Clinical trials: in Bulgaria
Arthritis, Psoriatic
Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent
The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) and/or intolerance to a prior anti-tumor necrosis factor (TNF) by…
- Trial name
- SOLSTICE (NCT04936308)
- Testing
- Guselkumab
- Where
- 169 sites in United States, Argentina and 12 more
- Volunteers
- 453 people
- Sponsor
- Janssen Research & Development, LLC
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
Major Depressive Disorder (MDD)
A Study to Assess the Skin Irritation and Sensitization of Selegiline TDS in Healthy Subjects
The two products used in this study are transdermal patches that contain selegiline. The test drug is the Selegiline Transdermal Delivery System (TDS). The comparator drug is the EMSAM® TDS.
- Trial name
- NCT07452692
- Testing
- Selegiline Transdermal Delivery System
- Where
- 3 sites in Bulgaria
- Volunteers
- 232 people, healthy volunteers welcome
- Sponsor
- Corium Innovations, Inc.
Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Rationale: LTI-03 is an experimental medication breathed into the lungs using an inhaler. It is being studied for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
- Trial name
- NCT06968845
- Testing
- LTI-03, Dry Powder Inhaler
- Where
- 48 sites in United States, Australia and 5 more
- Volunteers
- 120 people
- Sponsor
- Rein Therapeutics
Hypertension, Pulmonary
A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option
The purpose of the study is to enable participants with pulmonary hypertension (PH) currently treated with study intervention(s) in a clinical study (parent studies [NCT03422328, NCT03904693,NCT04565990, NCT02932410, NCT03492177…
- Trial name
- PLATYPUS (NCT05179876)
- Testing
- Macitentan, Selexipag, Macitentan/Tadalafil FDC
- Where
- 45 sites in Belarus, Belgium and 11 more
- Volunteers
- 280 people
- Sponsor
- Actelion
Generalized Anxiety Disorder
Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder
This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of ITI-1284 as monotherapy treatment in patients meeting Diagnostic and Statistical Manual of Mental…
- Trial name
- NCT06701903
- Testing
- ITI-1284 10 mg, ITI-1284 20 mg
- Where
- 51 sites in United States, Bulgaria and 3 more
- Volunteers
- 570 people
- Sponsor
- Intra-Cellular Therapies, Inc.
SARS-CoV-2
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
The primary purpose of this study is to evaluate the efficacy and safety of secutrelvir in symptomatic nonhospitalized adult and adolescent participants with COVID-19 who are at high risk for progression to severe disease.
- Trial name
- NCT07743580
- Testing
- Secutrelvir
- Where
- 51 sites in United States, Bulgaria and 1 more
- Volunteers
- 2,000 people
- Sponsor
- Shionogi
Lupus Erythematosus, Systemic
A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
The purpose of this study is to evaluate how well nipocalimab works as compared to placebo in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks…
- Trial name
- GARDENIA-SLE (NCT07438496)
- Testing
- Nipocalimab, Standard of care treatment
- Where
- 272 sites in United States, Argentina and 31 more
- Volunteers
- 600 people
- Sponsor
- Janssen Research & Development, LLC
Pulmonary Arterial Hypertension
Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension
The purpose of this study is to demonstrate superiority of macitentan 75 milligrams (mg) in prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or mortality (M/M) event in participants with…
- Trial name
- UNISUS (NCT04273945)
- Testing
- Macitentan 10 mg, Macitentan 37.5 mg, Macitentan 75 mg
- Where
- 274 sites in United States, Argentina and 40 more
- Volunteers
- 935 people
- Sponsor
- Actelion
Uncontrolled Hypertension, Resistant Hypertension
A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension
This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered once daily (QD) orally…
- Trial name
- BaxHTN (NCT06034743)
- Testing
- Baxdrostat
- Where
- 263 sites in United States, Argentina and 27 more
- Volunteers
- 796 people
- Sponsor
- AstraZeneca
Pain Management, Psychiatric Comorbidities
Accelerated Dual-Protocol rTMS for Refractory Trigeminal Neuralgia
