Clinical trials: RANDOMIZED
Rheumatoid Arthritis
Study of the Efficacy and Safety of BCD-089 in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
BCD-089 is the original therapeutic monoclonal antibody binding the alpha subunit of the IL-6 receptor. The aim of the study is to demonstrate the efficacy and safety of BCD-089 in combination with methotrexate in patients with…
- Trial name
- SOLAR (NCT04227366)
- Testing
- BCD-089, Methotrexat
- Where
- Russia
- Volunteers
- 154 people
- Sponsor
- Biocad
Hypercholesterolemia and Hyperlipidemia, Supplementation
Evaluation of the Effects of Two Dietary Supplement Formulations on the Lipid Profile in Mild Hypercholesterolemia
A single-center, randomized, parallel-group, double-blind, placebo-controlled clinical study followed by an open-label phase to evaluate the effects of a new formulation of a supplement on lipid profile in subjects with mild…
- Trial name
- NCT06810466
- Testing
- Test Product A, Test Product B
- Where
- Italy
- Volunteers
- 99 people
- Sponsor
- IBSA Farmaceutici Italia Srl
Fetal Membranes, Premature Rupture
Removal Versus Retention of Cerclage in Preterm Premature Rupture of Membranes (PPROM)
The purpose of this study is to determine whether retention of cervical cerclage after PPROM improves latency (without a significant increase in chorioamnionitis) and lessens neonatal morbidity.
- Trial name
- PROMCerclage (NCT00201656)
- Testing
- Retention of Cerclage, Removal of Cerclage, Removal vs. Retention of Cervical Cerclage
- Where
- 23 sites in United States
- Volunteers
- 58 people
- Sponsor
- Obstetrix Medical Group
Human Microbiome
Oral Pomegranate Extract on the Microbiome and Skin Biophysical Properties
Pomegranate extract (Pomella) is well known for its antioxidant properties due to its phenolic compounds. It has also been shown to increase the amount of short chain fatty acid producing Lactobacillus and Bifidobacteria genera.
- Trial name
- NCT04596722
- Testing
- Pomella
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Integrative Skin Science and Research
Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease
Addressing Dementia Via Agitation-Centered Evaluation
This is a multi-center, randomized, double-blind, placebo-controlled study, to assess the efficacy and safety of AXS-05 in the treatment of agitation in patients with Alzheimer's disease.
- Conditions
- Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation,Psychomotor
- Trial name
- ADVANCE (NCT03226522)
- Testing
- AXS-05, Bupropion
- Where
- 78 sites in United States, Australia
- Volunteers
- 366 people
- Sponsor
- Axsome Therapeutics, Inc.
Mixed Dyslipidemia
Phase 2 Dose-Finding Study Evaluating the Efficacy and Safety of EDP167 in Adults With Mixed Dyslipidemia
EDP167 is a double-stranded small interfering RNA (siRNA) drug targeting angiopoietin-like 3 protein (ANGPTL3), which may bring benefits for patients with dyslipidemia conditions.
- Trial name
- NCT07799129
- Testing
- EDP167 100mg, EDP167 200mg, EDP167 300mg
- Where
- 2 sites in China
- Volunteers
- 144 people
- Sponsor
- Eddingpharm (Zhuhai) Co., Ltd.
Chronic Systolic Heart Failure
Evaluate the Effect of Injectable Neucardin on the Cardiac Function of Subjects With Chronic Systolic Heart Failure
A multi-center, randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the effect of injectable Neucardin on the heart function in male patients with NT-proBNP ≤ 1700 pg/ml and female patients with…
- Trial name
- NCT04468529
- Testing
- Recombinant human Neuregulin for injection
- Where
- 29 sites in China
- Volunteers
- 154 people
- Sponsor
- Zensun Sci. & Tech. Co., Ltd.
Coronary Artery Disease
Multicenter Study to Evaluate the Procedural Safety and Efficacy of ELCA in CAD
This is a Prospective, Open label, Non-randomized, Single-Arm, Multicenter Study to Evaluate the Procedural Safety and Efficacy of ELCA® in Treatment of Patients with Single or Multivessel Coronary Artery Disease (CAD).
- Trial name
- ELCA-CAD (NCT03284229)
- Testing
- Excimer Laser Coronary Atherectomy
- Where
- 5 sites in India
- Volunteers
- 28 people
- Sponsor
- Spectranetics Corporation
Antibody-mediated Rejection
A Study to Evaluate the Safety and Tolerability of Efgartigimod PH20 SC Given by Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection (AMR)
The purpose of this study is to assess the safety, tolerability, and efficacy of efgartigimod PH20 SC given by a prefilled syringe in participants with Antibody-Mediated Rejection (AMR) after kidney transplantation.
- Trial name
- Shamrock (NCT06503731)
- Testing
- Efgartigimod PH20 SC - prefilled syringe
- Where
- 23 sites in United States, Austria and 6 more
- Volunteers
- 33 people
- Sponsor
- argenx
Rhinoconjunctivitis
Multicenter Trial of Immunotherapy With House Dust Mite Allergoid
Multicenter Immunotherapy House Dust Mite Allergoid
- Trial name
- ACRI (NCT00540631)
- Testing
- specific immunotherapy with Acaroid, subcutaneously, Up-titration till strength B 0.6 mL (6000 TU)
- Where
- Germany
- Volunteers
- 108 people
- Sponsor
- Allergopharma GmbH & Co. KG
Alzheimer's Disease
AC-1204 Long-term Efficacy Response Trial (ALERT Protocol)
The study will evaluate the safety \& efficacy of AC-1204, a ketogenic compound, administered orally on a daily basis for 6 months.
