Clinical trials: Patient Safety
Diabetes Mellitus, Type 2
Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes
The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum…
- Trial name
- NCT01778049
- Testing
- BI 10773, BI 10773 / BI 1356
- Where
- 114 sites in United States, Argentina and 9 more
- Volunteers
- 708 people
- Sponsor
- Boehringer Ingelheim
Depressive Disorder, Major
A Study to Test the Effect of Different Doses of BI 1358894 and Quetiapine in People With Depression
This study is open to adults with depression (major depressive disorder) for whom standard treatment with antidepressants alone does not work sufficiently.
- Trial name
- NCT04521478
- Testing
- BI 1358894, Quetiapine
- Where
- 120 sites in United States, Argentina and 12 more
- Volunteers
- 389 people
- Sponsor
- Boehringer Ingelheim
Acute Coronary Syndrome (ACS)
Safety Study of Apixaban in Recent Acute Coronary Syndrome
The purpose of this clinical research study is to determine whether apixaban will be safe in people who have recently had unstable angina or a heart attack.
- Trial name
- NCT00313300
- Testing
- Apixaban
- Where
- 151 sites in United States, Austria and 12 more
- Volunteers
- 1,741 people
- Sponsor
- Bristol-Myers Squibb
Alzheimer's Disease
Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of TB006 in Participants With Alzheimer's Disease
Part 1 of this study will be conducted to determine the safety, tolerability, and pharmacokinetic (PK) profile of multiple doses of TB006, as well as the maximum tolerated dose of TB006, and to assess the immunogenicity of TB006…
- Trial name
- NCT05074498
- Testing
- TB006
- Where
- 18 sites in United States
- Volunteers
- 154 people
- Sponsor
- TrueBinding, Inc.
Wound Infection, Abscess
Oritavancin Versus IV Vancomycin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infection
The purpose of this Phase 3 trial is to evaluate the efficacy, safety, and tolerability of oritavancin in ABSSSIs, including those caused by MRSA and to evaluate the potential economic benefit of oritavancin administered as a…
- Conditions
- Wound Infection, Abscess, Systemic Inflammation, Cellulitis
- Trial name
- SOLO II (NCT01252732)
- Testing
- Single-Dose IV Oritavancin Diphosphate, IV Vancomycin
- Where
- United States
- Volunteers
- 1,019 people
- Sponsor
- Melinta Therapeutics, Inc.
COVID-19, Cardiovascular Diseases
Cannabidiol in Patients With COVID-19 and Cardiovascular Disease or Risk Factors
Non-critical patients, hospitalized within the previous 24 hours who tested positive for COVID-19 and have a prior history of cardiovascular disease (CVD) and/or significant risk factors for CVD will be treated for 28 days.
- Conditions
- COVID-19, Cardiovascular Diseases, Cardiovascular Risk Factor
- Trial name
- NCT04615949
- Testing
- Cannabidiol, pharmaceutically produced with < 5 ppm THC
- Where
- 20 sites in United States, Brazil and 1 more
- Volunteers
- 90 people
- Sponsor
- Cardiol Therapeutics Inc.
Non-Small Cell Lung Cancer, Metastatic Colorectal Cancer, Metastatic Non Small Cell Lung Cancer, Metastatic Cancers, Melanoma
A Study of the Safety, Tolerability, and Effects of Cobimetinib and GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors
This is a two-stage dose-escalation study to assess the safety, tolerability and effects of oral dosing of cobimetinib and GDC-0994 administered in combination in patients with histologically confirmed, locally advanced, or…
- Trial name
- NCT02457793
- Testing
- Cobimetinib, GDC-0994
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- Genentech, Inc.
Aortic Stenosis
PERIGON Japan Trial
The purpose of this study is to evaluate the safety and effectiveness of the 17mm MDT-2215 aortic valve bioprosthesis.
- Trial name
- NCT02686814
- Testing
- 17mm MDT-2215 aortic valve bioprosthesis
- Where
- 10 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Medtronic Cardiac Surgery
Epidermal Nevus Syndrome
A Trial to Assess the Safety and Efficacy of KRN23 in Epidermal Nevus Syndrome (ENS)
KRN23 is a fully human immunoglobulin monoclonal antibody (mAb) that binds to and inhibits the activity of fibroblast growth factor 23 (FGF23), leading to an increase in serum phosphorus levels.
- Trial name
- ENS (NCT04320316)
- Testing
- Crysvita (burosumab-twza) Treatment
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Alabama at Birmingham
Hepatitis B
Study of ARO-HBV in Normal Adult Volunteers and Patients With Hepatitis B Virus (HBV)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of ARO-HBV in healthy adult volunteers and participants with hepatitis B virus (HBV).
