Clinical trials: in North Macedonia
Breast Cancer
A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer
This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel in participants with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and in participants…
- Trial name
- IPATunity130 (NCT03337724)
- Testing
- Ipatasertib, Paclitaxel
- Where
- 176 sites in United States, Argentina and 28 more
- Volunteers
- 579 people
- Sponsor
- Hoffmann-La Roche
Ulcerative Colitis
Phase 2 Dose-finding IMU-838 for Ulcerative Colitis
This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the efficacy and safety of IMU-838 for induction and maintenance therapy with an option for open-label treatment…
- Trial name
- CALDOSE-1 (NCT03341962)
- Testing
- IMU-838
- Where
- 131 sites in United States, Albania and 17 more
- Volunteers
- 263 people
- Sponsor
- Immunic AG
Breast Cancer
A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)
This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus…
- Trial name
- NCT01120184
- Testing
- docetaxel, paclitaxel, pertuzumab
- Where
- 257 sites in United States, Argentina and 36 more
- Volunteers
- 1,095 people
- Sponsor
- Hoffmann-La Roche
Diabetes, Diabetes Mellitus, Type 1
Safety of Insulin Detemir Produced by a New Process as Measured by Antibody Formation in Subjects With Type 1 Diabetes
The trial was conducted in Germany, The Republic of Macedonia, Russian Federation, Serbia and South Africa. The aim of this trial was to make a safety comparison of insulin detemir produced by a new production method (NN729) with…
- Trial name
- NCT00447382
- Testing
- insulin detemir, insulin aspart
- Where
- 5 sites in Germany, North Macedonia and 3 more
- Volunteers
- 330 people
- Sponsor
- Novo Nordisk A/S
Hereditary Angioedema, HAE
Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of oral BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II HAE.
- Trial name
- APeX-2 (NCT03485911)
- Testing
- BCX7353 capsules
- Where
- 47 sites in United States, Austria and 9 more
- Volunteers
- 121 people
- Sponsor
- BioCryst Pharmaceuticals
Hereditary Angioedema, HAE
A Long Term Safety Study of BCX7353 in Hereditary Angioedema
This is an open-label study to evaluate the long term safety and effectiveness of oral treatment with BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II Hereditary Angioedema (HAE).
- Conditions
- Hereditary Angioedema, HAE, Prophylaxis
- Trial name
- APeX-S (NCT03472040)
- Testing
- BCX7353
- Where
- 87 sites in United States, Australia and 18 more
- Volunteers
- 387 people
- Sponsor
- BioCryst Pharmaceuticals
Cardiovascular Diseases, Coronary Disease
International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)
The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic heart disease (SIHD).
- Conditions
- Cardiovascular Diseases, Coronary Disease, Coronary Artery Disease, Heart Diseases
- Trial name
- ISCHEMIA (NCT01471522)
- Testing
- cardiac catheterization, coronary artery bypass graft surgery, percutaneous coronary intervention
- Where
- 320 sites in United States, Argentina and 35 more
- Volunteers
- 5,179 people
- Sponsor
- NYU Langone Health
Lupus Nephritis
Aurinia Renal Response in Active Lupus With Voclosporin
The purpose of this study is to assess the efficacy of voclosporin compared with placebo in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis.
- Trial name
- AURORA (NCT03021499)
- Testing
- Voclosporin
- Where
- 185 sites in United States, Argentina and 29 more
- Volunteers
- 358 people
- Sponsor
- Aurinia Pharmaceuticals Inc.
Hemophilia A or B With Inhibitors
FEIBA Reconstitution Volume Reduction and Faster Infusion Study (FEIBA STAR)
The purpose of this study is to: 1. To evaluate the tolerability and safety of infusing reduced volume Factor Eight Inhibitor Bypassing Activity (FEIBA) at the standard infusion rate of 2 U/kg/min 2.
- Trial name
- NCT02764489
- Testing
- FEIBA
- Where
- 3 sites in Croatia, North Macedonia and 1 more
- Volunteers
- 45 people
- Sponsor
- Baxalta now part of Shire
Diabetes Mellitus, Type 2
A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes
This study will compare the effect of semaglutide once weekly to insulin aspart 3 times daily as add on to metformin and insulin glargine in people with type 2 diabetes.
