Clinical trials: High Risk Medications
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
Bipolar Disorder
High Deductible Health Plans and Bipolar Disorder
Using eleven years (2004-2014) of claims data from the largest US commercial health insurer, the investigators will assess the impact of switching into high-deductible health plans (HDHPs) on outcomes for patients with bipolar…
- Trial name
- NCT02560701
- Testing
- Patient Interview
- Volunteers
- 350,823 people, healthy volunteers welcome
- Sponsor
- Harvard Pilgrim Health Care
Liver Tumour
Targeted Chemotherapy Using Focused Ultrasound for Liver Tumours
This proof of concept study proposes targeted delivery of a broad-spectrum cytotoxic agent (doxorubicin), via a specially formulated LTSL (ThermoDox®) activated by mild hyperthermia, by using focused ultrasound (FUS), to achieve…
- Trial name
- TARDOX (NCT02181075)
- Testing
- ThermoDox® (LTLD), Focused Ultrasound of Target Liver Tumour, Pre-LTLD Biopsy of Target Liver Tumour
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- University of Oxford
Pancreatic Neoplasms, Pancreatic Cancer
Clinical Trial of High-dose Vitamin C for Advanced Pancreatic Cancer
This is a phase II study. It is designed to provide information about if high-dose ascorbate (vitamin C) increases survival for pancreatic cancer patients.
- Trial name
- PACMAN-II (NCT01515046)
- Testing
- Gemcitabine with escalating ascorbic acid
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Joseph J. Cullen
Acute Lymphoblastic Leukemia (ALL)
Glucarpidase Effect on Severe Delayed HDM-clearance in Children Treated With High-dose Mtx in ALL
Early intervention in children and adolescents who experience delayed MTX-clearance and renal dysfunction in ALL treatments with the enzyme Glucarpidase which rapidly hydrolyses MTX to non-toxic metabolites to avoid life…
- Trial name
- NOPHOCPG2 (NCT01305655)
- Testing
- Glucarpidase
- Where
- 5 sites in Denmark, Finland and 3 more
- Volunteers
- 47 people
- Sponsor
- Nordic Society for Pediatric Hematology and Oncology
Risk Behavior, HIV/AIDS
Testing an Integrated Bio-Behavioral Primary HIV Prevention Intervention Among High-Risk People Who Use Drugs
This study will evaluate the efficacy and cost-effectiveness of CHRP-BB - an integrated bio-behavioral approach that incorporates the use of PrEP - with an evidence-based behavioral approach aimed at enhancing PrEP adherence and…
- Conditions
- Risk Behavior, HIV/AIDS, Medication Adherence, Substance Abuse
- Trial name
- CHRP-BB (NCT03282890)
- Testing
- CHRP-BB
- Where
- United States
- Volunteers
- 237 people
- Sponsor
- University of Connecticut
Opioid-Related Disorders, Opiate Addiction
Discontinuation vs Continuation of Long-term Opioid Therapy in Suboptimal and Optimal Responders With Chronic Pain
The purpose of this study is to evaluate the effect on pain intensity (PI) of structured discontinuation of long-term opioid analgesic therapy compared to continuation of opioid therapy in Suboptimal and Optimal Responders to…
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02741076
- Testing
- Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
- Where
- 61 sites in United States
- Volunteers
- 44 people
- Sponsor
- Member Companies of the Opioid PMR Consortium
Myelodysplastic Syndrome
Study of Vadastuximab Talirine (SGN-CD33A; 33A) in Combination With Azacitidine in Patients With Previously Untreated Higher Risk MDS
This is a phase 1/2 study to evaluate the combination of vadastuximab talirine (SGN-CD33A; 33A) and azacitidine in subjects with previously untreated International Prognostic Scoring System (IPSS) Intermediate-2 or high risk…
- Trial name
- NCT02706899
- Testing
- vadastuximab talirine, Azacitidine
- Where
- 34 sites in United States
- Volunteers
- 19 people
- Sponsor
- Seagen Inc.
Myelodysplastic Syndrome, Leukemia, Myelomonocytic, Chronic
Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML)
The purpose of this study is to determine whether the combination of pevonedistat and azacitidine improves event-free survival (EFS) when compared with single-agent azacitidine.
- Conditions
- Myelodysplastic Syndrome, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
- Trial name
- PANTHER (NCT03268954)
- Testing
- Azacitidine, Pevonedistat
- Where
- 242 sites in United States, Australia and 18 more
- Volunteers
- 454 people
- Sponsor
- Takeda
Prostatic Neoplasms, Neoplasm Metastasis
A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)
The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months.
