Clinical trials: Drug Safety
Migraine Disorders
Migraine Study in Adolescent Patients
This study was designed to determine how well the combination medication, sumatriptan and naproxen sodium, treats migraine headache in adolescents 12-17 years old
- Trial name
- NCT00843024
- Testing
- Sumatriptan and Naproxen Sodium
- Where
- 79 sites in United States
- Volunteers
- 589 people
- Sponsor
- GlaxoSmithKline
Chronic Renal Failure, Chronic Kidney Disease
Safety and Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis
The purpose of this study was to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease, who are not on dialysis and not on erythropoiesis stimulating agent (ESA)…
- Conditions
- Chronic Renal Failure, Chronic Kidney Disease, Anemia
- Trial name
- PEARL 2 (NCT00598442)
- Testing
- peginesatide, Darbepoetin alfa
- Where
- 64 sites in United States, Bulgaria and 8 more
- Volunteers
- 493 people
- Sponsor
- Affymax
Diabetes, Diabetes Mellitus, Type 2
Evaluation of the Glycaemic Control With Insulin Detemir as an add-on to Current Oral Anti-diabetic Drug Treatment in Subjects With Type 2 Diabetes in Korea
This trial is conducted in Asia. This trial aims for evaluating the glycaemic control, measured as glycosylated haemoglobin (Hb1Ac), of once daily insulin detemir as an add-on to oral antidiabetic drug (OAD) in subjects with type…
- Trial name
- NCT00455858
- Testing
- insulin detemir
- Where
- South Korea
- Volunteers
- 87 people
- Sponsor
- Novo Nordisk A/S
Carcinoma of Urinary Tract, Urethral Carcinoma
Study of Ramucirumab or Icrucumab (IMC-18F1) With Docetaxel or Docetaxel Alone as Second-Line Therapy in Participants With Bladder,Urethra, Ureter, or Renal Pelvis Carcinoma
This multicenter trial will enroll participants with metastatic transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis who have had disease progression on first-line platinum-based chemotherapy regimens.
- Conditions
- Carcinoma of Urinary Tract, Urethral Carcinoma, Carcinoma of Ureter, Carcinoma of Renal Pelvis
- Trial name
- NCT01282463
- Testing
- Docetaxel, Ramucirumab DP, Icrucumab
- Where
- 32 sites in United States, Canada
- Volunteers
- 148 people
- Sponsor
- Eli Lilly and Company
Rheumatoid Arthritis
A Study of Tocilizumab (RoActemra) in Tocilizumab-Naive Participants With Rheumatoid Arthritis and Inadequate Response to Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) and/or Biologic Therapy
This two part, multi-center, open-label, single-arm study will evaluate the efficacy and safety of tocilizumab as a monotherapy or in combination with methotrexate or other conventional synthetic disease modifying antirheumatic…
- Trial name
- TOSCA (NCT02001987)
- Testing
- Tocilizumab, Methotrexate, csDMARDs
- Where
- 32 sites in France
- Volunteers
- 139 people
- Sponsor
- Hoffmann-La Roche
Advanced Solid Tumors, Advanced Recurrent Ovarian Tumors
A Study to Evaluate the Safety and Antitumor Activity in Subjects With Advanced Solid Tumors
To determine the maximum tolerated dose or optimal biological dose, and the safety profile of MEDI3617 when given as a single-agent or in combination with other chemotherapeutic agents in subjects with advanced solid malignancies…
- Trial name
- NCT01248949
- Testing
- MEDI3617, Bevacizumab, Paclitaxel
- Where
- 10 sites in United States
- Volunteers
- 162 people
- Sponsor
- MedImmune LLC
HIV
A Phase 1 Trial to Evaluate CAP256V2LS in Healthy Adults
Background: HIV is a serious disease with no cure or vaccine to prevent it. Using antibodies could be a way to prevent HIV infection. Antibodies are made by the human body to fight germs.
- Trial name
- VRC 611 (NCT04408963)
- Testing
- VRC-HIVMAB0102-00-AB
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pulmonary TB, Pulmonary Tuberculosis
Phase 2 Trial Assessing TBAJ876 or Bedaquiline, With Pretomanid and Linezolid in Adults With Drug-sensitive Pulmonary Tuberculosis
The goal of this clinical trial is to evaluate 3 dose levels of TBAJ876 for 8 weeks in combination with pretomanid and linezolid, compared to 8 weeks of Isoniazid, rifampicin, pyrazinamide and ethambutol (2HRZE), in adult…
- Conditions
- Pulmonary TB, Pulmonary Tuberculosis, Drug Sensitive Tuberculosis
- Trial name
- NCT06058299
- Testing
- sorfequiline, Pretomanid, Linezolid
- Where
- 22 sites in Georgia, Philippines and 3 more
- Volunteers
- 309 people
- Sponsor
- Global Alliance for TB Drug Development
Metastatic Cancer, Solid Tumors
Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors
This study is an open-label Phase 1/Phase 2 evaluation of INCB001158 as a single agent and in combination with immune checkpoint therapy in patients with advanced/metastatic solid tumors.
