Clinical trials: Medication Safety
Major Depressive Disorder
Vortioxetine, 5, 10, and 20 mg, Relapse Prevention Study in Adults With Major Depressive Disorder (MDD)
The purpose of this study is to evaluate the efficacy of vortioxetine (5, 10, and 20 mg) versus placebo during the first 28 weeks of the 32-week double-blind treatment period in the prevention of relapse in participants with MDD…
- Trial name
- NCT02371980
- Testing
- Vortioxetine
- Where
- 79 sites in United States
- Volunteers
- 1,106 people
- Sponsor
- Takeda
Rheumatoid Arthritis
A Study of a Novel Investigational Drug in Rheumatoid Arthritis Patients (MK-0873-012)(COMPLETED)
This study will look at whether this new drug is effective in the treatment of rheumatoid arthritis, and at whether it is safe and well-tolerated by participants with the disease.
- Trial name
- NCT00132769
- Testing
- MK-0873
- Volunteers
- 106 people
- Sponsor
- Merck Sharp & Dohme LLC
Solid Tumours
Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment
This is a 2-part study in patients with advanced solid tumours. Part A will investigate the PK of olaparib in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function; Part B will allow…
- Trial name
- NCT01894243
- Testing
- Olaparib tablet dosing
- Where
- 12 sites in Czechia, France and 3 more
- Volunteers
- 31 people
- Sponsor
- AstraZeneca
Hypertriglyceridemia
Long-term Efficacy and Safety Study of TAK-085 in Participants With Hypertriglyceridemia
The purpose of this study is to determine the safety and efficacy of TAK-085, once daily (QD) or twice daily (BID), compared to ethyl eicosapentaenoate (EPA-E), three times daily (TID) in participants with hypertriglyceridemia…
- Trial name
- NCT01350999
- Testing
- omega-3-acid ethyl esters 90 (TAK-085), Eicosapentaenoic acid-ethyl (EPA)
- Volunteers
- 503 people
- Sponsor
- Takeda
Neoplasms, Breast Neoplasms
This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer
This is a study in adult patients with different types of cancer. The purpose of this study is to find a safe dose of: Xentuzumab in combination with abemaciclib Xentuzumab in combination with abemaciclib and hormonal therapies…
- Trial name
- NCT03099174
- Testing
- Xentuzumab, Abemaciclib, Letrozole
- Where
- 30 sites in United States, Denmark and 5 more
- Volunteers
- 133 people
- Sponsor
- Boehringer Ingelheim
Rheumatoid Arthritis
(C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid Arthritis
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Escalating Doses of SAN-300 in Patients with Active Rheumatoid Arthritis with Inadequate Response to Disease-Modifying Anti-rheumatic Drug(s).
- Trial name
- NCT02047604
- Testing
- SAN-300 0.5 mg/kg QW, SAN-300 1.0 mg/kg QW, SAN-300 2.0 mg/kg QOW
- Where
- 12 sites in United States
- Volunteers
- 41 people
- Sponsor
- Bausch Health Americas, Inc.
Achondroplasia
A Study to Evaluate the Efficacy and Safety of BMN 111 in Children With Achondroplasia
The intent and design of this Phase 3 study is to assess BMN 111 as a therapeutic option for the treatment of children with Achondroplasia.
- Trial name
- NCT03197766
- Testing
- BMN 111
- Where
- 24 sites in United States, Australia and 5 more
- Volunteers
- 121 people
- Sponsor
- BioMarin Pharmaceutical
Hepatitis C, Chronic
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Enrolled in a Methadone Maintenance Treatment Program.
This study will evaluate the safety and tolerability of PEGASYS plus ribavirin in previous intravenous (iv) drug users who have CHC and are currently enrolled in a methadone maintenance treatment program.
- Trial name
- NCT00087594
- Testing
- peginterferon alfa-2a [Pegasys], ribavirin
- Where
- 7 sites in United States
- Volunteers
- 48 people
- Sponsor
- Hoffmann-La Roche
Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL)
A Study of TAK-007 in Adults With Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL)
This study has 2 parts. The main aim of Part 1 is to check for side effects from TAK-007 in adults with relapsed or refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL), The main aim of Part 2 is to learn whether lymphoma disease…
- Trial name
- NCT05020015
- Testing
- TAK-007, Chemotherapy Agents
- Where
- 15 sites in United States
- Volunteers
- 27 people
- Sponsor
- Takeda
Overactive Bladder
An Extension Study to Examine the Safety and Tolerability of a New Drug in Patients With Symptoms of Overactive Bladder (OAB).
This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in participants with OAB for up to 52 weeks.
- Trial name
- Empowur (NCT03583372)
- Testing
- Vibegron, Tolterodine Tartrate ER
- Where
- 107 sites in United States
- Volunteers
- 506 people
- Sponsor
- Urovant Sciences GmbH
Benign Prostatic Hyperplasia (BPH)
A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo
A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.
