Clinical trials: Patient Safety
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Efficacy and Safety Study of I10E in Treatment of Patients With CIDP
Primary objective: To assess the efficacy of I10E in improving the disability of patients with CIDP. Secondary objective: To assess the safety of I10E in patients with CIDP.
- Trial name
- PRISM (NCT02293460)
- Testing
- I10E
- Where
- 33 sites in France, Italy and 4 more
- Volunteers
- 44 people
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
Non-Small Cell Lung Cancer, Urothelial Cancer
A Study of Avelumab in Combination With Axitinib In Non-Small Cell Lung Cancer (NSCLC) or Urothelial Cancer (Javelin Medley VEGF)
This is a Phase 2 study to evaluate the safety and efficacy of avelumab in combination with axitinib in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior platinum…
- Trial name
- NCT03472560
- Testing
- Avelumab (MSB0010718C), Axitinib (AG-013736)
- Where
- 39 sites in United States, Hungary and 6 more
- Volunteers
- 61 people
- Sponsor
- Pfizer
Primary Open Angle Glaucoma
Post Market Study of the InnFocus MicroShunt
Prospective, multicentric, single arm post market study to gather safety and effectiveness data on the CE Marked InnFocus MicroShunt (MIDI Arrow) device in primary open angle glaucoma patients
- Trial name
- NCT02177123
- Testing
- InnFocus MicroShunt implantation
- Where
- 6 sites in France, Netherlands and 2 more
- Volunteers
- 107 people
- Sponsor
- InnFocus Inc.
Hypercholesterolemia or Combined Dyslipidemia
Study to Compare the Efficacy and Safety of Pitavastatin and Pravastatin in Elderly Patients
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of pravastatin in elderly patients
- Trial name
- NCT00257686
- Testing
- Pitavastatin, Pravastatin
- Where
- 62 sites in Denmark, Germany and 3 more
- Volunteers
- 962 people
- Sponsor
- Kowa Research Europe
Diagnostic Self Evaluation, Central Nervous System Diseases
Safety and Efficacy Evaluation of DOTAREM® in MRI of Central Nervous System (CNS) Lesions
The purpose of this study is to look at the safety (what are the side effects)and efficacy (how well does it work) of Dotarem® when used in taking images of the brain / spine.
- Trial name
- SENTIO (NCT01211873)
- Testing
- Dotarem (gadoterate meglumine), Magnevist (gadopentetate dimeglumine)
- Where
- 52 sites in United States, Argentina and 9 more
- Volunteers
- 416 people
- Sponsor
- Guerbet
Gastrointestinal Tumors, Colorectal Adenocarcinomas
Study to Test the Safety and Tolerability of PF-07062119 in Patients With Selected Advanced or Metastatic Gastrointestinal Tumors.
A phase 1, open-label, dose escalation and expansion study of PF-07062119 in patients with selected advanced or metastatic gastrointestinal tumors
- Conditions
- Gastrointestinal Tumors, Colorectal Adenocarcinomas, Gastric Adenocarcinomas, Esophageal Adenocarcinomas
- Trial name
- NCT04171141
- Testing
- PF-07062119, Anti-PD1, Anti-VEGF
- Where
- 19 sites in United States, Australia and 1 more
- Volunteers
- 79 people
- Sponsor
- Pfizer
Chronic Obstructive Pulmonary Disease
Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to evaluate, after 1 week of dosing, the efficacy and safety of PT003 compared with its individual components (PT001 and PT005), placebo and two active comparators to demonstrate superiority of the…
- Trial name
- NCT01085045
- Testing
- PT003 MDI, PT005 MDI, Tiotropium bromide 18 μg (Spiriva Handihaler®)
- Where
- 16 sites in United States, Australia and 1 more
- Volunteers
- 118 people
- Sponsor
- Pearl Therapeutics, Inc.
Duchenne Muscular Dystrophy
Efficacy and Safety Study of WVE-210201 (Suvodirsen) With Open-label Extension in Ambulatory Patients With Duchenne Muscular Dystrophy
This is a Phase 2/3, multicenter, randomized, double-blind, placebo-controlled study with an open-label extension period to evaluate the safety and efficacy of WVE-210201 (suvodirsen) in ambulatory male pediatric patients with…
- Trial name
- DYSTANCE 51 (NCT03907072)
- Testing
- WVE-210201 (suvodirsen)
- Where
- 22 sites in United States, Belgium and 6 more
- Volunteers
- 6 people
- Sponsor
- Wave Life Sciences USA, Inc.
Gastric, or Gastroesophageal Junction Adenocarcinoma
Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma
This study was designed to compare the efficacy and safety of tislelizumab plus chemotherapy versus placebo plus chemotherapy as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or…
- Trial name
- NCT03777657
- Testing
- Tislelizumab, Cisplatin, Oxaliplatin
- Where
- 149 sites in United States, China and 11 more
- Volunteers
- 997 people
- Sponsor
- BeiGene
Cystic Fibrosis
Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study
Protocol 0000498: Multicenter, open label study to evaluate the effect of sustained RELiZORB (immobilized lipase) cartridge use during enteral feeding on fat absorption, as well as safety and tolerability of sustained RELiZORB…
- Trial name
- ASSURE (NCT02750501)
- Testing
- RELiZORB (immobilized lipase) cartridge, Impact Peptide 1.5
- Where
- 10 sites in United States
- Volunteers
- 49 people
- Sponsor
- Alcresta Therapeutics, Inc.
