Clinical trials: Drug Safety
Corneal Endothelial Dystrophy, Fuchs Endothelial Corneal Dystrophy
A Phase 1/ Phase 2 Study of TTHX1114(NM141)
Prospective, multicenter, randomized, masked, vehicle-controlled, dose-escalation study
- Conditions
- Corneal Endothelial Dystrophy, Fuchs Endothelial Corneal Dystrophy, Pseudophakic Bullous Keratopathy, Endothelial Dysfunction
- Trial name
- INTREPID (NCT04520321)
- Testing
- TTHX1114(NM141)
- Where
- 8 sites in United States
- Volunteers
- 22 people
- Sponsor
- Trefoil Therapeutics, Inc.
Hypervolemic and Euvolemic Hyponatremia
Samsca Post Marketing Surveillance Study
This Post-Marketing Surveillance will be conducted in accordance with the local regulation of New Drug Re-examination. The surveillance will be conducted for 6 years of the re-examination period (01Sep2011~31Aug2017).
- Trial name
- Samsca PMS (NCT02722863)
- Where
- 4 sites in South Korea
- Volunteers
- 908 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
Diabetes Mellitus, Type 2
A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Semaglutide (COMBINE 2)
This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to semaglutide taken once a week in people with type 2 diabetes.
- Trial name
- COMBINE 2 (NCT05259033)
- Testing
- IcoSema, Semaglutide 1 mg
- Where
- 193 sites in United States, Brazil and 13 more
- Volunteers
- 683 people
- Sponsor
- Novo Nordisk A/S
Rheumatoid Arthritis
A Study to Evaluate the Efficacy and Safety of CAM-3001 (Drug) in Subjects With Rheumatoid Arthritis
The primary objectives of this study is to assess the safety, tolerability and efficacy of multiple doses of the mavrilimumab (CAM-3001) administered subcutaneously in subjects with moderately active Rheumatoid Arthritis (RA).
- Trial name
- NCT01050998
- Testing
- Mavrilimumab 10 mg, Mavrilimumab 30 mg, Mavrilimumab 50 mg
- Where
- 55 sites in Bulgaria, Czechia and 9 more
- Volunteers
- 516 people
- Sponsor
- MedImmune LLC
Viral Respiratory Tract Infection
Safety and Tolerability of Single and Multiple Doses of Neumifil
This is a Phase 1, single-centre, randomised, placebo-controlled first in human study in healthy subjects. The study will assess the safety and tolerability of single-ascending (Part A) and multiple-ascending (Part B) doses of…
- Trial name
- NCT05093530
- Testing
- Neumifil
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Pneumagen Ltd.
Smoking
Nicotine Pharmacokinetic and Pharmacodynamics Profile, Safety and Tolerability of P3L
The purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD, i.e., subjective effects) profiles, and the safety and tolerability of the nicotine-containing aerosol delivered by Platform 3 Liquid…
- Trial name
- NCT02532374
- Testing
- Nicorette® inhalator, P3L
- Where
- New Zealand
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
COVID-19
Study to Evaluate the Effects of RO7496998 (AT-527) in Non-Hospitalized Adult and Adolescent Participants With Mild or Moderate COVID-19
This study will evaluate the efficacy, safety, antiviral activity, and pharmacokinetics of study drug RO7496998 (AT-527) compared to placebo in non-hospitalized adult and adolescent participants with mild to moderate coronavirus…
- Trial name
- MORNINGSKY (NCT04889040)
- Testing
- RO7496998
- Where
- 50 sites in Argentina, Belgium and 10 more
- Volunteers
- 216 people
- Sponsor
- Hoffmann-La Roche
Diabetes Mellitus
Long-term Safety of Alogliptin in Patients With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the long-term safety of alogliptin, once daily (QD), following participation in 1 of 7 controlled studies in patients with type 2 diabetes mellitus.
- Trial name
- NCT00306384
- Testing
- Alogliptin
- Where
- 114 sites in United States, Argentina and 10 more
- Volunteers
- 3,323 people
- Sponsor
- Takeda
TTR-mediated Amyloidosis, Amyloidosis, Hereditary
APOLLO: The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis
The purpose of this study is to evaluate the safety and efficacy of patisiran (ALN-TTR02) in patients with transthyretin (TTR) mediated amyloidosis.
- Conditions
- TTR-mediated Amyloidosis, Amyloidosis, Hereditary, Amyloid Neuropathies, Familial, Familial Amyloid Polyneuropathies
- Trial name
- NCT01960348
- Testing
- patisiran (ALN-TTR02), Sterile Normal Saline (0.9% NaCl)
- Where
- 52 sites in United States, Argentina and 19 more
- Volunteers
- 225 people
- Sponsor
- Alnylam Pharmaceuticals
Infertility
Efficacy and Safety of Crinone Versus Combination Medication (ACCESS)
The study to compare to the efficacy and safety of Crinone versus combination medication in infertile women receive frozen-thawed embryo transfer (FET) in artificial cycles (AC).
