Clinical trials: High-risk Patients
Hematopoietic Neoplasm
Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis
Primary Objective: To evaluate the efficacy of daily oral doses of 400 mg or 500 mg of SAR302503 (Investigational Medicinal Product, IMP) compared to placebo in the reduction of spleen volume as determined by magnetic resonance…
- Trial name
- JAKARTA (NCT01437787)
- Testing
- SAR302503
- Where
- 101 sites in United States, Australia and 23 more
- Volunteers
- 289 people
- Sponsor
- Bristol-Myers Squibb
Post MI Left Ventricular Dysfunction
IdeNtifying High riSk Patients Post Myocardial Infarction With REduced Left Ventricular Function Using External Loop Recorders (INSPIRE-ELR Study)
The purpose of the INSPIRE-ELR study is to characterize arrhythmias in post MI low EF (≤35%) patients in the acute phase (at discharge from hospital after index MI) and chronic phase (at 8-10 weeks after index MI) and to…
- Trial name
- INSPIRE-ELR (NCT01995552)
- Testing
- External Loop Recorder
- Where
- India
- Volunteers
- 250 people
- Sponsor
- Medtronic BRC
Colorectal Cancer
Efficacy and Safety of Tislelizumab (BGB-A317) as Neo-Adjuvant Treatment in Participants With Colorectal Cancer
The main purpose of this study was to help meet the medical needs of people in China with certain types of solid tumors that have specific genetic changes called microsatellite instability-high (MSI-H) or deficient mismatch…
- Trial name
- NCT05116085
- Testing
- Tislelizumab
- Where
- 8 sites in China
- Volunteers
- 33 people
- Sponsor
- BeiGene
Hypercholesterolemia
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).
- Trial name
- NCT01644188
- Testing
- Alirocumab, Ezetimibe, Lipid Modifying Therapy (LMT)
- Where
- 126 sites in United States, Canada and 8 more
- Volunteers
- 720 people
- Sponsor
- Sanofi
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
Metastatic Melanoma
HD IL-2 + Ipilimumab in Patients With Metastatic Melanoma
Phase IV, open-label, randomized, two-arm, multi-center study in patients with metastatic melanoma who are treatment naïve or have previously received a single non-immunologic therapy.
- Trial name
- PROCLIVITY02 (NCT01856023)
- Testing
- High Dose Interleukin-2, Ipilimumab
- Where
- 12 sites in United States
- Volunteers
- 29 people
- Sponsor
- Clinigen, Inc.
Hypertension
A Safety and Tolerability Study of the Combination of Aliskiren/Valsartan in Patients With High Blood Pressure, Followed by Long-term Safety and Tolerability of Aliskiren, Valsartan and Hydrochlorothiazide.
Assessment of the long-term safety and tolerability of the combination of aliskiren and valsartan (300 mg/ 320 mg) in patients with high blood pressure,followed by assessment of long-term safety and tolerability of the…
- Trial name
- NCT00386607
- Testing
- Aliskiren, Valsartan, Hydrochlorothiazide (HCTZ)
- Where
- 4 sites in United States, Canada and 2 more
- Volunteers
- 601 people
- Sponsor
- Novartis
Hypertension
Nifedipine (Adalat CR, BAY A1040) High Dose PK/PD Study
This is a multi-center, randomized, double-blind, 6 x 3 cross-over study. All patients who meet the entry criteria will be required to stop taking any other anti-hypertensive agents than Adalat CR (controlled release), if taken…
- Trial name
- NCT00768560
- Testing
- Nifedipine (Adalat CR, BAYA1040) 80mg OD, Nifedipine (Adalat CR, BAYA1040) 40mg BID, Nifedipine (Adalat CR, BAYA1040) 40mg OD
- Where
- 3 sites in Japan
- Volunteers
- 35 people
- Sponsor
- Bayer
Hypercholesterolemia
Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol
This study will evaluate the lipid-lowering effect and safety of colesevelam therapy administered to heterozygous familial pediatric patients 10 through 17 years of age who are on a stable dose of a pediatric-approved statin…
- Trial name
- NCT00145574
- Testing
- colesevelam HCl
- Where
- 25 sites in United States, Australia and 6 more
- Volunteers
- 194 people
- Sponsor
- Daiichi Sankyo
Pulmonary Fibrosis
Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients
Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid…
- Trial name
- NCT01335464
- Testing
- BIBF 1120
- Where
- 98 sites in United States, Australia and 11 more
- Volunteers
- 515 people
- Sponsor
- Boehringer Ingelheim
Myelodysplastic Syndromes, Myelogenous Leukemia, Acute
A Study of Vismodegib in Patients With Relapsed/Refractory Acute Myelogenous Leukemia and Relapsed Refractory High-Risk Myelodysplastic Syndrome
This study will assess the safety and efficacy of vismodegib in patients with relapsed/refractory acute myelogenous leukemia (AML) and relapsed/refractory high-risk myelodysplastic syndrome (MDS).
