Clinical trials: in Romania
Ischemic Stroke; Ischemic Attack, Transient
A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE
The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke.
- Trial name
- LIBREXIA-STROK (NCT05702034)
- Testing
- Milvexian
- Where
- 880 sites in United States, Argentina and 45 more
- Volunteers
- 12,523 people
- Sponsor
- Janssen Research & Development, LLC
Carcinoma, Non-Small Cell Lung
A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer
The purpose of ARTEMIDE-Lung04 is to assess the efficacy and safety of rilvegostomig compared with pembrolizumab monotherapy as 1L treatment in participants with mNSCLC and whose tumors express PD-L1.
- Trial name
- ARTEMIDELung04 (NCT06868277)
- Testing
- Rilvegostomig, Pembrolizumab
- Where
- 304 sites in United States, Argentina and 25 more
- Volunteers
- 830 people
- Sponsor
- AstraZeneca
Metastatic Non Small Cell Lung Cancer
Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations
This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic non-small cell lung cancer…
- Trial name
- TROPION-Lung08 (NCT05215340)
- Testing
- Datopotamab Deruxtecan, Pembrolizumab
- Where
- 234 sites in United States, Argentina and 26 more
- Volunteers
- 740 people
- Sponsor
- Daiichi Sankyo
Relapsed or Refractory Multiple Myeloma
A Study to Evaluate Mezigdomide in Combination With Carfilzomib and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (SUCCESSOR-2)
The purpose of the study is to compare Mezigdomide (CC-92480/BMS-986348) with carfilzomib and dexamethasone (MeziKD) against carfilzomib and dexamethasone (Kd) in the treatment of RRMM: SUCCESSOR-2.
- Trial name
- SUCCESSOR-2 (NCT05552976)
- Testing
- Mezigdomide, Carfilzomib, Dexamethasone
- Where
- 204 sites in United States, Argentina and 25 more
- Volunteers
- 606 people
- Sponsor
- Bristol-Myers Squibb
Neoplasms, Head and Neck
A Platform Study of Novel Immunotherapy Combinations as First-Line Treatment in Participants With PD-L1 Positive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck- GALAXIES H&N-202
The primary purpose of the study is to evaluate the antitumor activity and safety of novel immunotherapy combinations compared with dostarlimab in participants with Programmed death ligand 1 (PD-L1) positive Recurrent/Metastatic…
- Trial name
- NCT06062420
- Testing
- Dostarlimab, Belrestotug, Nelistotug
- Where
- 108 sites in United States, Argentina and 18 more
- Volunteers
- 316 people
- Sponsor
- GlaxoSmithKline
Small Cell Lung Cancer
Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)
Researchers are looking for new ways to treat Limited-Stage Small Cell Lung Cancer (LS-SCLC), a type of lung cancer that has not spread from the lung to other parts of the body.
- Trial name
- NCT04624204
- Testing
- Pembrolizumab 200 mg, Pembrolizumab 400 mg, Olaparib 300 mg BID
- Where
- 187 sites in United States, Australia and 23 more
- Volunteers
- 672 people
- Sponsor
- Merck Sharp & Dohme LLC
Elevated Lp(a), Atherosclerotic Cardiovascular Disease (ASCVD)
Assessing the Impact of Muvalaplin on Major Cardiovascular Events in Adults With Elevated Lipoprotein(a)
The purpose of this study is to evaluate the efficacy of muvalaplin in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke.
- Trial name
- MOVE-Lp(a) (NCT07157774)
- Testing
- Muvalaplin
- Where
- 804 sites in United States, Argentina and 26 more
- Volunteers
- 10,450 people
- Sponsor
- Eli Lilly and Company
Renal Insufficiency, Chronic
A Phase III Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With CKD Stage 3b and 4 (BalanceD-CKD)
The purpose of this study is to evaluate the efficacy, safety and tolerability of balcinrenone in fixed combination with dapagliflozin, compared with dapagliflozin, in patients with CKD Stage 3b and 4 (eGFR ≥ 15 to < 45…
- Trial name
- NCT07624305
- Testing
- Balcinrenone/dapagliflozin, Dapagliflozin
- Where
- 478 sites in United States, Argentina and 25 more
- Volunteers
- 2,800 people
- Sponsor
- AstraZeneca
Chronic Heart Failure
Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects With Heart Failure With Reduced Ejection Fraction
This study will evaluate the efficacy, safety, tolerability and pharmacokinetics of JTT-861 administered once daily for 12 weeks in subjects with heart failure with reduced ejection fraction (HFrEF) who are on a stable…
- Trial name
- POWER-HF (NCT06017609)
- Testing
- JTT-861 Capsules
- Where
- 75 sites in United States, Bulgaria and 4 more
- Volunteers
- 314 people
- Sponsor
- Shionogi Inc.
