Clinical trials: Medication Safety
Essential Hypertension
A Study to Evaluate the Effectiveness and Safety of a Fixed Dose Combination of Azilsartan Medoxomil and Chlorthalidone in Patients With High Blood Pressure Who do Not Achieve Target Blood Pressure Following Treatment With Azilsartan Medoxomil Alone
The purpose of this study is to evaluate the efficacy and safety of the fixed dose combinations of azilsartan medoxomil plus chlorthalidone (40/12.5 and 40/25 mg), once daily, in participants with grades 2 or 3 essential…
- Trial name
- NCT01456169
- Testing
- Azilsartan medoxomil - chlorthalidone
- Where
- 108 sites in Bulgaria, Estonia and 12 more
- Volunteers
- 507 people
- Sponsor
- Takeda
Rheumatoid Arthritis
Long-term Treatment Study of Certolizumab Pegol (CDP870) as Add-on Medication to Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients
The objectives of this study are to evaluate the safety and efficacy of certolizumab pegol as add-on medication to methotrexate over the long term in Japanese RA patients transferred from Study 275-08-001 (NCT00791999), and to…
- Trial name
- NCT00851318
- Testing
- Certolizumab pegol, Methotrexate
- Where
- 8 sites in Japan
- Volunteers
- 285 people
- Sponsor
- Astellas Pharma Inc
Tardive Dyskinesia (TD)
Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia
This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the persistence of effect of valbenazine 40 mg and 80 mg.
- Trial name
- NCT03891862
- Testing
- Valbenazine
- Where
- 43 sites in United States, Puerto Rico
- Volunteers
- 135 people
- Sponsor
- Neurocrine Biosciences
Osteoarthritis (OA)
Safety, Tolerability and Preliminary Efficacy of Multiple Intra-articular Injections of LRX712 in Patients With Knee OA
This study explored the preliminary efficacy of multiple intra-articular injections of LRX712 by evaluating the ability of the drug to restore structural integrity of articular cartilage.
- Trial name
- NCT04097379
- Testing
- LRX712
- Where
- Netherlands
- Volunteers
- 45 people
- Sponsor
- Novartis Pharmaceuticals
Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS)
A Study Evaluating Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine
The purpose of this study is to check how soticlestat impacts symptoms of Dravet syndrome [DS] and Lennox-Gastaut syndrome [LGS] in participants who have been exposed to fenfluramine.
- Trial name
- NCT06422377
- Testing
- Soticlestat
- Where
- Denmark
- Volunteers
- 1 people
- Sponsor
- Takeda
Coronary Restenosis
SELUTION SLR™ 014 In-stent Restenosis
Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial. Subjects with previous bare-metal stent (BMS) or Drug-Eluting Stent (DES) and qualifying evidence for In-stent Restenosis (ISR) will…
- Trial name
- SELUTION4ISR (NCT04280029)
- Testing
- SELUTION SLR 014 DEB, Standard of Care
- Where
- 48 sites in United States, Belgium and 5 more
- Volunteers
- 418 people
- Sponsor
- M.A. Med Alliance S.A.
Schizophrenia
Fingolimod in Schizophrenia Patients
This will be a single site safety and proof of concept study conducted at the Indiana University Psychotic Disorders Program. Forty subjects with schizophrenia or schizoaffective disorders will be randomized 1:1 to double-blind…
- Trial name
- STEP (NCT01779700)
- Testing
- Fingolimod
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Indiana University
Antipsychotic-induced Weight Gain (AIWG)
A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adults With Schizophrenia or Bipolar Disorder Treated With Antipsychotic Medications
This phase 2, double blind, placebo-controlled, randomized study is to assess the safety, efficacy, and pharmacokinetics (PK) of miricorilant (CORT118335) in obese adults with schizophrenia or bipolar disorder treated with…
- Trial name
- GRATITUDE (NCT03818256)
- Testing
- Miricorilant
- Where
- 27 sites in United States
- Volunteers
- 71 people
- Sponsor
- Corcept Therapeutics
Essential Hypertension
Safety and Tolerability of Azilsartan Medoxomil Plus Chlorthalidone Compared to Olmesartan Medoxomil Plus Hydrochlorothiazide in Participants With Essential Hypertension
The purpose of this study is to compare the safety and tolerability of azilsartan medoxomil plus chlorthalidone, once daily (QD), versus olmesartan medoxomil-hydrochlorothiazide in adults with essential hypertension.
- Trial name
- NCT00996281
- Testing
- Azilsartan medoxomil and chlorthalidone, Olmesartan medoxomil and hydrochlorothiazide
- Where
- 26 sites in Austria, Germany and 3 more
- Volunteers
- 837 people
- Sponsor
- Takeda
Kidney Transplantation
Concentration Controlled Everolimus With Reduced Dose Cyclosporine Versus Mycophenolate Mofetil With Standard Dose Cyclosporine in de Novo Renal Transplant Adult Recipients Treated With Basiliximab and Corticosteroids
The 12 Month Core Study (CRAD001A1202) was designed to evaluate the efficacy and safety comparing concentration-controlled everolimus (1.5 mg/day starting dose) with reduced dose cyclosporine and corticosteroids versus 2 g/day…
- Trial name
- NCT00658320
- Testing
- Everolimus, Mycophenolate mofetil (MMF), Basiliximab
- Where
- Japan
- Volunteers
- 122 people
- Sponsor
- Novartis
Healthy Volunteers
Phase 1, TAK-648, Single-Rising Dose Study
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of TAK-648 when administered as a single oral dose of TAK-648 solution at escalating dose levels in healthy participants.