- Trial name
- NCT00224107
- Testing
- Silodosin
- Where
- 43 sites in United States
- Volunteers
- 461 people
- Sponsor
- Watson Pharmaceuticals
Complex Regional Pain Syndrome
Study of TAK-935 as an Adjunctive Therapy in Adult Participants With Complex Regional Pain Syndrome (CRPS)
The purpose of this study is to investigate the effect of soticlestat (TAK-935) on calculated 24-hour average pain intensity by the numeric pain scale (NPS).
- Trial name
- NCT03990649
- Testing
- Soticlestat
- Where
- 3 sites in United Kingdom
- Volunteers
- 24 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Severe Hepatic Impairment
Pharmacokinetics, Safety and Tolerability of Vortioxetine in Normal Hepatic Function or Severe Hepatic Impairment
The purpose of this study is to evaluate the pharmacokinetics of vortioxetine and its metabolites Lu AA34443 and Lu AA39835 following a single oral dose administration of vortioxetine 5 mg in participants with severe hepatic…
- Trial name
- NCT02170220
- Testing
- Vortioxetine
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Takeda
Colitis, Ulcerative
A Study to Assess Clinical Effectiveness and Safety of Vedolizumab Intravenous in Real World Clinical Practice in Ulcerative Colitis (UC) Korean Participants
The purpose of this study is to assess the clinical effectiveness by the clinical response at 6 weeks and the safety of vedolizumab intravenous in UC Korean participants.
- Trial name
- NCT03535649
- Where
- 15 sites in South Korea
- Volunteers
- 105 people
- Sponsor
- Takeda
Coronary Artery Disease, Atherosclerosis, Coronary
Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
The objective of this post-approval study is to confirm that the clinical performance of the Orsiro stent in a real-world setting is similar to the clinical performance observed for Orsiro in the BIOFLOW-V Investigational Device…
- Conditions
- Coronary Artery Disease, Atherosclerosis, Coronary, Myocardial Ischemia, Ischemic Heart Disease
- Trial name
- BIOFLOW-VII (NCT04175626)
- Testing
- Orsiro DES
- Where
- 33 sites in United States
- Volunteers
- 556 people
- Sponsor
- Biotronik, Inc.
Narcolepsy Type 2
A Study of TAK-861 in Participants With Narcolepsy Type 2
The main aim is to evaluate the effect of TAK-861 on symptoms of narcolepsy, including excessive daytime sleepiness (EDS) as measured by sleep latency from the Maintenance of Wakefulness Test (MWT).
- Trial name
- NCT05687916
- Testing
- TAK-861 2 mg, TAK-861 2 mg and 5 mg
- Where
- 56 sites in United States, Australia and 10 more
- Volunteers
- 71 people
- Sponsor
- Takeda
Chronic Kidney Disease, Hypertension
Patiromer in the Treatment of Hyperkalemia in Patients With Hypertension and Diabetic Nephropathy (AMETHYST-DN)
This study determined the optimal starting dose of patiromer in treating hyperkalemia in participants with hypertension and diabetic nephropathy who were already receiving ACEI and/or ARB drugs, with or without spironolactone.
- Conditions
- Chronic Kidney Disease, Hypertension, Hyperkalemia
- Trial name
- AMETHYST-DN (NCT01371747)
- Testing
- patiromer, losartan, spironolactone
- Where
- 43 sites in Croatia, Georgia and 3 more
- Volunteers
- 324 people
- Sponsor
- Relypsa, Inc.
Healthy Volunteers
Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 1 of 4)
The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of several blood thinner drugs on laboratory tests. The study also is evaluating the blood levels of PRT064445 given at different doses.
- Trial name
- NCT01758432
- Testing
- PRT064445/Apixaban
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Portola Pharmaceuticals
Safety Issues, Pharmacokinetics
Effect of Clarithromycin on PK of Linaprazan, Linaprazan on PK of Clarithromycin and Linaprazan on PK of Midazolam
This is a phase I, open-label, fixed sequence design, drug-drug-interaction (DDI) study divided in 2 parts. Part I is designed to evaluate whether concomitant treatment with linaprazan glurate and clarithromycin, a strong…
- Conditions
- Safety Issues, Pharmacokinetics, Drug Interaction, Tolerability
- Trial name
- NCT05633147
- Testing
- Linaprazan glurate, Drug drug interaction (DDI) - Clarithromycin (Part I), Drug drug interaction (DDI) - Midazolam (Part 2)
- Where
- Sweden
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Cinclus Pharma Holding AB
Diabetic Macular Edema
A Study to Learn How Safe the Study Drug Intravitreal (Given by an Injection Into the Eye) Aflibercept is in Participants in India With Diabetic Macular Edema
Researchers are looking for a better way to treat people who have diabetic macular edema (DME). Diabetic macular edema (DME) is a complication of diabetes.
- Trial name
- VISION-AF (NCT05511038)
- Testing
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- Where
- 10 sites in India
- Volunteers
- 100 people
- Sponsor
- Bayer
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