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Kenneth Wu, LLC Page 1 of 3
Contracting and Consulting Projects
Discipline Agent/Device Indication Protocol Phase
Heart Failure
Pacemakers and
Defibrillators
Bradycardia and Cardiac
Arrhythmia
Registration and Post-marketing
Global Clinical Trials
IDE/PMA
Neurologic Combination drug Dementia Bioequivalence studies Phase I
Oncology
Biologic Breast cancer
Dose Ranging and Maximum
Tolerated Dose (MTD)
Phase IIa
Biologic Ovarian Phase IIa
Monoclonal Antibody Lung Phase IIb
Congestive Heart
Failure
Natrecor
(Brain Naturietic
Peptide)
Congestive Heart Failure
(Class IV)
Expand Label to Outpatient
Administration
Phase IIIb
Intravascular
Intervention
Local Delivery of
Beta Radiation
Coronary restenosis
Reduction in coronary restenosis in
stented vessels
Class III PMA
Coronary Stent Coronary occlusions
Coronary stenting with new bare
metal stent design
Class III PMA
Cardiac Surgery
Transmyocardial
Revascularization
(TMR)
Adjunct to Coronary
Bypass Surgery
Percutaneous Approach to
Myocardium Revascularization
(PMR)
Class III PMA
Minimally Invasive
Surgery
Implantable Device
Severe and Morbidly
Obese
Open, Non-randomized, Single
Arm Study
Class III
PMA
Urology Protoporphyrin Prostate Cancer Drug Uptake Study I
Ophthalmology Protoporphyrin
Age Related Macular
Degeneration
Dose Ranging Study II
Oncology Protoporphyrin
Cutaneous Breast
Cancer
Safety and Efficacy Study III
Radiation Oncology
Gadolinium
Texaphyrin
Metastatic Cancer to the
Brain
Safety Study and Dose Ranging
Study
I and II
Radiology
Gadolite; Positive
MRI Contrast Agent
Placebo Control Placebo Comparison Study II
Radiology
Gadolite; Positive
MRI Contrast Agent
Pelvic Pain
Efficacy of Positive MRI Contrast
Agent
III
Kenneth Wu, LLC Page 2 of 3
Contracting and Consulting Projects
Discipline Agent/Device Indication Protocol Phase
Pharmacokinetic
Pharmacology
Angiotensin-Renin II
Receptor Antagonist
Patients with Stable
Hypertension
Dose Ranging Study to Determine
the Optimal Dose
II
Interventional
Radiology
Thrombolytic
Patients with Peripheral
Vascular Occlusions
Efficacy and Safety of Thrombolytic
in Comparison to Surgical
Intervention
III
Emergency Medicine
Biological
Thrombolytic
Patients with Acute
Myocardial Infarcts
Efficacy and Safety of Thrombolytic
for Acute Myocardial Infarct
III
Internal Medicine;
Immunology
Monoclonal Antibody
Patients with Arthritic
Joints
Safety and Efficacy of Monoclonal
Antibody Treatment for
Symptomatic Arthritic Patients
III
Infectious Disease;
Sexually Transmitted
Disease (STD)
Quinolone Antibiotic
Women Tested Positive
with N. Gonorrhea
Efficacy and Safety of Quinalone
in Women with Test Positive for N.
Gonorrhea
III
Allergy and Asthma;
Immunology
Quinolone Antibiotic Chronic Bronchitis
Efficacy and Safety of Drug in
Patients with Bronchitis in
Comparison to Approved Controls
III
Internal Medicine;
Geriatrics
Anti-inflammatory;
Nonsteriodal
Arthritis Symptoms Safety and Efficacy of NSAID III
Psychiatric Antidepressant
Manic Depressive
Patients
Safety and Efficacy of
Antidepressant
III
Pediatrics Vaccine
Whooping Cough
Immunization for
Toddlers
Immunization Study III
Internal Medicine;
Endocrinology
Antiglycolsylation
Agent
Symptomatic and
Asymptomatic Insulin
Dependent Diabetics
Safety and Efficacy of Antidiabetic
Effects of Antiglycolsyation Agent
III
Gynecology and
Obstetrics
Low Molecular
Weight Estrogen
Hormone Replacement
for Postmenopausal
Women
Safety and Efficacy of Low Dose
Estrogen Replacement Therapy
III
Kenneth Wu, LLC Page 3 of 3
Contracting and Consulting Projects
Discipline Agent/Device Indication Protocol Phase
Gynecology and
Obstetrics
Multiphasic
Estrogen/Progestero
ne Birth Control Pill
Birth Control
Comparative Study Against
Approved Drug for Comparison of
Effectiveness
III
Gynecology and
Obstetrics
Combination
Estrogen and
Progesterone Pill
Birth Control
Comparative Study Against
Approved Drug for Comparison of
Effectiveness
III
Internal Medicine
Antiplatelet
Aggregating Factor
(PAF)
Post Acute Stroke
Patients
Efficacy and Safety of Anti- PAF III
Internal Medicine
Calcium Channel
Blocker
Chronic and Stable
Hypertensives
Efficacy and Safety of Third
Generation Calcium Channel
Blocker
II
Internal Medicine
Calcium Channel
Blocker
Chronic and Stable
Hypertensives
Efficacy and Safety of Third
Generation Calcium Channel
Blocker
III

