Clinical trials: in North Macedonia
Multiple Sclerosis
Oral Cladribine in Early Multiple Sclerosis (MS)
A randomized, double-blind, clinical trial to assess the safety and efficacy of two doses of oral cladribine versus placebo in participants who had a first clinical demyelinating event (clinically isolated syndrome).
- Trial name
- ORACLE MS (NCT00725985)
- Testing
- Cladribine, Rebif® new formulation (RNF)
- Where
- 158 sites in United States, Argentina and 32 more
- Volunteers
- 617 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Severe Haemophilia A
Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A
The rationale of this study is to further fine-tune and individualize prophylactic treatment of patients with severe Haemophilia A with the goal of keeping the trough FVIII level above 1% between doses.
- Trial name
- NCT02256917
- Testing
- Human cl rhFVIII
- Where
- 30 sites in United States, Canada and 7 more
- Volunteers
- 58 people
- Sponsor
- Octapharma
Relapsing-Remitting Multiple Sclerosis
BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and…
- Trial name
- ENDORSE (NCT00835770)
- Testing
- dimethyl fumarate
- Where
- 246 sites in United States, Australia and 32 more
- Volunteers
- 1,736 people
- Sponsor
- Biogen
Gastric Cancer
A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastroesophageal Junction or Gastric Cancer
This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab, fluoropyrimidine and cisplatin as first-line…
- Trial name
- JACOB (NCT01774786)
- Testing
- 5-Fluorouracil, Capecitabine, Cisplatin
- Where
- 172 sites in United States, Australia and 30 more
- Volunteers
- 780 people
- Sponsor
- Hoffmann-La Roche
Cystic Fibrosis
Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) - Extension Phase
A major factor in the respiratory health of cystic fibrosis (CF) patients is acquisition of chronic Pseudomonas (P.) aeruginosa infections. The infection rate with P.
- Trial name
- NCT03905642
- Testing
- Arikayce™
- Where
- 11 sites in Belgium, Hungary and 5 more
- Volunteers
- 49 people
- Sponsor
- Insmed Incorporated
Cystic Fibrosis
Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™)
A major factor in the respiratory health of cystic fibrosis (CF) subjects is acquisition of chronic Pseudomonas aeruginosa infections. The infection rate with P.
- Trial name
- NCT00777296
- Testing
- ARIKACE™
- Where
- 11 sites in Belgium, Hungary and 5 more
- Volunteers
- 66 people
- Sponsor
- Insmed Incorporated
Metastatic Breast Cancer
A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer
This study was a Phase III, randomized, double-blind, placebo-controlled, multicenter international clinical trial conducted to investigate the use of pertuzumab in combination with trastuzumab and docetaxel as first-line…
- Trial name
- CLEOPATRA (NCT00567190)
- Testing
- Pertuzumab, Trastuzumab, Docetaxel
- Where
- 322 sites in United States, Argentina and 24 more
- Volunteers
- 808 people
- Sponsor
- Genentech, Inc.
Heart Failure, Respiratory Insufficiency
A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients
The purpose of this study is to evaluate the efficacy and safety of rivaroxaban compared with placebo in the prevention of symptomatic venous thromboembolism (VTE) events and VTE-related death post-hospital discharge in…
- Conditions
- Heart Failure, Respiratory Insufficiency, Stroke Acute, Infectious Diseases
- Trial name
- MARINER (NCT02111564)
- Testing
- Rivaroxaban, 10 mg, Rivaroxaban, 7.5 mg
- Where
- 593 sites in United States, Argentina and 35 more
- Volunteers
- 12,024 people
- Sponsor
- Janssen Research & Development, LLC
Chronic Lymphocytic Leukemia
A Safety and Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participants With Chronic Lymphocytic Leukemia
This multicenter, open-label, single-arm study will evaluate the safety and efficacy of obinutuzumab alone or in combination with chemotherapy in participants with previously untreated or relapsed/refractory chronic lymphocytic…
- Trial name
- NCT01905943
- Testing
- Bendamustine, Chlorambucil, Cyclophosphamide
- Where
- 174 sites in Argentina, Belgium and 29 more
- Volunteers
- 979 people
- Sponsor
- Hoffmann-La Roche
Rheumatoid Arthritis
A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis
The purpose of this study is to assess the efficacy and safety of dose regimens of ALX-0061 administered subcutaneously (s.c.) in combination with methotrexate (MTX) to subjects with active rheumatoid arthritis (RA) despite MTX…
- Trial name
- NCT02309359
- Testing
- ALX-0061, Methotrexate
- Where
- 94 sites in United States, Belgium and 12 more
- Volunteers
- 345 people
- Sponsor
- Ablynx, a Sanofi company
Rheumatoid Arthritis
A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis
The primary objective of this study is: To assess the efficacy and safety of dose regimens of ALX-0061 monotherapy administered subcutaneously (s.c.) to subjects with active rheumatoid arthritis (RA).
