Clinical trials: in Romania
Psychosis Associated With Alzheimer's Disease
Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)
This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027 or CN012-0056.
- Trial name
- NCT05980949
- Testing
- KarXT
- Where
- 432 sites in United States, Argentina and 29 more
- Volunteers
- 1,000 people
- Sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Atopic Dermatitis
A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic…
- Trial name
- Switch-Up (NCT06389136)
- Testing
- Upadacitinib 15mg Dose, Dupilumab 300mg Dose, Upadacitinib 30mg Dose
- Where
- 129 sites in United States, Canada and 7 more
- Volunteers
- 184 people
- Sponsor
- AbbVie
Cushing's Disease
A Trial of Lu AG13909 in Adult Participants With Cushing's Disease
This trial will evaluate the effects of Lu AG13909 in adult participants with Cushing's disease (CD). CD is a rare and serious disorder where the body makes too much of a hormone called cortisol.
- Trial name
- BalanCeD (NCT06471829)
- Testing
- Lu AG13909
- Where
- 27 sites in United States, France and 7 more
- Volunteers
- 16 people
- Sponsor
- H. Lundbeck A/S
Chronic Obstructive Pulmonary Disease
A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
This study will evaluate the efficacy, safety, and pharmacokinetics of astegolimab in combination with standard of care chronic obstructive pulmonary disease (COPD) maintenance therapy in patients with COPD who are former or…
- Trial name
- NCT05037929
- Testing
- Astegolimab
- Where
- 193 sites in United States, Argentina and 22 more
- Volunteers
- 1,334 people
- Sponsor
- Genentech, Inc.
Immune Thrombocytopenia (ITP), ITP - Immune Thrombocytopenia
A Study of Efgartigimod IV in Participants From 12 Years to Less Than 18 Years of Age With Chronic Immune Thrombocytopenia (ITP)
The main purpose of this study is to confirm the correct dose of efgartigimod IV for treating patients aged 12 to younger than 18 years with chronic immune thrombocytopenia (ITP).
- Conditions
- Immune Thrombocytopenia (ITP), ITP - Immune Thrombocytopenia, ITP, Immune Thrombocytopenic Purpura
- Trial name
- Advance Jr (NCT07194850)
- Testing
- Efgartigimod IV
- Where
- 26 sites in France, Germany and 8 more
- Volunteers
- 24 people
- Sponsor
- argenx
Hidradenitis Suppurativa
A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa
The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) Dose A and Dose B compared to placebo in participants with moderate to severe hidradenitis suppurativa (HS).
- Trial name
- RECHARGE-2 (NCT06840392)
- Testing
- Remibrutinib Dose A, Remibrutinib Dose B
- Where
- 129 sites in United States, Argentina and 17 more
- Volunteers
- 565 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Lupus Erythematosus
The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)
The purpose of the study is to evaluate the long term safety and efficacy of orally administered M5049 in participants with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE) and/or systemic lupus…
- Trial name
- NCT05540327
- Testing
- M5049 low dose, M5049 medium dose, M5049 high dose
- Where
- 122 sites in United States, Argentina and 20 more
- Volunteers
- 381 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Early Breast Cancer
A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)
This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with physician's choice of endocrine therapy in participants with medium- and high-risk…
- Trial name
- NCT04961996
- Testing
- Giredestrant, Physician's Choice of Endocrine Therapy, LHRH Agonist
- Where
- 621 sites in United States, Argentina and 52 more
- Volunteers
- 4,170 people
- Sponsor
- Hoffmann-La Roche
Sjogrens Syndrome
A Randomized, Double-blind 2-arm, Followed by an Open-label 1-arm, NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.
The purpose of this study is to measure the long-term safety and tolerability of ianalumab in participants with Sjögren's syndrome who have previously completed treatment from one of two NEPTUNUS 1 year core studies (CVAY736A2301…
- Trial name
- NEPTUNUS-Ext (NCT05985915)
- Testing
- Ianalumab (VAY736)
- Where
- 198 sites in United States, Argentina and 33 more
- Volunteers
- 612 people
- Sponsor
- Novartis Pharmaceuticals
Alzheimer Disease
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.
