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Cardiovascular

TAK-875_306: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate Cardiovascular Outcomes of TAK-875, 50 mg in Addition to Standard of Care in Subjects with Type 2 Diabetes and with Cardiovascular Disease or Multiple Risk Factors for Cardiovascular Events
The aim of this study is to learn about the cardiovascular safety of TAK-875 (the investigational drug) when given with standard medications for type 2 diabetes in people at risk for cardiovascular disease (CVD). The study doctor is also doing this study to find out if taking TAK-875 plus standard of care diabetic medication is better than taking placebo plus standard of care diabetic medications. TAK-875 is an investigational drug being developed to potentially improve blood sugar control in people with type 2 diabetes. TAK-875 may affect the production of insulin and may improve how the body uses the sugar in your blood.
Website: http://clinicaltrials.gov/show/NCT01609582
Principal Investigator:  James Welker, DO
Research Coordinator:  Barbara Peterson, RN (443) 481-5766

20110118: A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When AMG 145 is Used in Combination With Statin Therapy In Patients with Clinically Evident Cardiovascular Disease
This study is designed to see whether treatment of dyslipidemia with AMG 145 in people who have experienced a prior myocardial infarction or stroke, and who are taking a highly effective dose of a statin, reduces the risk of recurring or additional cardiovascular events
Website:  http://clinicaltrials.gov/ct2/show/NCT01764633?term=20110118&rank=1
Principal Investigator:  James Welker, DO
Research Coordinator:  Susan Cranford, RN  (443) 481-5738

eTRIS – A Randomized, Open-Lablel Parallel-Group, Multi-Center Study for the Evaluation of eTRIS – Efficacy and Safety of Edoxaban Monotherapy Versus (LMW) Heparin/ Warfarin in Subjects with Symptomatic Deep-Vein Thrombosis – edoxaban Thrombus Reduction Imaging Study�
Patients with deep vein thrombosis are often treated with blood thinners such as heparin and warfarin. Patients taking warfarin require frequent blood testing, to make sure they are not taking too much or too little medication and to adjust the dose of warfarin if necessary. Edoxaban is taken by mouth, does not require frequent blood monitoring and is expected to have no significant interaction with foods or most medications. The purpose of this study is to compare edoxaban with warfarin to see if it is safe and effective in the treatment of DVT.
Website:  http://clinicaltrials.gov/ct2/show/NCT01662908?term=eTRIS&rank=1
Principal Investigator:
  James Welker, DO
Research Coordinator:  Barbara Peterson, RN

SAS115359: A Safety and Efficacy Study of Inhaled Fluticasone Propionate/Salmeterol Combination versus Inhaled Fluticasone Propionate in the Treatment of Adolescent and Adult Subjects with Asthma
The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in adolescents and adults (12 years of age and older) taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.
Websitehttp://clinicaltrials.gov/ct2/results?term=SAS115359+SALMETEROL �
Principal Investigator:  James Welker, D.O.
Research Coordinator:  Susan Cranford, RN  (443) 481-5738

LCD-CDAD-10-07: A Randomized, Double-Blinded, Active-Controlled Study of CB-183,315 in Patients with Clostridium difficile Associated Diarrhea
This is a medical research study designed to look at the safety and efficacy of an oral dose of CB 183,315 and oral vancomycin against CDAD (Clostridium difficile Associated Diarrhea).
Websitehttp://clinicaltrials.gov/ct2/show/NCT01598311?term=CDAD+AND+VANCOMYCIN&rank=6
Principal Investigator:  James Welker, D.O.
Research Coordinator:  Barbara Peterson, RN  (443) 481-5766

11-019: Multicenter, Randomized, Active-Controlled Efficacy and Safety Study Comparing Extended Duration Betrixaban With Standard of Care Enoxaparin for the Prevention of Venous Thromboembolism in Acute Medically Ill Patients
The purpose of this study is to find out if a new investigational drug called betrixaban is safe and effective compared to enoxaparin (approved standard of care) to prevent venous thromboembolism (VTE) in hospitalized patients.
Website:  http://clinicaltrials.gov/ct2/show/NCT01583218?term=VTE+11-019&rank=1
Principal Investigator:  James Welker, D.O.
Research Coordinator:  Barbara Peterson, RN (443) 481-5766

SAPPHIRE WW:  Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy
The purpose of this clinical trial is to collect data regarding patients’ medical experiences and conditions following the treatment with certain stenting and distal protection devices in the treatment of obstructive carotid artery disease.  This study is for patients with carotid artery disease.
Website: http://clinicaltrials.gov/ct2/show/NCT00403078?term=CARDIOVASCULAR+SAPPHIRE&rank=6
Principal Investigator: Dr. Jonathan Altschuler – (410)573-6480
Research Coordinator: Candy Costantini, CCRC – (443)481-1343

Elixa (Evaluation of LIXisenatide in Acute coronary syndrome) A randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate cardiovascular outcomes during treatment with lixisenatide in type 2 diabetic patients after an Acute Coronary Syndrome event
The primary objective of this study is to demonstrate that lixisenatide can reduce cardiovascular morbidity and mortality (composite endpoint of cardiovascular (CV) death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina) compared to placebo in type 2 diabetic patients who recently experienced an acute coronary syndrome (ACS) event.
Website:  http://www.clinicaltrials.gov/ct2/show/NCT01147250?term=lixisenatide&recr=Open&rank=1
Principal Investigator:  James Welker, D.O.
Research Coordinator:  Barbara Peterson, R.N., CCRC — 443-481-5766

ALECARDIO:  A Multicenter, Randomized, Double Blinded, Placebo-Controlled Cardiovascular Outcomes study to evaluate the potential of Aleglitazar to reduce Cardiovascular risk in patients with a recent Acute Coronary Syndrome (ACS) event and type 2 Diabetes Mellitus (T2D)
The primary objective of this research study is to determine whether aleglitazar reduces cardiovascular mortality and morbidity (defined as non-fatal myocardial infarction (MI) and non-fatal stroke) in patients with a recent ACS event and T2D
Website:  http://www.clinicaltrials.gov/ct2/show/NCT01042769?term=Aleglitazar&recr=Open&rank=3
Principal Investigator:  James Welker, D.O.
Research Coordinator:  Barbara Peterson, R.N., CCRC – 443-481-5766

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