Chronic Lymphocytic Leukemia
REAl-world Outcomes in CHronic Lymphocytic Leukemia Patients Receiving Acalabrutinib in Romania
Acalabrutinib received European Medicines Agency approval on November 2020 for for CLL adult patients, either as monotherapy or in combination with obinutuzumab, in previously untreated patients or as monotherapy in patients who…
- Trial name
- REACH (NCT06170671)
- Testing
- Non interventional study
- Where
- 19 sites in Romania
- Volunteers
- 250 people
- Sponsor
- AstraZeneca
Breast Cancer, Locally Advanced Breast Cancer
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.
- Conditions
- Breast Cancer, Locally Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer
- Trial name
- OPERA-02 (NCT07085767)
- Testing
- Palazestrant, Ribociclib, Letrozole
- Where
- 200 sites in United States, Australia and 21 more
- Volunteers
- 1,000 people
- Sponsor
- Olema Pharmaceuticals, Inc.
Carcinoma, Non-Small-Cell Lung
A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)
The purpose of this study is to evaluate the efficacy and safety of repotrectinib and crizotinib in participants with locally advanced or metastatic TKI-naïve ROS1-positive non-small cell lung cancer (NSCLC).
- Trial name
- NCT06140836
- Testing
- Repotrectinib, Crizotinib
- Where
- 122 sites in United States, Argentina and 19 more
- Volunteers
- 190 people
- Sponsor
- Bristol-Myers Squibb
Huntington Disease
A Study to Investigate the Efficacy, Safety and Tolerability of Votoplam in Participants With Huntington's Disease
The purpose is to assess safety and tolerability of votoplam and to determine whether votoplam slows disease progression in patients with early symptomatic Huntington's disease (HD) compared to the control arm.
- Trial name
- INVEST-HD (NCT07326709)
- Testing
- Votoplam (blinded)
- Where
- 117 sites in United States, Argentina and 25 more
- Volunteers
- 770 people
- Sponsor
- Novartis Pharmaceuticals
Relapsing-remitting Multiple Sclerosis (RRMS)
Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)
The Main objectives of the study are to demonstrate pharmacokinetic (PK) similarity between ABP 692 and ocrelizumab (US), as well as between ABP 692 and ocrelizumab (EU).
- Trial name
- NCT06700343
- Testing
- Ocrelizumab (US), Ocrelizumab (EU), ABP 692
- Where
- 109 sites in United States, Belgium and 20 more
- Volunteers
- 152 people
- Sponsor
- Amgen
Asthma
Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma
This is a parallel-group, Phase 2, randomized, double-blind, placebo-controlled, 2-arm study for the treatment of asthma. The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with…
- Trial name
- AIRLYMPUS (NCT06676319)
- Testing
- Lunsekimig, Short-Acting Beta Agonists (SABA), Fluticasone/Salmeterol
- Where
- 221 sites in United States, Argentina and 20 more
- Volunteers
- 556 people
- Sponsor
- Sanofi
Physical Activity, Exercise Adherence
AI-Personalized Digital Exercise for University Students
This study evaluated whether an AI-personalized digital exercise programme could improve exercise adherence, physical activity, wellbeing, and physical performance among university students compared with a standardized digital…
- Conditions
- Physical Activity, Exercise Adherence, Wellbeing
- Trial name
- AIPDEUS (NCT07825948)
- Testing
- AI-Personalized Digital Exercise Programme, Standardized Digital Exercise Programme
- Where
- Romania
- Volunteers
- 299 people, healthy volunteers welcome
- Sponsor
- Transilvania University of Brasov
Clear Cell Renal Cell Carcinoma
A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread
The purpose of this study is to evaluate the drug levels, efficacy, safety, and tolerability of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is…
- Trial name
- CheckMate-67T (NCT04810078)
- Testing
- Nivolumab and rHuPH20, Nivolumab
- Where
- 89 sites in United States, Argentina and 15 more
- Volunteers
- 681 people
- Sponsor
- Bristol-Myers Squibb
Solid Tumors
Avelumab Program Rollover Study
The main purpose of this study is to monitor the safety and tolerability of avelumab in participants with solid tumors who continue treatment with avelumab under the same treatment regimen as in the parent avelumab study.
- Trial name
- NCT03815643
- Testing
- Avelumab
- Where
- 104 sites in United States, Argentina and 20 more
- Volunteers
- 205 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
COPD, COPD Exacerbation
A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD
The purpose of this study is to compare CHF 5993 with CHF 1535 in improving lung function, reducing moderate and severe COPD exacerbations, and other clinical efficacy and safety outcomes in the target subject population.
- Trial name
- TRITON (NCT04320342)
- Testing
- Beclomethasone Dipropionate, Glycopyrronium Bromide, Formoterol Fumarate
- Where
- 436 sites in United States, Argentina and 8 more
- Volunteers
- 3,406 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
End Stage Kidney Disease
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)
This is a two-part, phase 2b and phase 3 combined prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study. Part 1: Phase 2b is a dose-finding study for CSL300 vs placebo.
- Trial name
- POSIBIL6ESKD (NCT05485961)
- Testing
- CSL300
- Where
- 566 sites in United States, Argentina and 33 more
- Volunteers
- 3,110 people
- Sponsor
- CSL Behring
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