- Conditions
- Prostatic Neoplasms, Neoplasm Metastasis, Urogenital Neoplasms, Physiological Effects of Drugs
- Trial name
- CYCLONE 3 (NCT05288166)
- Testing
- Abemaciclib, Abiraterone, Prednisone or Prednisolone
- Where
- 266 sites in United States, Argentina and 22 more
- Volunteers
- 925 people
- Sponsor
- Eli Lilly and Company
Depression, Obesity
Research Aimed at Improving Both Mood and Weight
The RAINBOW study is an NIH R01-funded randomized controlled trial to evaluate the clinical and cost effectiveness and implementation potential of a primary care integrated multicondition intervention program to help improve mood…
- Trial name
- RAINBOW-ENGAGE (NCT02246413)
- Testing
- RAINBOW Intervention Program
- Where
- 2 sites in United States
- Volunteers
- 409 people
- Sponsor
- Palo Alto Medical Foundation
Healthy Volunteers
A Study to Compare the Bioavailability (BA) of Dexlansoprazole Delayed-release Capsules
The purpose of this study is to assess the BA of 30 or 60 milligram (mg) dexlansoprazole capsule manufactured at TOB (Takeda GmbH Plant Oranienburg) to the corresponding 30 or 60 mg dexlansoprazole manufactured at TPC (Takeda…
- Trial name
- NCT03801148
- Testing
- 30 mg dexlansoprazole capsules manufactured at TOB, 30 mg dexlansoprazole capsules manufactured at TPC, 60 mg dexlansoprazole capsules manufactured at TOB
- Where
- United States
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Takeda
Urinary Bladder Neoplasms
A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder
A study to evaluate the safety and tolerability of nivolumab or nivolumab Plus BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer.
- Trial name
- CheckMate 9UT (NCT03519256)
- Testing
- Nivolumab, BCG, BMS-986205
- Where
- 88 sites in United States, Argentina and 13 more
- Volunteers
- 142 people
- Sponsor
- Bristol-Myers Squibb
High-risk Medications
Testing a Medication Risk Communication and Surveillance Strategy: The EMC2 Trial
This study evaluates the effectiveness of an electronic health record based educational intervention (the EMC2 strategy) to improve patient understanding and use of higher-risk medications.
- Trial name
- NCT02785458
- Testing
- EMC2 Strategy
- Where
- United States
- Volunteers
- 1,005 people
- Sponsor
- Northwestern University
Hypertension
Metabolic Effects of Antihypertensive Drugs on People With Metabolic Syndrome (The MEAD Study)
High blood pressure, also referred to as hypertension, is a blood pressure level of 140/90 mm Hg or higher. Along with lifestyle changes, various medications are currently used to treat people with hypertension.
- Trial name
- MEAD (NCT00887510)
- Testing
- Hydrochlorothiazide, Trandolapril
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Florida
Ovarian Cancer, Fallopian Tube Cancer
Japan Phase 2 Study of Niraparib in Participants With Advanced, Relapsed Ovarian Cancer
The purpose of this study is to evaluate the safety and efficacy of niraparib in participants with advanced, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 3 or 4…
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- Trial name
- NCT03759600
- Testing
- Niraparib
- Where
- 33 sites in Japan
- Volunteers
- 20 people
- Sponsor
- Takeda
Hypertension
Text My Hypertension BP Meds NOLA
The specific aims of this research study are to 1. Engage participants with poorly controlled hypertension and medication non-adherence to use simple digital approaches, specifically recurring text-messages to improve medication…
- Trial name
- NCT05074173
- Testing
- Text
- Where
- 2 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Tulane University
Epithelial Ovarian Cancer, Peritoneal Cancer
A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha (FRα) Expression
This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine (MIRV) vs. IC chemotherapy in participants with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or…
- Conditions
- Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- Trial name
- MIRASOL (NCT04209855)
- Testing
- Mirvetuximab Soravtansine, Paclitaxel, Topotecan
- Where
- 214 sites in United States, Australia and 19 more
- Volunteers
- 453 people
- Sponsor
- AbbVie
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
An Efficacy and Safety Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML) and Low-Blast Acute Myelogenous Leukemia (AML)
The purpose of this study is to evaluate the efficacy and safety of pevonedistat plus azacitidine versus single-agent azacitidine in participants with HR-MDS or CMML, or low-blast AML.
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
- Trial name
- NCT02610777
- Testing
- Azacitidine, Pevonedistat
- Where
- 59 sites in United States, Belgium and 10 more
- Volunteers
- 120 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Bleeding Disorder, Ischemic Stroke
XIENCE 28 USA Study
The XIENCE 28 USA Study is prospective, single arm, multi-center, open label, non-randomized trial to evaluate safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR)…
- Conditions
- Bleeding Disorder, Ischemic Stroke, Hemorrhagic Stroke, Hematological Diseases
- Trial name
- NCT03815175
- Testing
- XIENCE, DAPT (aspirin and/or P2Y12 receptor inhibitor)
- Where
- 111 sites in United States, Austria and 13 more
- Volunteers
- 1,605 people
- Sponsor
- Abbott Medical Devices