- Trial name
- NCT07011732
- Testing
- Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule
- Where
- 162 sites in United States, Argentina and 13 more
- Volunteers
- 426 people
- Sponsor
- Bristol-Myers Squibb
Carcinoid Syndrome, Carcinoid
Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen
A Phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of paltusotine treatment vs placebo as well as the long-term safety of paltusotine in adults with carcinoid syndrome due to…
- Conditions
- Carcinoid Syndrome, Carcinoid, Carcinoid Tumor, Carcinoid Tumor of Ileum
- Trial name
- CAREFNDR (NCT07087054)
- Testing
- Paltusotine
- Where
- 72 sites in United States, Argentina and 12 more
- Volunteers
- 141 people
- Sponsor
- Crinetics Pharmaceuticals Inc.
Lupus Nephritis
Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis
This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN
- Trial name
- SIRIUS-LN (NCT05126277)
- Testing
- ianalumab s.c. q4w, ianalumab s.c. q12w
- Where
- 145 sites in United States, Argentina and 25 more
- Volunteers
- 452 people
- Sponsor
- Novartis Pharmaceuticals
Major Depressive Disorder
A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3)
X-NOVA3 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of azetukalner as a monotherapy in adult participants diagnosed with Major…
- Trial name
- X-NOVA3 (NCT07076407)
- Testing
- Azetukalner
- Where
- 50 sites in United States, Finland and 5 more
- Volunteers
- 450 people
- Sponsor
- Xenon Pharmaceuticals Inc.
Asthma
A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate/Mometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma
The purpose of this study is to evaluate the superiority in terms of efficacy and evaluate the safety of QMF149 (indacaterol (acetate) / mometasone (furoate)) compared to budesonide in children from 6 to less than 12 years of age…
- Trial name
- NCT05562466
- Testing
- QMF149, Budesonide
- Where
- 65 sites in Argentina, Austria and 15 more
- Volunteers
- 200 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Inducible Urticaria
A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
This is a Phase 3, parallel group, placebo-controlled, double-blind, confirmatory study in patients with CINDU, with an optional Open-label Extension (OLE).
- Trial name
- NCT05976243
- Testing
- Remibrutinib
- Where
- 130 sites in United States, Argentina and 26 more
- Volunteers
- 362 people
- Sponsor
- Novartis Pharmaceuticals
Relapsed/Refractory Follicular Lymphoma, Marginal Zone Lymphoma
A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
The purpose of the study is to compare the efficacy of zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab (R^2) in participants with relapsed/refractory (R/R) follicular lymphoma (FL), as measured by…
- Trial name
- MAHOGANY (NCT05100862)
- Testing
- Zanubrutinib, Rituximab, Lenalidomide
- Where
- 264 sites in United States, Argentina and 26 more
- Volunteers
- 799 people
- Sponsor
- BeOne Medicines
High Risk Cardiovascular Disease, Hypertension
Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
The purpose of this study is to evaluate whether zilebesiran versus placebo reduces the risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events.
- Conditions
- High Risk Cardiovascular Disease, Hypertension, High Cardiovascular Risk
- Trial name
- ZENITH (NCT07181109)
- Testing
- Zilebesiran
- Where
- 1,190 sites in United States, Argentina and 33 more
- Volunteers
- 11,000 people
- Sponsor
- Alnylam Pharmaceuticals
Asthma
A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Versus Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.
The purpose of this study is to evaluate the efficacy and safety of indacaterol acetate / glycopyrronium bromide / mometasone furoate (QVM149) compared to salmeterol xinafoate / fluticasone propionate in children from 12 to less…
- Trial name
- NCT05776927
- Testing
- QVM149, Salmeterol Xinafoate / Fluticasone Propionate
- Where
- 22 sites in Argentina, France and 7 more
- Volunteers
- 188 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Obstructive Pulmonary Disease
Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)
Primary Objective: Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD Secondary Objectives: Evaluate the…
- Trial name
- AERIFY-1 (NCT04701983)
- Testing
- Itepekimab SAR440340
- Where
- 232 sites in United States, Argentina and 19 more
- Volunteers
- 1,127 people
- Sponsor
- Sanofi
ASA Class III/IV Patients, COPD III/IV
Remimazolam Versus Propofol for Procedural Sedation in Gastrointestinal Endoscopy: A Single-Centre Prospective Observational Comparative Study in a High-Risk Population
Remimazolam is a new, ultra-short-acting benzodiazepine approved in Romania for procedural sedation. It shows significant clinical benefits compared to other sedatives like Propofol or Midazolam, especially in elderly or…
- Conditions
- ASA Class III/IV Patients, COPD III/IV, Age 65 and Older, Multiple Organ Failure
- Trial name
- NCT07362173
- Testing
- Administering remimazolam, Administering propofol
- Where
- Romania
- Volunteers
- 203 people
- Sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
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