Brief Summary The goal of this clinical trial is to learn if an accelerated, dual-protocol high-frequency repetitive transcranial magnetic stimulation (rTMS) intervention can treat and achieve long-term pain relief (analgesia) in…
- Trial name
- rTMS-TN-M1 (NCT07908420)
- Where
- Bulgaria
- Volunteers
- 192 people
- Sponsor
- Galileo Medical Center
Psychotic Disorders, Alzheimer Disease
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease
This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, flexible-dose study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo in the treatment of psychosis in…
- Trial name
- NCT06540833
- Testing
- ITI-1284
- Where
- 71 sites in United States, Bulgaria and 8 more
- Volunteers
- 370 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Major Depressive Disorder
Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
This is a multicenter, randomized, double-blind, placebo-controlled parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders…
- Trial name
- NCT05850689
- Testing
- Lumateperone
- Where
- 69 sites in United States, Bulgaria and 5 more
- Volunteers
- 470 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Generalized Anxiety Disorder
Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder
This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo as adjunctive therapy to GAD treatment in patients meeting Diagnostic…
- Trial name
- NCT06480383
- Testing
- ITI-1284 10 mg, ITI-1284 20 mg
- Where
- 59 sites in United States, Bulgaria and 4 more
- Volunteers
- 705 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Chronic Spontaneous Urticaria
Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
The purpose of this extension study is to collect long-term efficacy and safety data on barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who completed the treatment and follow-up periods of the Phase 3…
- Trial name
- NCT07256392
- Testing
- barzolvolimab, Standard of Care
- Where
- 201 sites in United States, Argentina and 28 more
- Volunteers
- 1,370 people
- Sponsor
- Celldex Therapeutics
Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus
The goal of this clinical trial is to learn if VENT-03 works to treat patients with cutaneous lupus erythematosus (CLE) who may or may not have systemic lupus erythematosus (SLE).
- Conditions
- Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus, SLE, SLE (Systemic Lupus)
- Trial name
- AERIS (NCT07260877)
- Testing
- VENT-03
- Where
- 34 sites in United States, Bulgaria and 6 more
- Volunteers
- 24 people
- Sponsor
- Ventus Therapeutics U.S., Inc.
NASH - Nonalcoholic Steatohepatitis
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3
- Trial name
- NATiV3 (NCT04849728)
- Testing
- IVA337
- Where
- 459 sites in United States, Argentina and 22 more
- Volunteers
- 1,000 people
- Sponsor
- Inventiva Pharma
Focal Epilepsy, Tonic-Clonic Seizures
An Open-label Study of XEN1101 in Epilepsy
This study will evaluate the long term safety, tolerability, pharmacokinetics (PK), and efficacy of XEN1101 in subjects with Focal Onset Seizures (FOS) or Primary Generalized Tonic-Clonic Seizures (PGTCS) for the treatment of…
- Trial name
- X-TOLE4 (NCT05718817)
- Testing
- XEN1101
- Where
- 153 sites in United States, Argentina and 23 more
- Volunteers
- 880 people
- Sponsor
- Xenon Pharmaceuticals Inc.
Intracranial Arterial Aneurysm
The NUVASCULAR HARBOR Occlusion Device EU Study
The purpose of this study is to evaluate the safety and effectiveness of the HARBOR Occlusion Device for treating brain aneurysms.
- Trial name
- NCT07900464
- Testing
- HARBOR Occlusion Device
- Where
- 2 sites in Austria, Bulgaria
- Volunteers
- 30 people
- Sponsor
- Nuvascular Inc
Clostridium Difficile, Clostridium Difficile Infections
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo.
- Conditions
- Clostridium Difficile, Clostridium Difficile Infections, Clostridium Difficile Infection Recurrence, Clostridioides Difficile Infection
- Trial name
- RESTORATiVE303 (NCT06237452)
- Testing
- VE303
- Where
- 215 sites in United States, Australia and 22 more
- Volunteers
- 852 people
- Sponsor
- Vedanta Biosciences, Inc.
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