Most recent CV Version

1. Mary Koppe-Dixon, RN
Senior Clinical Research Associate
Meredith King Clinical Research Consulting
12665 NW 126th
Court
Platte City, MO 816-739-2624
SUMMARY OF EXPERIENCE
Phase I – IV Experience in Monitoring the following: Adult /Pediatric Asthma and Allergy (Including device
delivery systems), Cardiology, Cardiac and Carotid Stents, Cardiac Device, Orthopedic Device,
Hypertension, Dyslipidemia, Dermatology, Tinea Pedis, Tinea Cruis, Vaginal Candidiasis, Bacterial
Vaginosis, Skin Infections, Hepatitis B, Renal Dialysis, Urology/Renal Disease, Oncology (Phase 1),
Parkinson’s Disease, Multiple Sclerosis, Alzheimer’s, Dementia, Lupus, Rheumatoid Arthritis, Epilepsy,
Diabetes, Migraine, Stroke, Depression, Schizophrenia, Insomnia, GERD, Ulcerative Colitis, H-pylori,
Chronic Constipation, Crohn’s Disease, Pediatric/Adult Ophthalmology (Infection, Macular Edema,
Glaucoma, AMD, Retinal Disease, Allergic Conjunctivitis), and Infant Nutrition. I have worked with Inform,
Phoenix Data Systems, Impact, MediData/Rave, Oracle, eClinicalOs, and other EDC systems. I am
proficient in CTMS, Microsoft Word, Excel, and Power Point software.
EDUCATION Oak Park Senior High School, Kansas City, MO
Research College of Nursing, Kansas City, MO
UMKC Bloch School of Business, Kansas City, MO
LICENSES Registered Nurse in State of Missouri 087891
SUMMARY OF POSITIONS
Alcresta Pharmaceuticals September 2015 to Present
Hospira September to December 2015
NCGS December 2013 to June 2015
Pfizer January 2014 to October 2014
Rockwell Medical May 2013 to December 2013
MMG August 2013 to December 2013
WCT SR CRA June 2012 to June 2013
Contract SR CRA Covance Inc. March 2012 to June 2012
Contract CRA PRA July 2011 to March 2012
Page 1 of 16

2. Contract /Lead CRA Ingenix //SuperGen/Regeneron October 2009 – March 2012
Contract CRA, DCRI August 2007- July 2011
Contract CRA, Novo Nordisk December 2007 - June 2008
Contract Lead CRA Pharmasset June 2008 - September 2008
Senior CRA, PAREXEL, Cary, NC April 2005 - August 2007
CRA ICON/BPA, CIN August 2001 – April 2005
Project Leader/ SR CRA, Bailer Research, Overland Park, KS May 1999 - August 2001
Summary of Duties:
Responsibilities included: Total site management and monitoring of Phase 1 - IV drug and device
protocols. Assisted and trained research site staff to ensure the quality and integrity of data, as well as
compliance with GCPs. Assisted in protocol development, creation of monitoring report templates, CRF
completion guidelines, data correction forms, electronic case report forms, and the development of
enrollment/tracking/retention reports. Interacted with PIs, Sub-Is, Site Staff, Vendors, Sponsor and CRO
personnel to carry out these tasks. Performed qualification, initiation, monitoring, termination and CRA
assessment site visits as needed. Trained, mentored, and supervised other less experienced CRAs. Was
the Project Leader on four bioequivalence Tinea protocols. Supervised 6 employees. Functioned as a
Clinical Lead on 4 other trials for CNS, and Parkinson Trials.
Clinical Site Director SMO, PC3, Kansas City, MO October 1998 – April 1999
Clinical director was responsible for the start-up of a new expansion office for site management
organization (SMO). Duties included: physician recruitment and contracting, networking with
local CRA and CRO contacts for study leads, supervision, recruitment, training and hiring of
study coordinators and administrative support staff, negotiation of new office lease, new office
set-up, formulating study budgets, management of office budget, physician and patient
payments, staff payroll and overall Study Management.
Clinical Site Manager SMO, Novum, Kansas City, MO August 1997 – October 1998
Clinical Manager was responsible for the start-up of a new expansion office for site
management organization (SMO) Duties included: physician recruitment and contracting,
networking with local CRA and CRO contacts for study leads, supervision, recruitment, training
and hiring of study coordinators, negotiation of new office lease, new office set-up, formulating
study budgets, management of office budget, physician and patient payments, staff payroll and
overall Study Management.