Chronic Idiopathic Urticaria
A Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)
The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment…
- Trial name
- NCT01292473
- Testing
- Omalizumab
- Where
- 61 sites in United States, Denmark and 6 more
- Volunteers
- 323 people
- Sponsor
- Genentech, Inc.
Chronic Heart Failure With Preserved Ejection Fraction
Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF
The primary hypothesis in this trial is that the treatment with vericiguat 10 mg or 15 mg in patients with HFpEF improves the KCCQ PLS (Kansas City Cardiomyopathy Questionnaire Physical limitation score) compared to placebo after…
- Trial name
- VITALITY-HFpEF (NCT03547583)
- Testing
- Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets
- Where
- 177 sites in United States, Argentina and 19 more
- Volunteers
- 789 people
- Sponsor
- Bayer
Portal Hypertension
Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension
The primary purpose of this study is to determine the efficacy and safety of cobiprostone (at two dose levels) as compared to placebo for lowering portal hypertension.
- Trial name
- NCT00737594
- Testing
- Cobiprostone
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Sucampo Pharma Americas, LLC
Hypertension and Cardiovascular Risk Factors
Real Life Experience With Caduet In Patients With Cardiovascular Risk Factors
To assess the effect of single pill therapy on the management of hypertension and other cardiovascular risk factors (e.g., dyslipidemia) in Indian patients in whom the treating doctor has already considered that the…
- Trial name
- EXCEL (NCT00579254)
- Testing
- CADUET (AMLODIPINE 5 mg/ATORVASTATIN 10 mg or 20 mg)
- Volunteers
- 112 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Hypertension
Effectiveness and Safety of Combination of Nebivolol and Amlodipine in Hypertensive Patients Versus Each Monotherapy
Study to assess the anti-hypertensive efficacy and safety of the extemporaneous combination of Nebivolol 5 mg in combination with Amlodipine 5 mg or AML 10 mg in lowering the sitting diastolic BP after 8 weeks of treatment…
- Trial name
- Botticelli (NCT05513937)
- Testing
- Nebivolol, Amlodipine
- Where
- Bulgaria
- Volunteers
- 301 people
- Sponsor
- Menarini International Operations Luxembourg SA
Colorectal Cancer
A Study of Nanrilkefusp Alfa (SOT101) in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer
The primary objective of the study is to estimate the antitumor efficacy of nanrilkefusp alfa (SOT101) in combination with cetuximab in RAS wild-type colorectal cancer.
- Trial name
- NCT05619172
- Testing
- Nanrilkefusp alfa, Cetuximab
- Where
- 8 sites in Belgium, France and 1 more
- Volunteers
- 16 people
- Sponsor
- SOTIO Biotech AG
Diabetes Mellitus, Type 2
A Research Study to See How a New Weekly Insulin, Insulin Icodec When Given Along With Semaglutide Helps in Reducing the Blood Sugar Level in Patients With Type 2 Diabetes
This study looks at how a new medicine insulin icodec helps in reducing blood sugar levels when given along with semaglutide in patients with type 2 diabetes.
- Trial name
- NCT05813912
- Testing
- Insulin Icodec, Semaglutide
- Where
- 39 sites in Czechia, Malaysia and 3 more
- Volunteers
- 148 people
- Sponsor
- Novo Nordisk A/S
Type 2 Diabetes Mellitus
Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the safety and efficacy of TA-7284 as monotherapy or combination therapy with other oral anti-hyperglycaemic agent in Japanese patients with Type 2 diabetes mellitus on 52 weeks oral…
- Trial name
- NCT01387737
- Testing
- TA-7284-Low, TA-7284-High
- Where
- 7 sites in Japan
- Volunteers
- 1,299 people
- Sponsor
- Tanabe Pharma Corporation
Overweight and Obesity
Phase 1b/2a Study to Evaluate Safety and Efficacy of Setmelanotide in Obese Patients
The purpose of this study is to evaluate the effects of a new daily subcutaneous (SC) injectable formulation of setmelanotide (RM-493) in healthy participants with obesity on mean percent body weight loss and other weight loss…
- Trial name
- NCT02041195
- Testing
- Setmelanotide
- Where
- 2 sites in United States
- Volunteers
- 99 people
- Sponsor
- Rhythm Pharmaceuticals, Inc.
Hepatitis C, Chronic
A Phase III Study of TMC435 in Treatment-naive, Genotype 1, Hepatitis C-infected Patients
The purpose of this study is to evaluate the efficacy and safety of TMC435 compared with placebo in combination with peginterferon alfa-2a (pegIFN alfa-2a) and ribavirin in treatment-naive patients with chronic genotype 1…
- Trial name
- NCT01292239
- Testing
- TMC435, Peginterferon alfa-2a (pegIFN alfa-2a), Ribavirin (RBV)
- Where
- 28 sites in Japan
- Volunteers
- 183 people
- Sponsor
- Janssen Pharmaceutical K.K.
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