Clinical trials: Patient Safety
Type 1 Diabetes Mellitus
Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy
This Phase 3 study was intended to demonstrate superiority of either Sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with…
- Trial name
- inTandem2 (NCT02421510)
- Testing
- Sotagliflozin
- Where
- 96 sites in Austria, Belgium and 15 more
- Volunteers
- 782 people
- Sponsor
- Lexicon Pharmaceuticals
Central Nervous System Diseases
Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients
The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of brain or spine diseases in patients of Chinese origin.
- Trial name
- NCT00395460
- Testing
- Gadobutrol (Gadavist, Gadovist, BAY86-4875), Magnevist
- Where
- 4 sites in China
- Volunteers
- 147 people
- Sponsor
- Bayer
Anemia, Iron-Deficiency, Kidney Failure, Chronic
Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents
This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are receiving erythropoietic agents…
- Trial name
- NCT00224042
- Testing
- Sodium Ferric Gluconate complex in sucrose, Ferrous sulfate tablets
- Where
- 24 sites in United States, Puerto Rico
- Volunteers
- 52 people
- Sponsor
- Watson Pharmaceuticals
Hepatocellular Carcinoma (HCC)
A Study of Tislelizumab Versus Sorafenib in Participants With Unresectable Hepatocellular Carcinoma (HCC)
This Phase 3 study was a global, multicenter trial that randomly assigned participants to either tislelizumab or sorafenib as a first-line treatment for adults with advanced liver cancer (hepatocellular carcinoma) that could not…
- Trial name
- NCT03412773
- Testing
- Tislelizumab, Sorafenib
- Where
- 122 sites in United States, China and 9 more
- Volunteers
- 684 people
- Sponsor
- BeiGene
Cystic Fibrosis
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa
The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
- Trial name
- AIR-CF2 (NCT00104520)
- Testing
- AZLI 75 mg two times a day (BID)/three times a day (TID)
- Where
- 56 sites in United States
- Volunteers
- 211 people
- Sponsor
- Gilead Sciences
Nail Psoriasis, Plaque Psoriasis
A Study to Evaluate the Safety and Efficacy of Adalimumab in Subjects With Chronic Plaque Psoriasis and Nail Psoriasis
This study is being conducted to assess the safety and efficacy of adalimumab in participants with nail psoriasis.
- Trial name
- NCT02016482
- Testing
- Adalimumab
- Volunteers
- 217 people
- Sponsor
- AbbVie
Rheumatoid Arthritis
Study of Subcutaneous Golimumab in Chinese Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese patients with rheumatoid arthritis.
- Trial name
- NCT01248780
- Testing
- Golimumab, Methotrexate (MTX)
- Where
- 9 sites in China
- Volunteers
- 264 people
- Sponsor
- Centocor, Inc.
Functional Bowel Disorder
Efficacy and Safety of Mebeverine + Simethicone in Patients With Functional Bowel Disorders
The parallel three-group study of efficacy and safety was planned to investigate the reduction in abdominal pain and bloating during treatment with the fixed-dose combination of Mebeverine + Simethicone versus Duspatalin® and…
- Trial name
- NCT05175131
- Testing
- Mebeverine+Simethicone, Mebeverine, Simethicone
- Where
- Russia
- Volunteers
- 465 people
- Sponsor
- Abbott
Scleroderma, Systemic
Pulmonary Involvement in Scleroderma: A Clinical Study of the Safety and Efficacy of Mycophenolate Mofetil in Scleroderma Patients With Lung Involvement
Researchers from the Division of Pulmonary and Critical Care Medicine at University of California, San Francisco (UCSF) are conducting a study to evaluate whether mycophenolate mofetil (an immunosuppressive medication, trade…
- Trial name
- NCT00333437
- Testing
- Mycophenolate mofetil
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- University of California, San Francisco
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Study of Efficacy and Safety of Twice Daily Oral Iptacopan (LNP023) in Adult PNH Patients Who Are Naive to Complement Inhibitor Therapy
The purpose of this Phase 3 study was to determine whether iptacopan is efficacious and safe for the treatment of Paroxysmal nocturnal hemoglobinuria (PNH) patients who were naïve to complement inhibitor therapy.