- Conditions
- Metastatic Cancer, Solid Tumors, Colorectal Cancer (CRC), Gastric Cancer
- Trial name
- NCT02903914
- Testing
- INCB001158, Pembrolizumab
- Where
- 20 sites in United States, Italy and 2 more
- Volunteers
- 260 people
- Sponsor
- Incyte Corporation
Healthy Volunteers, Tension-type Headache
A Study to Describe Pain Intensity, Pain Relief and Safety of Neosaldina in the Treatment of Tension-type Headaches (TTH) in Healthy Participants
The purpose of this study is to describe pain relief in TTH with Neosaldina treatment.
- Trial name
- NCT03666858
- Where
- 5 sites in Brazil
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- Takeda
Diabetes, Diabetes Mellitus, Type 2
A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs
This trial is conducted in Europe and North America. The aim of the trial is to compare the efficacy and safety of insulin degludec and insulin glargine 300 units/mL in subjects with type 2 diabetes mellitus inadequately treated…
- Trial name
- CONCLUDE (NCT03078478)
- Testing
- Insulin degludec, Insulin glargine
- Where
- 229 sites in United States, Canada and 10 more
- Volunteers
- 1,609 people
- Sponsor
- Novo Nordisk A/S
Hypertension
Efficacy and Safety Study of Azilsartan Medoxomil Compared to Ramipril for Treating Essential Hypertension
The purpose of this study is to determine the efficacy and safety of azilsartan medoxomil, once daily (QD), compared to ramipril for treating Essential Hypertension.
- Trial name
- NCT00760214
- Testing
- Azilsartan medoxomil, Ramipril
- Where
- 72 sites in Bulgaria, Estonia and 8 more
- Volunteers
- 885 people
- Sponsor
- Takeda
Central Nervous System
Pharmacokinetics, Efficacy, and Safety of Perampanel Oral Suspension on Seizure Frequency in Pediatric Subjects Maintained on One to Three Stable Antiepileptic Drugs
This study is designed to evaluate the pharmacokinetics, efficacy, and safety of perampanel oral suspension on seizure frequency in pediatric participants maintained on one to three stable antiepileptic drugs
- Trial name
- NCT01527006
- Testing
- perampanel
- Where
- 23 sites in United States
- Volunteers
- 63 people
- Sponsor
- Eisai Inc.
Childhood Absence Epilepsy
Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures
The primary purpose of this study is to assess the long-term safety and tolerability of Cannabidiol Oral Solution (CBD) in pediatric participants with treatment-resistant childhood absence seizures.
- Trial name
- NCT03355300
- Testing
- Cannabidiol Oral Solution
- Where
- 9 sites in United States
- Volunteers
- 11 people
- Sponsor
- Radius Pharmaceuticals, Inc.
Glycemic Control
Comparison of Fasiglifam (TAK-875) to Placebo and Sitagliptin in Combination With Metformin in Participants With Type 2 Diabetes
The purpose of this study is to evaluate the efficacy of 2 doses of TAK-875 (25 mg and 50 mg), once daily (QD), plus metformin compared to placebo plus metformin and sitagliptin plus metformin on lowering blood sugar.
- Trial name
- NCT01549964
- Testing
- Fasiglifam (TAK-875), Sitagliptin
- Where
- 160 sites in United States, Australia and 9 more
- Volunteers
- 916 people
- Sponsor
- Takeda
Neoplasms, Advanced Solid
A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of Trebananib (AMG 386 ) in Adult Japanese Participants With Advanced Solid Tumors
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic (PK) profile of trebananib (AMG 386) after intravenous administration in adult Japanese participants with advanced solid tumors.
- Trial name
- NCT02525536
- Testing
- Trebananib 3 mg/kg, Trebananib 10 mg/kg, Trebananib 30 mg/kg
- Volunteers
- 18 people
- Sponsor
- Takeda
Type 2 Diabetes Mellitus
Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes
The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with oral antihyperglycaemic agent in patients with type 2 Diabetes for 52 weeks administration.
- Trial name
- NCT01301833
- Testing
- teneligliptin, glinide, biguanide
- Where
- Japan
- Volunteers
- 462 people
- Sponsor
- Tanabe Pharma Corporation
Neovascular Age-related Macular Degeneration (nAMD)
Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Vial Kit
This is a single-arm, open-label study where all patients will receive a single injection of SOK583A1 (40 mg/mL) provided in a vial kit at Baseline. The total study duration for the individual participant is approximately 31 days.
- Trial name
- NCT05282004
- Testing
- SOK583A1
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- Sandoz
Gastric Ulcer, Duodenal Ulcer
Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer
The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily…
- Conditions
- Gastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis, Osteoarthritis
- Trial name
- NCT00595517
- Testing
- Esomeprazole 20 mg
- Where
- 3 sites in Japan
- Volunteers
- 395 people
- Sponsor
- AstraZeneca
Rheumatoid Arthritis
A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs)
This observational study will evaluate the safety and efficacy of tocilizumab in participants with active moderate to severe RA and an inadequate response to non-biologic DMARDs.
- Trial name
- NCT01617005
- Testing
- Tocilizumab
- Where
- Montenegro
- Volunteers
- 50 people
- Sponsor
- Hoffmann-La Roche
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