Clinical trials: High-risk
Hypertriglyceridemia, Cardiovascular Diseases
Study of ISIS 678354 (AKCEA-APOCIII-LRx) in Participants With Hypertriglyceridemia and Established Cardiovascular Disease (CVD)
This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, including tolerability, of ISIS 678354 and to assess the efficacy of different doses and dosing regimens of ISIS…
- Trial name
- NCT03385239
- Testing
- ISIS 678354
- Where
- 31 sites in United States, Canada
- Volunteers
- 114 people
- Sponsor
- Akcea Therapeutics
Colorectal Carcinoma
Study of Pembrolizumab (MK-3475) as Monotherapy in Participants With Previously-Treated Locally Advanced Unresectable or Metastatic Colorectal Cancer (MK-3475-164/KEYNOTE-164)
In this study, participants with previously-treated locally-advanced unresectable or metastatic mismatched repair (MMR) deficient or microsatellite instability-high (MSI-H) colorectal carcinoma (CRC) will be treated with…
- Trial name
- NCT02460198
- Testing
- Pembrolizumab
- Volunteers
- 124 people
- Sponsor
- Merck Sharp & Dohme LLC
Multiple Sclerosis
REbif FLEXible Dosing in Early Multiple Sclerosis (MS)
The study is a 24 months randomized, double-blind, Placebo-controlled, multi-center clinical trial with an optional 12 months open label extension.
- Trial name
- REFLEX (NCT00404352)
- Testing
- RNF
- Where
- 67 sites in Argentina, Australia and 25 more
- Volunteers
- 517 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Hypercholesterolemia
Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112)
A 12 week clinical trial in patients 65 years of age and older with hypercholesterolemia at high risk for coronary heart disease to study the effects of atorvastatin and ezetimibe given in combination and two higher doses of…
- Trial name
- NCT00418834
- Testing
- ezetimibe and atorvastatin, atorvastatin
- Volunteers
- 1,053 people
- Sponsor
- Organon and Co
Carcinoma, Non-Small-Cell Lung
A Study of Intermittent, High-dose Afatinib to Determine the Maximal Tolerated Dose and Assess Activity of This Dose Against Non-small Cell Lung Cancer With T790M Mutations
This trial is divided into Part A and Part B. The primary objective of Part A is to establish the Maximal Tolerated Dose of intermittent high dose afatinib.
- Trial name
- NCT01647711
- Testing
- Dose escalation followed by treatment with MTD
- Where
- 2 sites in United States
- Volunteers
- 35 people
- Sponsor
- Boehringer Ingelheim
Cervical Cancer
Feasibility Study of the Xoft® Axxent® Electronic Brachytherapy System for the Treatment of Cervical Cancer
The purpose of this study is to evaluate the safety, performance and usability of the Xoft Axxent Electronic Brachytherapy System and Cervical Applicator as incorporated into the physician's current standard treatment practice…
- Trial name
- NCT01851772
- Testing
- Treatment with Electronic Brachytherapy
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Xoft, Inc.
Influenza
Study of Fluzone® Influenza Virus Vaccine 2011-2012 Formulation (Intramuscular Route) Among Adults
The aim of the study is to evaluate the safety and immunogenicity of the 2011-2012 formulation of Fluzone and Fluzone High-Dose vaccines in participants aged 65 years and older.
- Trial name
- NCT01430819
- Testing
- Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation, Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation
- Where
- 6 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Follicular Lymphoma, Lymphoma, Follicular
Phase 3 Study of Zevalin Following R-CVP in Previously Untreated Patients With Follicular Non Hodgkin's Lymphoma (NHL)
This study will treat follicular lymphoma patients who have not received previous treatment with R-CVP. Half of the patients will receive Zevalin after R-CVP and the other half will receive only R-CVP.
- Trial name
- NCT00384111
- Testing
- Zevalin Therapeutic Regimen, R-CVP
- Where
- 6 sites in United States
- Volunteers
- 26 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Hypercholesterolemia
A Study to Evaluate the Effects of Ezetimibe (MK-0653) on the Postprandial (Following a Meal) Lipoprotein Response in Participants With Primary Hypercholesterolemia (High Cholesterol) (MK-0653-072)(COMPLETED)
A study to evaluate the cholesterol-lowering effects of ezetimibe in participants with primary hypercholesterolemia (high cholesterol) after eating a meal that is high in cholesterol.
- Trial name
- NCT00101439
- Testing
- ezetimibe
- Volunteers
- 58 people
- Sponsor
- Organon and Co
Hepatocellular Carcinoma
Study of Tivantinib in Subjects With Inoperable Hepatocellular Carcinoma (HCC) Who Have Been Treated With One Prior Therapy
The purpose of this study is to determine if tivantinib (ARQ 197) is effective in treating patients with MET diagnostic-high hepatocellular carcinoma (liver cancer) who have already been treated once with another therapy.
