Clinical trials: High-risk Patients
Diabetes Mellitus, Type 2
CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes
The aim of the study is to investigate the longterm impact on cardiovascular morbidity and mortality, relevant efficacy parameters (e.g., glycaemic parameters) and safety (e.g., weight and hypoglycaemia) of treatment with…
- Trial name
- NCT01243424
- Testing
- linagliptin, glimepiride
- Where
- 613 sites in United States, Argentina and 41 more
- Volunteers
- 6,103 people
- Sponsor
- Boehringer Ingelheim
Pressure Injury
Prevention of Pressure Ulcers in Patients at Medium to High Risk of Developing Pressure Ulcers and Using the DOMUS 4 / AUTO Motorized Air Mattress
The aim of the study is to determine the clinical value of using a powered alternating pressure air mattress (P-APAM) in the prevention of pressure injury (PI) in patients at medium to high risk.
- Trial name
- NCT05472974
- Testing
- Use of a powered alternating pressure air mattress
- Where
- 5 sites in France
- Volunteers
- 86 people
- Sponsor
- Wellell France
Alzheimer Disease, Progressive Supranuclear Palsy
Evaluation of Imaging Characteristics of [18F]PI-2620 PET in AD and PSP Patients Using High and Low Specific Activity
This is an open-label study without randomisation. All eligible patients will receive two administrations of the investigational imaging agent [18F]PI-2620 at a radioactive dose of 185 MBq, one with high specific activity (≤ 5 µg…
- Trial name
- NCT04715750
- Testing
- [18F]-PI2620
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- Life Molecular Imaging GmbH
Elevated Lipoprotein(a)
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS-APO(a)Rx in Participants With High Lipoprotein(a)
The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ISIS-APO(a)Rx given to participants with high lipoprotein(a) for 12 weeks.
- Trial name
- NCT02160899
- Testing
- ISIS-APO(a)Rx
- Where
- 13 sites in Canada, Denmark and 3 more
- Volunteers
- 64 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Advanced Cancer
A Phase I Study of Anlotinib on Pharmacokinetics to Assess the Effect of High Fat Diet in Advanced Cancer Patients
The purpose of this study is to further study the pharmacokinetic characteristics of Anlotinib in Advanced Cancer Patients with High Fat Diet.
- Trial name
- NCT02825563
- Testing
- Anlotinib
- Where
- China
- Volunteers
- 22 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Muscle-Invasive Bladder Carcinoma, Metastatic Urothelial Carcinoma
Modular Trial of sEphB4-HSA in EphrinB2-High Solid Tumors
Patients with solid tumors that have high expression levels of EphrinB2 are treated with regimens that include EphrinB2 inhibitor, sEphB4-HSA.
- Trial name
- NCT06493552
- Testing
- SEphB4-HSA, Pembrolizumab, Gemcitabine
- Where
- United States
- Volunteers
- 700 people
- Sponsor
- Vasgene Therapeutics, Inc
Paroxysmal Atrial Fibrillation
Oral Anticoagulation Therapy Pilot Study
The objective of this study is to determine the safety of discontinuing oral anticoagulation therapy in high risk patients who have had a successful cardiac ablation and remain AF recurrence free for 3 months post ablation.
- Trial name
- OAT (NCT01959425)
- Testing
- Off OAT Group (Test), On OAT Group (Control)
- Volunteers
- 80 people
- Sponsor
- Biosense Webster, Inc.
Chronic Kidney Disease, Diabetic Nephropathy
Evaluate the Efficacy and Safety of Once Daily Administration of Atrasentan Tablets (Low and High) Compared to Placebo in Reducing Residual Albuminuria in Type 2 Diabetic Patients With Nephropathy Who Are Treated With the Maximum Tolerated Labeled Dose of a Renin Angiotensin System (RAS) Inhibitor
Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Study. The objective of the study is to evaluate the efficacy and safety of once daily administration of atrasentan tablets (low dose and high dose) compared…
- Trial name
- RADAR (NCT01356849)
- Testing
- Atrasentan
- Where
- 72 sites in United States, Canada and 2 more
- Volunteers
- 149 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Mitral Regurgitation, Mitral Valve Disease
AHEAD: European Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System
This study will evaluate the safety of the Cardiovalve Transfemoral Mitral Valve System with its associated procedure, and observe the device performance in reducing mitral regurgitation.
- Trial name
- AHEAD (NCT03339115)
- Testing
- Cardiovalve Transfemoral Mitral Valve
- Where
- 11 sites in Germany, Greece and 1 more
- Volunteers
- 30 people
- Sponsor
- Cardiovalve Ltd.
Hypercholesterolemia
Ezetimibe/Simvastatin (10 mg/40 mg) vs. the Doubling of Atorvastatin in High Risk Participants (MK-0653A-134 AM1)(COMPLETED)
Participants currently taking atorvastatin 20 mg will be switched to either atorvastatin 40 mg or ezetimibe/simvastatin 10 mg/40 mg (10/40).
- Trial name
- NCT00782184
- Testing
- ezetimibe/simvastatin 10/40, atorvastatin 40 mg, atorvastatin 20 mg
- Volunteers
- 250 people
- Sponsor
- Organon and Co
High Risk MDS
Phase II Study to Evaluate Overall Response in Patients With Higher Risk Myelodysplastic Syndromes (MDS) Treated With Azacitidine With or Without Deferasirox.