- Trial name
- NCT02287922
- Testing
- ALX-0061, Tocilizumab
- Where
- 83 sites in United States, Belgium and 12 more
- Volunteers
- 251 people
- Sponsor
- Ablynx, a Sanofi company
Rheumatoid Arthritis
An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of ALX-0061 in Subjects With Rheumatoid Arthritis
This was a multicenter, open-label extension (OLE) Phase II study designed to evaluate the long-term efficacy and safety of ALX-0061 (i.e., vobarilizumab) administered subcutaneously (s.c.) in subjects with active rheumatoid…
- Trial name
- NCT02518620
- Testing
- ALX-0061
- Where
- 57 sites in Belgium, Bulgaria and 10 more
- Volunteers
- 406 people
- Sponsor
- Ablynx, a Sanofi company
Diabetes, Diabetes Mellitus, Type 2
Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes
This trial is conducted in Africa, North and South America, Asia and Europe. The purpose of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on…
- Trial name
- SUSTAIN™ 4 (NCT02128932)
- Testing
- semaglutide, insulin glargine
- Where
- 231 sites in United States, Argentina and 13 more
- Volunteers
- 1,089 people
- Sponsor
- Novo Nordisk A/S
Diabetes, Diabetes Mellitus, Type 1
A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus
This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of insulin degludec in children and adolescents with type 1 diabetes mellitus.
- Trial name
- BEGIN™ (NCT01513473)
- Testing
- insulin degludec, insulin detemir, insulin aspart
- Where
- 81 sites in United States, Bulgaria and 10 more
- Volunteers
- 350 people
- Sponsor
- Novo Nordisk A/S
Diabetes, Diabetes Mellitus, Type 1
A Trial Investigating the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily Plus Insulin Aspart for the Remaining Meals Versus Insulin Detemir Once or Twice Daily Plus Meal Time Insulin Aspart in Children and Adolescents With Type 1 Diabetes Mellitus
This trial is conducted in Asia, Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of insulin degludec/insulin aspart once daily plus insulin aspart for the remaining meals in…
- Trial name
- NCT01835431
- Testing
- insulin degludec/insulin aspart, insulin aspart, insulin detemir
- Where
- 73 sites in United States, Belgium and 13 more
- Volunteers
- 362 people
- Sponsor
- Novo Nordisk A/S
Atherosclerotic Cardiovascular Disease
ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab
Primary Objective: To compare the effect of alirocumab with placebo on the occurrence of cardiovascular (CV) events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and…
- Trial name
- NCT01663402
- Testing
- Alirocumab, LMT
- Where
- 1,388 sites in United States, Argentina and 55 more
- Volunteers
- 18,924 people
- Sponsor
- Sanofi
Non-Hodgkin's Lymphoma
A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma
This two-stage, multi-center, randomized, controlled, open-label study will investigate the pharmacokinetics, efficacy and safety of rituximab SC versus rituximab IV in participants with previously untreated follicular…
- Trial name
- NCT01200758
- Testing
- Rituximab SC, Rituximab IV, Cyclophosphamide
- Where
- 152 sites in Australia, Belgium and 28 more
- Volunteers
- 410 people
- Sponsor
- Hoffmann-La Roche
Pulmonary Disease, Chronic Obstructive
Study to Evaluate the Effect of Fluticasone Furoate/Vilanterol on Survival in Subjects With Chronic Obstructive Pulmonary Disease
The purpose of this study is to determine if fluticasone furoate/vilanterol improves survival in patients with chronic obstructive pulmonary disease with a history of or increased risk of heart disease.
- Trial name
- NCT01313676
- Testing
- fluticasone furoate/vilanterol, fluticasone furoate, vilanterol
- Where
- 1,611 sites in United States, Argentina and 42 more
- Volunteers
- 16,568 people
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus, Connective Tissue Disease
A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two different doses of LY2127399 administered in participants with active SLE.
- Conditions
- Systemic Lupus Erythematosus, Connective Tissue Disease, Autoimmune Disease
- Trial name
- NCT01196091
- Testing
- LY2127399, Standard of Care
- Where
- 192 sites in United States, Argentina and 21 more
- Volunteers
- 1,164 people
- Sponsor
- Eli Lilly and Company
Congenital Bleeding Disorder, Haemophilia B
Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773
This trial is conducted in Asia, Europe, Japan, North America and South Africa. The aim is to evaluate the safety and efficacy of nonacog beta pegol (NNC-0156-0000-0009) after long-term exposure in patients with haemophilia B.
- Trial name
- paradigm™ 4 (NCT01395810)
- Testing
- nonacog beta pegol
- Where
- 49 sites in United States, Austria and 16 more
- Volunteers
- 71 people
- Sponsor
- Novo Nordisk A/S