- Trial name
- NCT02684396
- Testing
- TAK-648
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Takeda
Rheumatoid Arthritis, Ankylosing Spondylitis
99mTc-rhAnnexin V-128 a Phase I/IIa Study in Patients With Rheumatoid Arthritis (RA) or Ankylosing Spondylitis (AS)
This was a monocentric, open label, Phase I-IIa study. Eligible patients who signed the ICF received two single intravenous (IV) bolus of the imaging agent 99mTc-rhAnnexin V-128.
- Trial name
- NCT02328027
- Testing
- 99mTc-rhAnnexin V-128
- Where
- Switzerland
- Volunteers
- 16 people
- Sponsor
- Advanced Accelerator Applications
Achondroplasia
A Clinical Trial to Evaluate the Safety and Efficacy of BMN 111 in Infants and Young Children With Achondroplasia
Study 111-206 is a Phase 2 randomized, double-blind, placebo-controlled clinical trial of BMN 111 in infants and young children with a diagnosis of achondroplasia.
- Trial name
- NCT03583697
- Testing
- BMN 111
- Where
- 16 sites in United States, Australia and 2 more
- Volunteers
- 75 people
- Sponsor
- BioMarin Pharmaceutical
Advanced Parkinson's Disease
A Study to Assess the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease (PD) and Persistent Motor Complications, Despite Optimized Treatment With Available Anti-Parkinsonian Medications
The primary objective of this study is to measure the efficacy of ABT-SLV187 in subjects with advanced Parkinson's disease.
- Trial name
- NCT01960842
- Testing
- Levodopa-carbidopa intestinal gel, CADD-Legacy® 1400 ambulatory infusion pump, PEG tube
- Volunteers
- 31 people
- Sponsor
- AbbVie
Coronary Artery Disease
A Study of 123I-CMICE-013 Radiopharmaceutical in Healthy Volunteers
The need exists for alternatives to 99mTc based perfusion radiotracers for cardiac patient management. An alternative radiotracer, I123-CMICE-013, has been developed at the Canadian Molecular Imaging Center of Excellence (C-MICE)…
- Trial name
- CMICE (NCT01558362)
- Testing
- 123I-CMICE-013
- Where
- Canada
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Ottawa Heart Institute Research Corporation
Presbyopia, Refractive Error
Phase 3 Evaluation of the Safety and Efficacy of LNZ100 & LNZ101 for the Treatment of Presbyopia
Phase 3 study to evaluate the safety and effectiveness of LNZ100 \& LNZ101 for the treatment of Presbyopia.
- Conditions
- Presbyopia, Refractive Error, Eye Diseases, Near Vision
- Trial name
- CLARITY 1 (NCT05656027)
- Testing
- Aceclidine+Brimonidine combination ophthalmic solution, Aceclidine ophthalmic solution, Brimonidine
- Where
- 25 sites in United States
- Volunteers
- 469 people, healthy volunteers welcome
- Sponsor
- LENZ Therapeutics, Inc
Genital Herpes
Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes
The aim of the study is to evaluate the safety and efficacy of "AIC316 (pritelivir)" 100 mg once daily compared to valacyclovir 500 mg once daily for the prevention of HSV-2 genital shedding.
- Trial name
- NCT01658826
- Testing
- AIC316, Valacyclovir
- Where
- 4 sites in United States
- Volunteers
- 91 people
- Sponsor
- AiCuris Anti-infective Cures AG
Mild Cognitive Impairment Due to Alzheimer's Disease
Biomarker Qualification for Risk of Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease (AD) and Safety and Efficacy Evaluation of Pioglitazone in Delaying Its Onset
The purpose of this study is to qualify the biomarker risk algorithm for prognosis of the risk of developing Mild Cognitive Impairment due to Alzheimer's Disease (MCI-AD), and also to evaluate the efficacy of pioglitazone…
- Trial name
- TOMMORROW (NCT01931566)
- Testing
- Pioglitazone
- Where
- 55 sites in United States, Australia and 3 more
- Volunteers
- 3,494 people, healthy volunteers welcome
- 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
Bioavailability
Bioavailability, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets in Healthy Participants
The purpose of this study is to assess the pharmacokinetics (PK) and Pharmacodynamics (PD) of dexlansoprazole delayed-release orally disintegrating (OD) tablets administered on the tongue and swallowed without water.
- Trial name
- NCT02064907
- Testing
- Dexlansoprazole Delayed Release Orally Disintegrating Tablets, Dexlansoprazole Delayed Release Capsules
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Takeda
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