- Trial name
- ALERT (NCT01211782)
- Testing
- caprylic triglyceride, long-chain triglyceride
- Where
- United States
- Sponsor
- Cerecin
RSV Infection
Safety and Immunogenicity Study of SCB-1019T in Children
This phase 1 study in Australia will evaluate the safety, reactogenicity and immunogenicity of the Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T) in children 2-<6 years of age.
- Trial name
- NCT06666179
- Testing
- low dose SCB-1019T, adjuvanted low dose SCB-1019T, high dose SCB-1019T
- Where
- Australia
- Volunteers
- healthy volunteers welcome
- Sponsor
- Clover Biopharmaceuticals AUS Pty
Cataract
Accommodation Measurements After Bilateral Implantation of an Aspheric Accommodating Lens and Monofocal Aspheric Lenses
The objective of this study is to demonstrate the correlation of near vision and changes in higher order aberrations following lens extraction and to characterize the defocus curves of Crystalens® AO™ intraocular lens (IOL)…
- Trial name
- NCT01241279
- Testing
- Crystalens AO, SoftPort LI61AO
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Bausch & Lomb Incorporated
Hormone-sensitive, HER-2 Negative Metastatic Breast Cancer
Study of MEDI-573 Plus Standard Endocrine Therapy for Women With Hormone-sensitive Metastatic Breast Cancer
Study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573 in combination with an aromatase inhibitor (AI) in adult subjects with HR+, HER2-negative MBC.
- Trial name
- NCT01446159
- Testing
- MEDI-573, Aromatase Inhibitor
- Where
- 71 sites in United States, Belgium and 9 more
- Volunteers
- 188 people
- Sponsor
- MedImmune LLC
Norovirus
Phase 1 Norwalk Vaccine Study
Randomized, double blind, multi-site, study in healthy adults, comparing safety and immunogenicity of two dosage levels of Norwalk VLP Vaccine with adjuvant/excipients and with placebo controls Primary Objective: Safety as…
- Trial name
- NCT00806962
- Testing
- Adjuvant/Excipients, Norwalk VLP Vaccine
- Where
- 4 sites in United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- LigoCyte Pharmaceuticals, Inc.
RAS Wild-type Metastatic Colorectal Cancer
Pharmacokinetic (PK) Study of QL1203 and Vectibix® for the Treatment of RAS Wild-type Metastatic Colorectal Cancer
This is a randomized, double-blind, parallel-controlled, multicenter clinical trial to evaluate the pharmacokinetic similarity between QL1203 and Vectibix® in patients with RAS wild-type metastatic colorectal cancer.
- Trial name
- NCT07829588
- Testing
- QL1203 + mFOLFOX6, Vectibix®+ mFOLFOX6
- Volunteers
- 136 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Healthy
Bioequivalence Study of Ramipril 10 mg Capsules Under Fed Conditions
The study was conducted as an open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioavailability study comparing ramipril 10 mg capsules of Ohm Laboratories Inc., with Altace®…
- Trial name
- NCT00879788
- Testing
- Ramipril 10mg capsules
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Respiratory Viral Infection
A Clinical Trial Evaluating the Safety and Efficacy of AP1189 Versus Placebo as an add-on to Standard of Care in Participants With Respiratory Insufficiency Expected to be Caused by Infection With Respiratory Viruses
A clinical study to evaluate the efficacy and safety of once daily oral dosing of 100 mg AP1189 or placebo administered for 14 days, as an add-on to standard of care (SOC) in participants with respiratory insufficiency expected…
- Trial name
- RESPIRE (NCT07633288)
- Testing
- AP1189, 100 mg
- Where
- 11 sites in Bosnia and Herzegovina, Montenegro and 2 more
- Volunteers
- 96 people
- Sponsor
- SynAct Pharma Aps
Active Rheumatoid Arthritis
A Study to Assess the Safety and Efficacy of Different Doses of ELV001 to Treat Active Rheumatoid Arthritis in Patients With an Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition (START SYNERGY)
This is a Phase 2 randomized, double-blind, placebo-controlled study with a total duration of 32 weeks from Screening to End-of-Study (EOS) Visit. Approximately 180 participants are planned to be enrolled.
- Trial name
- NCT07409103
- Testing
- ELV001 25 mg, ELV001 75 mg, ELV001 125 mg
- Where
- 34 sites in United States, Serbia and 1 more
- Volunteers
- 180 people
- Sponsor
- Elevara Medicines Limited
Dry Eye Disease
Study to Evaluate the Efficacy and Safety of CKD-352
The purpose of this study is to compare the efficacy and safety of CKD-352 in patients with dry eye disease
- Trial name
- NCT04548427
- Testing
- CKD-352, Diquafosol Sodium 3%
- Where
- South Korea
- Volunteers
- 283 people
- Sponsor
- Chong Kun Dang Pharmaceutical
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