Sponsor
- AstraZeneca
Asthma
A Study of Lebrikizumab in Adolescent Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication
This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy, safety, and tolerability of lebrikizumab in adolescent participants with asthma whose disease remains uncontrolled…
- Trial name
- NCT01875003
- Testing
- Lebrikizumab, Standard of Care
- Where
- 81 sites in United States, Argentina and 19 more
- Volunteers
- 346 people
- Sponsor
- Hoffmann-La Roche
Progressive Familial Intrahepatic Cholestasis (PFIC)
An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)
The primary objective of this open label extension study is to evaluate the long-term safety and tolerability of maralixibat.
- Trial name
- NCT04185363
- Testing
- Maralixibat
- Where
- 28 sites in United States, Argentina and 14 more
- Volunteers
- 84 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Atopic Dermatitis
Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)
The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
- Trial name
- Measure Up 1 (NCT03569293)
- Testing
- Upadacitinib
- Where
- 180 sites in United States, Argentina and 23 more
- Volunteers
- 912 people
- Sponsor
- AbbVie
Schizophrenia
A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo.
- Trial name
- NCT04072354
- Testing
- SEP-363856 50mg, SEP-363856 75mg
- Where
- 53 sites in United States, Bulgaria and 4 more
- Volunteers
- 463 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
RSV Infection
Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)
This study aims to evaluate the safety and tolerability of clesrovimab compared to palivizumab as assessed by the proportion of participants experiencing adverse events (AEs).
- Trial name
- SMART (NCT04938830)
- Testing
- Clesrovimab, Palivizumab
- Where
- 146 sites in United States, Australia and 25 more
- Volunteers
- 1,003 people
- Sponsor
- Merck Sharp & Dohme LLC
Alopecia Areata
Long-Term PF-06651600 for the Treatment of Alopecia Areata
This is a global Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have alopecia areata.
- Trial name
- ALLEGRO-LT (NCT04006457)
- Testing
- PF-06651600, Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine, Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine
- Where
- 144 sites in United States, Argentina and 15 more
- Volunteers
- 1,057 people
- Sponsor
- Pfizer
Respiratory Syncytial Virus Infections
A Follow-up Study to Describe the Safety of Study Participants Who Received RSVPreF3 Maternal Vaccination (Any Dose) or Controls From Previous RSV MAT Studies During Any Pregnancy Conceived Post Vaccination/Control
The purpose of this follow-up study was to describe the safety in subsequent pregnancies in participants who were previously administered the RSVPreF3 maternal vaccine or control during any prior RSV MAT study.
- Trial name
- NCT05705440
- Testing
- RSVPreF3 vaccine, Control
- Where
- 138 sites in United States, Argentina and 21 more
- Volunteers
- 3,855 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pulmonary Arterial Hypertension
A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH)
This is a prospective, multicenter, open-label, randomized, controlled, parallel Phase 3 study with an open-label single-arm extension period to evaluate pharmacokinetics (PK), safety and efficacy of macitentan in children with…
- Trial name
- TOMORROW (NCT02932410)
- Testing
- Macitentan, Standard-of-care
- Where
- 85 sites in United States, Australia and 21 more
- Volunteers
- 165 people
- Sponsor
- Actelion
Pneumococcal Infection
A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013)
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V116 compared to PPSV23 in children and teenagers 2 through 17 years of age, who had completed routine pneumococcal vaccine as…
- Trial name
- STRIDE-13 (NCT06177912)
- Testing
- V116, PPSV23
- Where
- 92 sites in United States, Canada and 11 more
- Volunteers
- 882 people
- Sponsor
- Merck Sharp & Dohme LLC
Respiratory Syncytial Virus Infection
Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)
The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of clesrovimab in healthy pre-term and full-term infants.
- Trial name
- CLEVER (NCT04767373)
- Testing
- Clesrovimab
- Where
- 217 sites in United States, Argentina and 22 more
- Volunteers
- 3,632 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Suspected or Documented Gram-negative Bacterial Infection
Safety, Tolerability, Efficacy and Pharmacokinetics of Imipenem/Cilastatin/Relebactam (MK-7655A) in Pediatric Participants With Gram-negative Bacterial Infection (MK-7655A-021)
The primary purpose of this study is to evaluate the safety and tolerability of imipenem/cilastatin/relebactam (IMI/REL) in participants from birth to less than 18 years of age with confirmed or suspected gram-negative bacterial…
- Trial name
- NCT03969901
- Testing
- IMI/REL, Active Control, Oral Switch
- Where
- 67 sites in United States, Bulgaria and 16 more
- Volunteers
- 115 people
- Sponsor
- Merck Sharp & Dohme LLC
Mild Asthma
Study of QMF149 (150/80 µg) Compared With MF Twisthaler® (200 µg) in Patients With Asthma
The purpose of the trial was to evaluate efficacy and safety of QMF149 150/80 microgram o.d. delivered via Concept1 compared to MF 200 microgram o.d., delivered via Twisthaler® in terms of lung function and symptom control in…
- Trial name
- NCT02892344
- Testing
- QMF149 150/80 μg, MF 200 μg
- Where
- 123 sites in Bulgaria, Chile and 20 more
- Volunteers
- 802 people
- Sponsor
- Novartis Pharmaceuticals
Asthma
Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma
A randomized, multicenter, double-blind, placebo- controlled parallel-group study to determine the efficacy and safety of QAW039, compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult and adolescent…
- Trial name
- NCT03226392
- Testing
- QAW039
- Where
- 142 sites in United States, Brazil and 16 more
- Volunteers
- 704 people
- Sponsor
- Novartis Pharmaceuticals