- Trial name
- METIV-HCC (NCT01755767)
- Testing
- Tivantinib
- Where
- 112 sites in United States, Argentina and 14 more
- Volunteers
- 383 people
- Sponsor
- Daiichi Sankyo
Critical Aortic Stenosis
THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial
The purpose of this study is to determine the safety and effectiveness of the device and delivery systems (transfemoral and transapical) in high risk, symptomatic patients with severe aortic stenosis.
- Trial name
- PARTNER (NCT00530894)
- Testing
- Edwards SAPIEN Transcatheter Heart Valve, Surgical Valve Replacement, medical management and/or balloon aortic valvuloplasty
- Where
- 26 sites in United States, Canada and 1 more
- Volunteers
- 1,057 people
- Sponsor
- Edwards Lifesciences
Type 2 Diabetes, High Blood Sugar
Evaluate Efficacy and Safety in Japanese Subjects With Type 2 Diabetes Mellitus
This is a 24-week randomised, multi-centre phase III study to evaluate the efficacy and safety of dapagliflozin as monotherapy in Japanese subjects with Type 2 diabetes mellitus who have inadequate glycemic control with diet and…
- Trial name
- NCT01294423
- Testing
- Dapagliflozin
- Where
- 26 sites in Japan
- Volunteers
- 261 people
- Sponsor
- AstraZeneca
Myelodysplastic Syndromes
A Study of MBG453 in Combination With Hypomethylating Agents in Subjects With IPSS-R Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS).
This Phase II was a multicenter, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to hypomethylating agents (azacitidine or decitabine) in adult subjects with IPSS-R…
- Trial name
- STIMULUS-MDS1 (NCT03946670)
- Testing
- MBG453, Hypomethylating agents
- Where
- 48 sites in United States, Austria and 15 more
- Volunteers
- 127 people
- Sponsor
- Novartis Pharmaceuticals
Presbyopia
A Study to Evaluate the Feasibility of a High Add Multi Focal Contact Lens
The objective of this study is to evaluate the product performance of the investigational multifocal high add soft contact lens compared with PureVision Multi-focal contact lens on a daily wear basis.
- Trial name
- NCT01518868
- Testing
- Investigational contact lens, PureVision contact lens
- Where
- United States
- Volunteers
- 126 people
- Sponsor
- Bausch & Lomb Incorporated
Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome
A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)
The purpose of this study was to evaluate the safety and tolerability and to determine the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD) of ASP7517.
- Trial name
- NCT04079296
- Testing
- ASP7517
- Where
- 16 sites in United States, Japan
- Volunteers
- 43 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Hypertension
An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure
To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood Pressure [msDBP] ≥ 90 mmHg and < 110 mmHg).
- Trial name
- NCT00402103
- Testing
- Aliskiren, Amlodipine, Hydrochlorothiazide
- Where
- 8 sites in United States, Belgium and 6 more
- Volunteers
- 556 people
- Sponsor
- Novartis
Melanoma, Merkel Cell Carcinoma
High-Risk Skin Cancers With Atezolizumab Plus NT-I7
The purpose of this study is to test whether the addition of NT-I7 to atezolizumab provides clinically meaningful outcomes for patients with anti-PD-1/PD-L1 naive or relapsed/refractory high-risk melanoma, Merkel Cell Carcinoma…
- Conditions
- Melanoma, Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma
- Trial name
- NCT03901573
- Testing
- NT-I7, atezolizumab
- Where
- 8 sites in United States
- Volunteers
- 31 people
- Sponsor
- NeoImmuneTech
Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis
A Trial of Fedratinib in Subjects With DIPSS, Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib
This is Single-Arm, Open-Label Efficacy and Safety Trial of Fedratinib in Subjects with DIPSS (Dynamic International Prognostic Scoring System)-Intermediate or High- Risk Primary Myelofibrosis (PMF), Post-Polycythemia Vera…
- Conditions
- Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
- Trial name
- FREEDOM (NCT03755518)
- Testing
- FEDRATINIB
- Where
- 35 sites in United States, Canada
- Volunteers
- 38 people
- Sponsor
- Celgene
Hypercholesterolemia
Evolocumab Compared to LDL-C Apheresis in Patients Receiving LDL-C Apheresis Prior to Study Enrollment
To evaluate the efficacy of subcutaneous (SC) evolocumab, compared to regularly scheduled low-density lipoprotein cholesterol (LDL-C) apheresis, on reducing the need for future apheresis.
- Trial name
- NCT02585895
- Testing
- Evolocumab, Low-density Lipoprotein Cholesterol (LDL-C) Apheresis
- Where
- 17 sites in United States, Australia and 6 more
- Volunteers
- 39 people
- Sponsor
- Amgen
Brain Metastases
An Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis
This is a multicenter, randomized open-label Phase 2 study to assess the safety, efficacy and pharmacokinetic (PK) of 2 dosing regimens of encorafenib + binimetinib combination in patients with BRAFV600-mutant melanoma with brain…
- Trial name
- POLARIS (NCT03911869)
- Testing
- encorafenib, binimetinib
- Where
- 25 sites in United States, Argentina and 3 more
- Volunteers
- 13 people
- Sponsor
- Pfizer