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3. International Medical Technical Associates, Inc., (IMTCI, now PRA International) Lenexa,
KS July 1990 to August 1997
Clinical Research Associate, June 1993-Aug 1997
Conduct site inspections for clinical research studies; review case report forms (CRF) and tag
for corrections; inventory drug supplies; compile monitoring and progress reports to assure
quality assurance; communicate with investigators to maintain study cohesion. Functioned as
Lead CRA on two trials, and also assisted in the on and off site training of new CRAs.
Quality Assurance Clinical Associate, Department of Regulatory Affairs, June 1992-June 1993
Responsible for regulatory audits; quality assurance monitoring of in-house and management
studies; assist in development and review of new and existing SOPs and IOPs; function as
OSHA compliance officer; conduct staff in-service training.
Study Coordinator/Manager July 1990-June 1992
Involved in analysis and conduct of in-house Phase 1-IV studies; including staff supervision of a
team of 8 -10, developed study progress notes and tracked study status on weekly
basis. Performed study related procedures as required. Manager of unit from Jan 1991 to June
1992
Nurse Consultant, MediClaim/Medical Supply Network, Beaverton OR, July 1989 -May
1990
As a Nurse Consultant conducted in-service education to Long Term Care staff in areas of
wound and decubitus care, urinary catheter and ostomy care, enteral feeding and nutrition. I
assisted with proper coding and handling of Medicare A and B patient invoices. I identified
patients for reimbursement qualifications by conducting chart audits to assure proper ICD 9
diagnosis codes and proper caloric calculations for enteral feeding requirements. I developed
and performed in-service education for applicable products and services. I identified and
developed relationships with local medical supply companies for facilities benefit.
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4. ALLERGY AND ASTHMA RESEARCH STUDIES
The Efficacy of Theophylline in Decreasing the Use of Inhaled Beta 2-Agonists in
Stable, Mild to Moderate Asthma Patients
Safety and Efficacy of AA-2414 in Patients with Moderate Asthma
The Safety and Pharmacokinetics of Single Oral Doses of ICI 204,219 in Adolescent
Male Asthmatics.
A Randomized, Double Blind, Parallel-Group, Clinical Trial of the Effects of Twelve-
Month Courses of an Investigational Beta-Adrenergic Agonist versus Placebo on
Methacholine-Induced Bronchial Hyper-Responsiveness in Adolescent and Adult
Patients with Chronic Mild-to-Moderate Asthma
A Double Blind, Randomized, Placebo-Controlled, Single-Dose Crossover Study of The
Broncho-protective Effect of Albuterol Sulfate Dry Powder Inhaler and Albuterol
Metered-Dose Inhaler (Lead CRA)
Dose Comparison Crossover Study of HFA-134a Salbutamol Sulfate, HFA-134a
Salbutamol Sulfate Placebo Formulation and Ventolin in Patients with Reversible
Obstructive Airway Disease
Dose Comparison Crossover Study of HFA-134a Salbutamol Sulfate, Ventolin, and
Placebo in Patients with Reversible Obstructive Airway Disease
Randomized Double Blind Study of Inhibition of Histamine Skin Wheal Reactions by
Single, Oral Doses of KW4679
A Comparison of the Effect of Acrivastine, Terfenadine and Diphenhydramine Upon
Electrocardiograph Intervals and Cardiac Rhythm in Healthy Male Volunteers.
Multiple Dose Safety and Pharmacokinetics Study of Inhaled ICI 204,219 in Male
Asthmatics
A Double Blind, Randomized Study Comparing the Efficacy and Safety of a Long-Acting
Antihistamine and Placebo in Black Patients with Seasonal Allergic Rhinitis
A Study of Three Dose Levels of Once-A-Day Corticosteroid Nebulizing Suspension
and Placebo in Asthmatic Children Aged Eight Years and Younger
Page 4 of 16

5. DEVICE TRIALS AND OTHER IVDs
Pfizer Consumer Healthcare Protocol B3551003: “Evaluation of the Effect of
Benzonatate on QT Intervals Following Single Dose Administration on Benzonatate to
Healthy Volunteers
Study to Evaluate Safety, Tolerability and Fat Absorption Using a Novel Enteral Feeding
In-line Digestive Enzyme Cartridge RELIZORB™ in Patients with Cystic Fibrosis
Receiving Enteral Tube Feeding
Two-Way Comparison of Hypertension Control Involving Calcium Channel Blockers
found in Hospital Formulary for Cost Reduction Analysis at the VAMC.