- Trial name
- SUSTAIN 11 (NCT03689374)
- Testing
- Semaglutide, Insulin aspart, Insulin glargine U100
- Where
- 210 sites in Bosnia and Herzegovina, Bulgaria and 19 more
- Volunteers
- 2,274 people
- Sponsor
- Novo Nordisk A/S
Heart Failure, Type 2 Diabetes Mellitus
Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk
The primary objective of the study was to compare the effect of sotagliflozin to placebo on total occurrences of cardiovascular (CV) death, hospitalization for heart failure [HHF], and urgent visit for heart failure [HF] in…
- Conditions
- Heart Failure, Type 2 Diabetes Mellitus, Chronic Kidney Diseases
- Trial name
- SCORED (NCT03315143)
- Testing
- Sotagliflozin
- Where
- 754 sites in United States, Argentina and 43 more
- Volunteers
- 10,584 people
- Sponsor
- Lexicon Pharmaceuticals
Multiple Sclerosis
BRAVO Study: Laquinimod Double-blind Placebo-controlled Study in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) With a Rater Blinded Reference Arm of Interferon β-1a (Avonex®)
The study aims to compare the effect of daily oral treatment of laquinimod capsules 0.6 milligrams (mg) with the effect of placebo capsules (capsules that contain no active medication) as well as with the effect of an existing…
- Trial name
- BRAVO (NCT00605215)
- Testing
- Laquinimod, Avonex®
- Where
- 170 sites in United States, Bulgaria and 17 more
- Volunteers
- 1,331 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Type 1 Diabetes Mellitus
Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus
Primary Objective: To compare the efficacy of a new formulation of insulin glargine (HOE901-U300) to Lantus in terms of change of HbA1c from baseline to endpoint (month 6) in children and adolescents with type 1 diabetes…
- Trial name
- EDITION JUNIOR (NCT02735044)
- Testing
- Insulin glargine,300 U/mL, Insulin glargine (100 units /mL), Background therapy
- Where
- 107 sites in United States, Argentina and 22 more
- Volunteers
- 463 people
- Sponsor
- Sanofi
Triple-Negative Breast Neoplasms, Breast Neoplasm
Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)
This was a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to carboplatin and…
- Conditions
- Triple-Negative Breast Neoplasms, Breast Neoplasm, Breast Cancer, Triple-Negative Breast Cancer
- Trial name
- NCT02978716
- Testing
- Trilaciclib, Gemcitabine, Carboplatin
- Where
- 54 sites in United States, Belgium and 6 more
- Volunteers
- 102 people
- Sponsor
- G1 Therapeutics, Inc.
Relapsing Multiple Sclerosis
A Study to Evaluate the Long-term Safety, Tolerability and Effect of Daily Oral Laquinimod 0.6 mg on Disease Course in Subjects With Relapsing Multiple Sclerosis
To make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-302 study according to the protocol and to evaluate the long-term safety, tolerability and effect on disease course of daily oral…
- Trial name
- NCT01047319
- Testing
- Laquinimod
- Where
- 144 sites in United States, Bulgaria and 16 more
- Volunteers
- 1,047 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Multiple Sclerosis
The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)
This is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by active treatment, to evaluate the efficacy, safety and tolerability of two doses of oral administration of…
- Trial name
- CONCERTO (NCT01707992)
- Testing
- Laquinimod
- Where
- 284 sites in United States, Austria and 28 more
- Volunteers
- 2,199 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Diabetes, Diabetes Mellitus, Type 2
Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes
This trial is conducted globally. The aim of this trial is to assess the efficacy and safety of liraglutide in the paediatric population in order to potentially address the unmet need for treatment of children and adolescents…
- Trial name
- Ellipse™ (NCT01541215)
- Testing
- liraglutide, metformin
- Where
- 185 sites in United States, Australia and 34 more
- Volunteers
- 135 people
- Sponsor
- Novo Nordisk A/S
Breast Cancer
Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.
- Trial name
- ExteNET (NCT00878709)
- Testing
- neratinib
- Where
- 494 sites in United States, Australia and 38 more
- Volunteers
- 2,840 people
- Sponsor
- Puma Biotechnology, Inc.
Hereditary Angioedema (HAE)
Study of BCX7353 as a Treatment for Attacks of Hereditary Angioedema
This 3-part study will evaluate the efficacy and safety of an oral kallikrein inhibitor, BCX7353, in the treatment angioedema attacks in subjects with Type I or II hereditary angioedema (HAE).
- Trial name
- NCT03240133
- Testing
- BCX7353
- Where
- 24 sites in Austria, Denmark and 10 more
- Volunteers
- 58 people
- Sponsor
- BioCryst Pharmaceuticals
Hereditary Angioedema (HAE)
Efficacy and Safety of BCX7353 to Prevent Angioedema Attacks in Subjects With Hereditary Angioedema
This 3-part study will evaluate the safety and efficacy of an oral treatment, BCX7353, in preventing angioedema attacks in subjects with hereditary angioedema (HAE).
- Trial name
- APeX-1 (NCT02870972)
- Testing
- BCX7353
- Where
- 24 sites in Australia, Austria and 9 more
- Volunteers
- 75 people
- Sponsor
- BioCryst Pharmaceuticals