- Trial name
- NCT01880437
- Testing
- cytarabine, vismodegib
- Where
- 14 sites in United States, Canada and 1 more
- Volunteers
- 38 people
- Sponsor
- Hoffmann-La Roche
Chronic Obstructive Pulmonary Disease
Assessment of the Safety and Ability of a Once-a-day Dose of an Orally Inhaled Medicine [ie, Glycopyrrolate Inhalation Solution = GIS] to Improve Airflow in the Lungs When Delivered With an Electronic eFlow Nebulizer System in Patients With Chronic Obstructive Pulmonary Disease (COPD)
The study assessed the safety and ability of several doses of an orally inhaled medicine [ie, Glycopyrrolate Inhalation Solution = GIS] to improve airflow in the lungs when delivered with an electronic eFlow nebulizer system in…
- Trial name
- NCT02951312
- Testing
- Glycopyrrolate Inhalation Solution 25mg, Glycopyrrolate Inhalation Solution 75mg, Glycopyrrolate Inhalation Solution 200mg
- Volunteers
- 12 people
- Sponsor
- Sunovion Respiratory Development Inc.
Renal Insufficiency
Renal Safety Evaluation After Dotarem®-Enhanced MRI
Although there is a well documented risk of acute renal failure with the iodinated contrast agents, the implication of intravenous gadolinium-based contrast agents in nephrotoxicity remains controversial.
- Trial name
- RESCUE (NCT00650845)
- Testing
- Dotarem®-enhanced MRI, non-enhanced MRI
- Where
- 15 sites in Belgium, France and 2 more
- Volunteers
- 135 people
- Sponsor
- Guerbet
Dyslipidemias, High Cholesterol
Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.
This study will be a placebo-controlled, double-blind, randomized, phase 3 study to Evaluate the Efficacy, Safety, and Tolerability of Obicetrapib in Participants with a History of Heterozygous Familial Hypercholesterolemia…
- Conditions
- Dyslipidemias, High Cholesterol, Hypercholesterolemia, Familial Hypercholesterolemia
- Trial name
- BROOKLYN (NCT05425745)
- Testing
- Obicetrapib
- Where
- 96 sites in United States, Canada and 8 more
- Volunteers
- 354 people
- Sponsor
- NewAmsterdam Pharma
Ovarian Carcinoma, Breast Cancer
Phase II Study of AZD2281 in Patients With Known BRCA Mutation Status or Recurrent High Grade Ovarian Cancer or Patients With Known BRCA Mutation Status/ Triple Neg Breast Cancer
This is a Phase II, open label, non randomized correlative study of AZD2281 in patients with recurrent breast and ovarian cancer in both BRCA inherited mutation carriers and non-carriers to identify objective response rate and to…
- Trial name
- NCT00679783
- Testing
- AZD2281
- Where
- 6 sites in Canada
- Volunteers
- 99 people
- Sponsor
- AstraZeneca
Essential Hypertension
Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential Hypertension
The purpose of this study is to evaluate the safety and efficacy of fixed combination of valsartan (40 mg and 80 mg) and amlodipine (2.5 mg and 5 mg), valsartan and amlodipine alone, and placebo in reducing blood pressure.
- Trial name
- NCT00425373
- Testing
- Valsartan + amlodipine 40/2.5 mg, Valsartan + amlodipine 40/5 mg, Valsartan + amlodipine 80/2.5 mg
- Where
- Japan
- Volunteers
- 1,474 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer, FGFR 1 High Amplification
A Study of TAS-120 in Patients With Metastatic Breast Cancer
The purpose of the trial is to evaluate a patient's response to a Fibroblast Growth Factor Receptor (FGFR) inhibitor, futibatinib (TAS-120), used either alone or in combination with the hormonal therapy, fulvestrant.
- Conditions
- Metastatic Breast Cancer, FGFR 1 High Amplification, FGFR2 Amplification
- Trial name
- NCT04024436
- Testing
- Futibatinib, Futibatinib plus Fulvestrant
- Where
- 37 sites in United States, Canada and 5 more
- Volunteers
- 64 people
- Sponsor
- Taiho Oncology, Inc.
Symptomatic Severe Aortic Stenosis
FlexNav EU CE Mark Study
The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic…
- Trial name
- NCT03724812
- Testing
- Portico Valve and FlexNav™ Delivery System
- Where
- 6 sites in Denmark, Italy and 2 more
- Volunteers
- 46 people
- Sponsor
- Abbott Medical Devices
Hepatitis C, Chronic
Efficacy and Safety of 24 vs 48 Weeks of Pegetron® (Peginterferon Alfa-2b + Ribavirin) in Naïve Genotype 1 Hepatitis C (Study P05016)(TERMINATED)
This is a Phase IIIB randomized, controlled, multi-centre, open-label study of 24 versus 48 weeks therapy with Pegetron® (peginterferon alfa-2b + ribavirin) at standard doses in naïve Hepatitis C Virus (HCV) genotype 1 high viral…
- Trial name
- NCT00423800
- Testing
- Combination of pegylated interferon alfa-2b (PEG) and ribavirin (RBV)
- Volunteers
- 56 people
- Sponsor
- Merck Sharp & Dohme LLC
Dyslipidemia, Hypercholesterolemia
A Study to Evaluate Fasting/Postprandial Serum Apolipoprotein B-48 (ApoB-48) Levels in Diabetic Participants With Normal to Moderately High Low Density Lipoprotein-C (LDL-C) Levels (MK-0653A-259 AM1)
This study will evaluate whether fasting/postprandial serum ApoB-48 levels are increased in diabetic participants compared to nondiabetic participants with the same range of serum LDL-C levels, and whether ApoB-48 levels can be…
- Trial name
- NCT01333436
- Testing
- Test Meal
- Where
- South Korea
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- Organon and Co