- Trial name
- NCT03365947
- Testing
- ARO-HBV, Sterile Normal Saline (0.9% NaCl), JNJ-56136379
- Where
- 7 sites in Australia, Hong Kong and 1 more
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
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.
Uveitis
Efficacy and Safety of Adalimumab in Patients With Active Uveitis
A study comparing the safety and efficacy of adalimumab compared with placebo in patients with active uveitis.
- Trial name
- VISUAL l (NCT01138657)
- Testing
- Adalimumab, Prednisone
- Volunteers
- 239 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Hypertension
A Study to Investigate the Magnitude and Duration of Response of MK0954 Compared to Placebo in Patients With Hypertension (0954-021)(COMPLETED)
The purpose of this study was to evaluate the magnitude and durations of the antihypertensive effects of losartan using ambulatory blood pressure monitoring (ABPM), and to evaluate the safety of losartan 50 and 100 mg doses…
- Trial name
- NCT00886600
- Testing
- losartan potassium, hydrochlorothiazide (HCTZ)
- Volunteers
- 122 people
- Sponsor
- Merck Sharp & Dohme LLC
Pathological Myopia
Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia
This study is designed to evaluate the efficacy and safety of two different dosing regimens of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in patients with visual impairment due to…
- Trial name
- NCT01217944
- Testing
- Ranibizumab, Verteporfin PDT
- Where
- 74 sites in Austria, Canada and 18 more
- Volunteers
- 277 people
- Sponsor
- Novartis Pharmaceuticals
Acute Myeloid Leukemia
Study of Milademetan in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
This is a Phase 1, multicenter, open-label study to evaluate safety, tolerability and pharmacokinetics of milademetan in Japanese patients with relapsed or refractory acute myeloid leukemia.
- Trial name
- NCT03671564
- Testing
- Milademetan
- Where
- 8 sites in Japan
- Volunteers
- 14 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Squamous Cell Carcinoma, Head and Neck Cancer
Study of Safety and Efficacy of Talimogene Laherparepvec With Cisplatin and Radiotherapy for Treatment of Locally Advanced Head and Neck Cancer
This study is being conducted to learn about the safety and risks of using talimogene laherparepvec to treat patients with head and neck cancer and to see if talimogene laherparepvec and chemoradiation together can destroy the…
- Trial name
- NCT01161498
- Testing
- Talimogene Laherparepvec, Radiation, Cisplatin
- Where
- 6 sites in United States, United Kingdom
- Volunteers
- 5 people
- Sponsor
- BioVex Limited
Major Depressive Disorder, Vasomotor Symptoms
Desvenlafaxine Succinate (Pristiq): Postmarketing Surveillance Study Among Filipino Patients
This is a non-interventional study to review safety data on administration of desvenlafaxine succinate among Filipino patients with MDD and VMS per usual clinical practice within the first three years post commercial distribution.
- Trial name
- NCT01353963
- Testing
- desvenlafaxine succinate
- Where
- 3 sites in Philippines
- Volunteers
- 13 people
- Sponsor
- Pfizer
Alzheimer's Disease, Central Nervous System Diseases
Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Alzheimer's Disease
This study is being conducted to determine the safety, tolerability, and pharmacokinetics (PK) of three different doses of an investigational medication, EVP-6124, in individuals with mild to moderate Alzheimer's disease who are…
- Trial name
- NCT00766363
- Testing
- EVP-6124 (0.1 mg/day), EVP-6124 (0.3 mg/day), EVP-6124 (1.0 mg/day)
- Where
- 4 sites in United States
- Volunteers
- 49 people
- Sponsor
- FORUM Pharmaceuticals Inc
Atherosclerosis
A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients
The primary objective of this study is to examine the effects of SB-480848 on plasma lipoprotein associated phospholipase A2 (Lp-PLA2) activity in dyslipidemic patients during a 4-week treatment with SB-480848.
- Trial name
- NCT00734032
- Testing
- SB480848 40mg EC Tablet, SB480848 80mg EC Tablet, SB480848 160mg EC Tablet
- Where
- 7 sites in Japan
- Volunteers
- 107 people
- Sponsor
- GlaxoSmithKline
Chemotherapy-induced Neutropenia
Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Breast Cancer Patients
The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastim and daily dosing of filgrastim for prevention of neutropenia in patients receiving AT (docetaxel 75 mg/m2 + doxorubicin 50 mg/m2).
- Trial name
- NCT02104830
- Testing
- Empegfilrastim 6 mg, Filgrastim, Empegfilrastim 7.5 mg
- Where
- 13 sites in Russia
- Volunteers
- 135 people
- Sponsor
- Biocad
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