- Trial name
- NCT03858049
- Testing
- Crinone, Duphaston
- Where
- China
- Volunteers
- 172 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Acute Pain
A Phase 2 Study to Evaluate Analgesic Effect of IV CR845 For Pain Following Bunionectomy Surgery
This is a single-center, randomized, double blind, placebo controlled, parallel group proof of concept study to evaluate the analgesic efficacy as well as the safety, tolerability and pharmacokinetic profile of CR845 in patients…
- Trial name
- NCT01789476
- Testing
- CR845
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Cara Therapeutics, Inc.
Neoplasms, Breast Neoplasms
A Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The First-Line Treatment Of Postmenopausal Japanese Patients With ER (+) HER2 (-) Advanced Breast Cancer
This study is comprised of two portions: a Phase 1 portion and a Phase 2 portion. The Phase 1 portion is a single-country, non-randomized, open label, clinical trial which will evaluate the safety, tolerability, preliminary…
- Trial name
- NCT01684215
- Testing
- PD-0332991, letrozole
- Where
- 16 sites in Japan
- Volunteers
- 61 people
- Sponsor
- Pfizer
Generalized Anxiety Disorder
Efficacy of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder
The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily (QD), in adults with generalized anxiety disorder.
- Trial name
- NCT00730691
- Testing
- Vortioxetine, Duloxetine
- Where
- 66 sites in United States
- Volunteers
- 781 people
- Sponsor
- Takeda
Prostatic Cancer
Quinacrine Treatment in Patients With Androgen-Independent Prostate Cancer
The purpose of this study is to determine whether quinacrine is effective in the treatment of Androgen-Independent Prostate Cancer.
- Trial name
- NCT00417274
- Testing
- Quinacrine
- Volunteers
- 31 people
- Sponsor
- Cleveland BioLabs
Candidemia, Mycoses
Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis
The purpose of this pivotal study is to determine if intravenous Rezafungin is efficacious and safe in the treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by optional oral fluconazole).
- Conditions
- Candidemia, Mycoses, Fungal Infection, Invasive Candidiases
- Trial name
- ReSTORE (NCT03667690)
- Testing
- Rezafungin for Injection, Caspofungin, Fluconazole
- Where
- 132 sites in United States, Argentina and 16 more
- Volunteers
- 199 people
- Sponsor
- Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Rheumatoid Arthritis
To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)
Primary Objective: To demonstrate that sarilumab added to disease modifying anti-rheumatic drugs (DMARDs) were effective for: reduction of signs and symptoms at Week 24 and improvement of physical function at Week 12 in…
- Trial name
- NCT01709578
- Testing
- Sarilumab, hydroxychloroquine, methotrexate
- Where
- 196 sites in United States, Argentina and 28 more
- Volunteers
- 546 people
- Sponsor
- Sanofi
Hepatic Cirrhosis, Liver Fibrosis
A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C
This is a study of experimental medication BMS-986263 in adult patients with advanced hepatic fibrosis (scar tissue in the liver caused by inflammation that is far on in progress) after the patient is cured of hepatitis C (an…
- Trial name
- NCT03420768
- Testing
- BMS-986263
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Bristol-Myers Squibb
Atrial Fibrillation
Safety Study on Stopping Anticoagulation Medication in Patients With a History of Atrial Fibrillation
The purpose of this study is to determine whether it is safe to stop anticoagulation medication in patients with a history of atrial fibrillation (AF) based on information from a pacemaker or implantable cardioverter…
- Trial name
- TACTIC AF (NCT01650298)
- Testing
- Drug (Direct thrombin or Factor Xa inhibitor)
- Where
- 10 sites in United States
- Volunteers
- 64 people
- Sponsor
- Abbott Medical Devices
Psoriatic Arthritis
Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis (PsA)
The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis who have not been previously treated with DMARDs.
- Trial name
- PALACE4 (NCT01307423)
- Testing
- Apremilast 20mg, Apremilast 30mg
- Where
- 118 sites in United States, Australia and 16 more
- Volunteers
- 529 people
- Sponsor
- Amgen
Type 2 Diabetes Mellitus
Long-term Safety Study of Alogliptin Used in Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan
The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and Thiazolidine administered once daily (QD) for 40 consecutive weeks in participants who completed a phase 2/3 Thiazolidine add on study.
- Trial name
- NCT01318122
- Testing
- Alogliptin and pioglitazone
- Volunteers
- 336 people
- Sponsor
- Takeda
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