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2016 09 Sep Kenneth Wu Indications

  • 1. Kenneth Wu, LLC Page 1 of 3 Contracting and Consulting Projects Discipline Agent/Device Indication Protocol Phase Heart Failure Pacemakers and Defibrillators Bradycardia and Cardiac Arrhythmia Registration and Post-marketing Global Clinical Trials IDE/PMA Neurologic Combination drug Dementia Bioequivalence studies Phase I Oncology Biologic Breast cancer Dose Ranging and Maximum Tolerated Dose (MTD) Phase IIa Biologic Ovarian Phase IIa Monoclonal Antibody Lung Phase IIb Congestive Heart Failure Natrecor (Brain Naturietic Peptide) Congestive Heart Failure (Class IV) Expand Label to Outpatient Administration Phase IIIb Intravascular Intervention Local Delivery of Beta Radiation Coronary restenosis Reduction in coronary restenosis in stented vessels Class III PMA Coronary Stent Coronary occlusions Coronary stenting with new bare metal stent design Class III PMA Cardiac Surgery Transmyocardial Revascularization (TMR) Adjunct to Coronary Bypass Surgery Percutaneous Approach to Myocardium Revascularization (PMR) Class III PMA Minimally Invasive Surgery Implantable Device Severe and Morbidly Obese Open, Non-randomized, Single Arm Study Class III PMA Urology Protoporphyrin Prostate Cancer Drug Uptake Study I Ophthalmology Protoporphyrin Age Related Macular Degeneration Dose Ranging Study II Oncology Protoporphyrin Cutaneous Breast Cancer Safety and Efficacy Study III Radiation Oncology Gadolinium Texaphyrin Metastatic Cancer to the Brain Safety Study and Dose Ranging Study I and II Radiology Gadolite; Positive MRI Contrast Agent Placebo Control Placebo Comparison Study II Radiology Gadolite; Positive MRI Contrast Agent Pelvic Pain Efficacy of Positive MRI Contrast Agent III
  • 2. Kenneth Wu, LLC Page 2 of 3 Contracting and Consulting Projects Discipline Agent/Device Indication Protocol Phase Pharmacokinetic Pharmacology Angiotensin-Renin II Receptor Antagonist Patients with Stable Hypertension Dose Ranging Study to Determine the Optimal Dose II Interventional Radiology Thrombolytic Patients with Peripheral Vascular Occlusions Efficacy and Safety of Thrombolytic in Comparison to Surgical Intervention III Emergency Medicine Biological Thrombolytic Patients with Acute Myocardial Infarcts Efficacy and Safety of Thrombolytic for Acute Myocardial Infarct III Internal Medicine; Immunology Monoclonal Antibody Patients with Arthritic Joints Safety and Efficacy of Monoclonal Antibody Treatment for Symptomatic Arthritic Patients III Infectious Disease; Sexually Transmitted Disease (STD) Quinolone Antibiotic Women Tested Positive with N. Gonorrhea Efficacy and Safety of Quinalone in Women with Test Positive for N. Gonorrhea III Allergy and Asthma; Immunology Quinolone Antibiotic Chronic Bronchitis Efficacy and Safety of Drug in Patients with Bronchitis in Comparison to Approved Controls III Internal Medicine; Geriatrics Anti-inflammatory; Nonsteriodal Arthritis Symptoms Safety and Efficacy of NSAID III Psychiatric Antidepressant Manic Depressive Patients Safety and Efficacy of Antidepressant III Pediatrics Vaccine Whooping Cough Immunization for Toddlers Immunization Study III Internal Medicine; Endocrinology Antiglycolsylation Agent Symptomatic and Asymptomatic Insulin Dependent Diabetics Safety and Efficacy of Antidiabetic Effects of Antiglycolsyation Agent III Gynecology and Obstetrics Low Molecular Weight Estrogen Hormone Replacement for Postmenopausal Women Safety and Efficacy of Low Dose Estrogen Replacement Therapy III
  • 3. Kenneth Wu, LLC Page 3 of 3 Contracting and Consulting Projects Discipline Agent/Device Indication Protocol Phase Gynecology and Obstetrics Multiphasic Estrogen/Progestero ne Birth Control Pill Birth Control Comparative Study Against Approved Drug for Comparison of Effectiveness III Gynecology and Obstetrics Combination Estrogen and Progesterone Pill Birth Control Comparative Study Against Approved Drug for Comparison of Effectiveness III Internal Medicine Antiplatelet Aggregating Factor (PAF) Post Acute Stroke Patients Efficacy and Safety of Anti- PAF III Internal Medicine Calcium Channel Blocker Chronic and Stable Hypertensives Efficacy and Safety of Third Generation Calcium Channel Blocker II Internal Medicine Calcium Channel Blocker Chronic and Stable Hypertensives Efficacy and Safety of Third Generation Calcium Channel Blocker III