The primary objective of the study is to compare the overall response rate (inclusive of complete response, partial response and hematologic improvement) per IWG 2006 criteria in patients with higher risk MDS treated with…
- Trial name
- NCT02159040
- Testing
- Azacitidine, Azacitidine plus Deferasirox
- Where
- 6 sites in United States
- Volunteers
- 1 people
- Sponsor
- Novartis Pharmaceuticals
Malignant Glioma
Post-Marketing Surveillance of Long-Term Observation of Gliadel Wafer-Investigation of Vital Prognosis in Patients With High Grade Glioma
The objective of this study is to determine the survival status of patients enrolled in study GLI01S (all-case observational study).
- Trial name
- NCT02300506
- Testing
- No intervention
- Where
- 2 sites in Japan
- Volunteers
- 507 people
- Sponsor
- Eisai Co., Ltd.
Essential Thrombocythemia
Anagrelide Retard in Essential Thrombocythemia
The purpose of this study is determine whether Anagrelide Retard is non-inferior to anagrelide immediate release form in treatment of essential thrombocythemia.
- Trial name
- TEAM-ET (NCT02076815)
- Testing
- Anagrelide retard, Thromboreductin
- Where
- 19 sites in Austria, Bulgaria and 3 more
- Volunteers
- 106 people
- Sponsor
- AOP Orphan Pharmaceuticals AG
Hypercholesteremia
Observational to Investigate the Efficacy of CRESTOR 5mg in Reaching LDL-C Target Goals in Patients Who Are at High Risk for a Cardiovascular Event
Observational study to investigate the use and efficacy of CRESTOR 5 mg in reaching LDL-C target goals in both statin naïve and statin treated primary and secondary prevention patients at high risk for a cardiovascular event.
- Trial name
- NCT00347217
- Where
- 215 sites in Netherlands
- Volunteers
- 3,840 people
- Sponsor
- AstraZeneca
Acute Ischemic Stroke
Study to Evaluate The Safety and Efficacy of Balovaptan in Participants With Acute Ischemic Stroke at a High Risk of Developing Malignant Brain Edema
This study is designed to evaluate the safety, efficacy, and pharmacokinetics of balovaptan compared with placebo in participants with acute ischemic stroke (AIS) at risk of developing Malignant Cerebral Edema (MCE)
- Trial name
- NCT05399550
- Testing
- Balovaptan
- Where
- United States
- Sponsor
- Hoffmann-La Roche
Coronary Artery Bypass Graft Surgery, Myocardial Ischemia
A Safety and Efficacy Study to Confirm the Cardioprotective Effects of MC-1 in Patients Undergoing High-Risk CABG
The purpose of this study is to determine the effect of MC-1 on the combined incidence of cardiovascular death and nonfatal myocardial infarction (MI) up to and including 30 days following coronary artery bypass graft (CABG)…
- Conditions
- Coronary Artery Bypass Graft Surgery, Myocardial Ischemia, Reperfusion Injury
- Trial name
- NCT00402506
- Testing
- (MC-1) Pyridoxal 5'-phosphate
- Where
- 2 sites in United States, Canada
- Volunteers
- 3,000 people
- Sponsor
- Medicure
Leukemia, Myeloid, Acute
A Study of Cusatuzumab Plus Azacitidine in Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome Who Are Not Candidates for Intensive Treatment
The purpose of this study is to determine the recommended Phase 2 dose and evaluate safety profile of cusatuzumab in combination with azacitidine in Japanese participants with treatment naïve acute myeloid leukemia (AML) who are…
- Trial name
- NCT04241549
- Testing
- Cusatuzumab, Azacitidine
- Where
- 5 sites in Japan
- Volunteers
- 6 people
- Sponsor
- OncoVerity, Inc.
Hypercholesterolemia, Coronary Heart Disease
Effectiveness and Safety of Ezetimibe Added to Atorvastatin in Patients With High Cholesterol and Coronary Heart Disease (Study P03740)
This is a multicenter, randomized, parallel group, placebo controlled study designed to evaluate the efficacy, safety, and tolerability of ezetimibe added to ongoing atorvastatin therapy compared with ongoing atorvastatin…
- Trial name
- NCT00202904
- Testing
- ezetimibe
- Volunteers
- 81 people
- Sponsor
- Organon and Co
Cardiovascular Diseases, Statin Adverse Reaction
Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo
The purpose of this study is to determine if treatment with bempedoic acid (ETC-1002) versus placebo decreases the risk of cardiovascular events in participants who have or are at high risk for cardiovascular disease and are…
- Trial name
- CLEAR Outcomes (NCT02993406)
- Testing
- Bempedoic acid 180 mg tablet
- Where
- 1,319 sites in United States, Argentina and 30 more
- Volunteers
- 13,970 people
- Sponsor
- Esperion Therapeutics, Inc.
Lymphoma
A Study of MabThera (Rituximab) in Primary Central Nervous System Lymphoma.
This study will evaluate the efficacy and safety of MabThera plus high dose methotrexate plus high dose cytarabine in patients with central nervous system non-Hodgkin's lymphoma.
- Trial name
- NCT00517699
- Testing
- rituximab [MabThera/Rituxan], Methotrexate, Cytarabine
- Where
- 2 sites in Canada
- Volunteers
- 5 people
- Sponsor
- Hoffmann-La Roche