- Trial name
- APPOINT-PNH (NCT04820530)
- Testing
- Iptacopan (LNP023)
- Where
- 12 sites in China, France and 6 more
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Diabetes Mellitus, Type 2
A Safety and Efficacy Study of Canagliflozin in Older Patients (55 to 80 Years of Age) With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in older patients (55 to 80 years of age) with type 2 diabetes mellitus (T2DM) with inadequate control…
- Trial name
- NCT01106651
- Testing
- Canagliflozin 100 mg, Canagliflozin 300 mg, Antihyperglycemic agent(s)
- Where
- 86 sites in United States, Australia and 15 more
- Volunteers
- 716 people
- Sponsor
- Janssen Research & Development, LLC
Pompe Disease, Glycogen Storage Disease Type II
An Exploratory Study of the Safety and Efficacy of Prophylactic Immunomodulatory Treatment in Myozyme-naive Cross-Reacting Immunologic Material (CRIM[-]) Patients With Infantile-Onset Pompe Disease
The purpose of this study was to evaluate the efficacy, clinical benefits and safety of a prophylactic immunomodulatory regimen given prior to first treatment with alglucosidase alfa (Myozyme®) in patients with infantile-onset…
- Trial name
- NCT00701129
- Testing
- Alglucosidase Alfa, Methotrexate, Rituximab
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Genzyme, a Sanofi Company
Macular Degeneration, Choroidal Neovascularization
Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization
This study evaluated the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity and anatomic outcomes compared to ranibizumab monotherapy and the durability of response observed in…
- Trial name
- NCT00436553
- Testing
- Verteporfin Photodynamic Therapy, Ranibizumab
- Where
- 43 sites in United States, Canada
- Volunteers
- 321 people
- Sponsor
- Novartis
Acute Respiratory Distress Syndrome
KL₄Surfactant Treatment in Patients With ARDS
Lung wash with KL₄Surfactant of individual lung segments using a bronchoscope compared to usual care alone consisting primarily of assisted (mechanical) ventilation in patients with acute respiratory distress syndrome(ARDS).
- Trial name
- NCT00215553
- Testing
- A.1 Lucinactant, B.3 SoC, A.2 Lucinactant
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Windtree Therapeutics
Primary Myelofibrosis (PMF), Post-Polycythaemia Vera
Study to Assess the Safety of AZD1480 in Patients With Myeloproliferative Diseases
This study is being conducted to test study drug AZD1480 to see how it may work to treat myeloproliferative diseases. The main purpose of this study is to determine the safety and tolerability of AZD1480.
- Conditions
- Primary Myelofibrosis (PMF), Post-Polycythaemia Vera, Essential Thrombocythaemia Myelofibrosis
- Trial name
- NCT00910728
- Testing
- AZD1480
- Where
- 3 sites in United States, France
- Volunteers
- 65 people
- Sponsor
- AstraZeneca
Nocturia
Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray in Elderly Patients With Nocturia
The purpose of this study is to determine if SER120 nasal spray is well tolerated in 75 years or older nocturic patients.
- Trial name
- NCT01259128
- Testing
- SER120 Nasal Spray 500 ng/day, SER120 nasal spray 750 ng/day
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Serenity Pharmaceuticals, Inc.
Chronic Obstructive Pulmonary Disease
A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
This study will evaluate the efficacy, safety, and pharmacokinetics of astegolimab in combination with standard of care chronic obstructive pulmonary disease (COPD) maintenance therapy in patients with COPD who are former or…
- Trial name
- NCT05037929
- Testing
- Astegolimab
- Where
- 193 sites in United States, Argentina and 22 more
- Volunteers
- 1,334 people
- Sponsor
- Genentech, Inc.
Pain, Postoperative
Safety and Clinical Utility Study of SSEC Fentanyl 40 mcg for Acute Post-op Pain Management in Pediatric Participants
The objective of this study is to evaluate the safety and clinical utility of the active, SSEC fentanyl 40 micrograms (mcg) for the management of acute, postoperative pain in pediatric participants.
- Trial name
- NCT02395653
- Testing
- fentanyl
- Where
- 10 sites in United States
- Volunteers
- 71 people
- Sponsor
- The Medicines Company
Hip Fractures
Acute Hip Fracture Study in Patients 65 Years or Greater
This is a randomized, double-blind, parallel group, placebo-controlled, multicenter study to investigate the safety, tolerability, and efficacy of VK5211 after 12 weeks of treatment.
- Trial name
- NCT02578095
- Testing
- VK5211
- Where
- 21 sites in United States, Hungary and 2 more
- Volunteers
- 108 people
- Sponsor
- Viking Therapeutics, Inc.
Overactive Bladder Syndrome (OABS)
SMP-986 Phase 2 Proof of Concept in Patients With Overactive Bladder Syndrome (OABS)
SMP-986 is a compound being developed for the treatment of overactive bladder syndrome (OABS). This clinical study is designed to test the hypothesis that SMP-986 at doses of 20mg, 40mg, 80mg or 120mg provides greater symptom…
- Trial name
- NCT00409539
- Testing
- SMP-986
- Where
- 69 sites in United States, Estonia and 7 more
- Volunteers
- 550 people
- Sponsor
- Sumitomo Pharma America, Inc.
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