A Randomized Multi-Center Trial to Evaluate the Safety and Efficacy of the Cervical (IF)
Cage for Cervical Fusion
Acute MI with Stent and PCTA versus PCTA and Standard of Care
*Four Cardiac Studies involving Evaluation of new Cardiac Stents for FDA approval
*Three Studies involving Cardiac Embolectomy Devices for FDA approval
Cadillac Controlled Abciximab & Device Investigation to Lower Late Angioplasty
Complications
SAPPHIRE (Stenting and Angioplasty with Protection in Patients at High Risk for
Endarterectomy)
*Two studies involving new Carotid Artery stents versus standard of care medication for
FDA approval
A Randomized Multi-Center Trial to Evaluate the Safety and Efficacy of the Cervical (IF)
Cage for Cervical Fusion
Pan Registry Study involving Medtronic Post Marketing approval devices
Medtronic Adapt Response Study Comparing Cardiac Resynchronization Therapy
(CRT) device AdaptivCRT® (aCRT) algorithm against standard CRT devices in CRT
indicated patients with normal atrio-ventricular (AV) conduction and left bundle branch
block (LBBB).
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6. PSYCHIATRY EPILEPSY INSOMNIA RESEARCH STUDIES
A comparison of Zolpidem Tartrate Extended-Release vs. Placebo in the Treatment of
Insomnia Associated with Generalized Anxiety Disorder (GAD) when Used
Concomitantly with Escitalopram (Lexapro
A Multicenter, Randomized, Double blind Placebo Controlled study of the efficacy and
Tolerability of Indiplon therapy Initiated with Sertraline versus Sertraline monotherapy in
Patients with Insomnia and Major Depressive Disorder.
A 2-Year, Prospective, Blinded-Rater, Open-Label, Active-Controlled, Multicenter,
Randomized Study of Long-Term Efficacy and Effectiveness Comparing Risperdal®
Consta® and Abilify® (Aripiprazole) in Adults With Schizophrenia
A Multicenter, Open-Label, Pilot Study of Lamotrigine as Adjunctive Therapy and
Monotherapy Patients with Epilepsy and Co morbid Depressive Symptoms.
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the
Efficacy and Safety of Once a Day, TAK-375 Tablet for Sublingual Administration (TAK-
375SL Tablet) 0.1, 0.4, and 0.8 mg in the Treatment of Acute Depressive Episodes
Associated with Bipolar 1 Disorder in Adult Subjects who are on Lithium or Valproate
A Randomized, Double Blind, Placebo-Controlled, Proof-of-Concept, Phase 2 Study to
Evaluate the Efficacy and Safety of Once a Day, TAK-375SL 0.1, 0.4, and 0.8 mg as an
Adjunctive Therapy to Treatment-as-Usual in the Maintenance Treatment of Bipolar I
Disorder in Adults and Teens
A Randomized, Single-Blind, Multi-Center Study to assess the Safety and Efficacy of
Medication X in the Treatment of patients with Epilepsy and Depression
Anti-Brain Antibodies in Epilepsy in diagnosed patients under current treatment
A 2 Year, prospective, blinded rater, open label active controlled multi-center
randomized study of long-term efficacy and effectiveness of Risperdal Consta and
Abilify in adults with Schizophrenia.
Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia: a 12-
Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study LTE 6217
(Sanofi-Aventis)
Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia
Followed by Optional Extension up to 1 Year (Sanofi-Aventis)
Page 6 of 16

7. MIGRAINE CNS AUTOIMMUNE DISEASE RESEARCH STUDIES
An Open Label Study of the Safety and Efficacy of Combination Therapy with
AVONEX® and Bi-Monthly High Dose Intravenous Methotrexate with Leucovorin
Rescue in Multiple Sclerosis
A Phase I Multiple dose Study of the Safety and Tolerability of REGN88 in Rheumatoid
Arthritis Subjects (Regeneron)
A Phase 3, Multicenter, Double-blind, Placebo-controlled Randomized Discontinuation
Study Followed by an Open-label Extension Period to E valuate the Efficacy and Safety
of Amifampridine Phosphate (3,4-Diaminopyridine Phosphate) in Patients with Lambert-
Eaton Myasthenic Syndrome (LEMS)
A Phase III Multicenter, Double Blind, Placebo-controlled, Parallel Group 52-week Study
to Assess the Efficacy and Safety of 2 Dose Regimens of CDP870 as Additional
Medication to Methotrexate in the Treatment of Signs and Symptoms and Preventing
Structural Damage in Patients With Active RA Who Have an Incomplete Response to
Methotrexate
A Phase II, Randomized, Double-Blind, Placebo Controlled Study to evaluate the
Preliminary Efficacy, Pharmacokinetics and Immunogenicity of An Experimental
Medication Administered to Subjects with Relapsing-Remitting Multiple Sclerosis.
A Randomized, Single-Blind, Multi-Center Study to assess the Safety and Efficacy of
Medication in the treatment of Early Senile Dementia
A Phase II Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Study Of PF-
04447943 In Subjects With Mild To Moderate Alzheimer’s Disease
A 26-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate
the Effects of Daily Administration of AC-1204 in Participants with Mild to Moderate Alzheimer's
Disease (AD) with an Optional 26-Week Open-label Extension (Accera)
A Phase III, Double-Blind, Placebo-Controlled, Multinational Study of the Efficacy,
Safety and Tolerability of Sumanirole and Ropinirole vs. Placebo in Patients with early
Parkinson’s disease.
A Randomized, Placebo-Controlled, Three Treatment Arm Study to Determine the
Safety and Efficacy of an Anti-coagulant Injection in Patients with Acute Ischemic
Stroke.
A 26-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to
Investigate the Effects of Daily Administration of AC-1204 in Participants with Mild to
Moderate Alzheimer's Disease (AD) with an Optional 26-Week Open-label Extension
Page 7 of 16

8. MIGRAINE CNS AUTOIMMUNE DISEASE RESEARCH STUDIES
Self-Administered Sumatriptan Injections Placebo in the Acute Treatment of a Single
Early-Morning Migraine Attack
A Multicenter, Randomized, Open-label Comparison of the Effects of ZOMIG-ZMT(R)
(zolitriptan) and Unusual Migraine Care on Work Loss and Productivity and Patient
Preference.
A Randomized, Single Blind, Multi-Center Study to assess the Safety of the Long-Term
Administration of NBI-34060 in Patients with Primary Insomnia
SN-SIAL-301: A Phase 3, Multicenter, Double-Blind, Placebo-Controlled, Single-
Treatment Efficacy and Safety Study of MYOBLOC®
(Part A) Followed by Open-Label,
Multiple-Treatment with MYOBLOC®
(Part B) in the Treatment of Troublesome
Sialorrhea in Adult Subjects
Labrys Biologics LBR-101-022 A Multicenter, Randomized, Double-Blind, Placebo-
Controlled, Parallel-Group, Study Comparing the Efficacy and Safety of Two Doses of
Subcutaneous LBR-101 with Placebo for the Preventive Treatment of High Frequency
Episodic Migraine
Labrys Biologics LBR-101-021 - A Multicenter, Randomized, Double-Blind, Double-
Dummy, Placebo- Controlled, Parallel Group, Multi-dose Study Comparing the Efficacy
and Safety of Subcutaneous LBR-101 with Placebo for the Preventative Treatment of
Chronic Migraine
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9. MISC RESEARCH STUDIES (PAIN ONCOLOGY VACCINES)
An Open-label, Multicenter Study of the Safety of Twice Daily Oxycodone Hydrochloride
Controlled-release Tablets in Opioid Experienced Children from Ages 6 to 16 Years Old,
Inclusive, with Moderate to Severe Malignant and/or Nonmalignant Pain Requiring
Opioid Analgesics
SGI-0470-06: Phase 1 Safety and Pharmacokinetics of Repeated Doses of Oral MP-
470 (Amuvatini) Lipid Suspension Formulation in Healthy Male Subjects (Tyrosine
Kinase Inhibitor)
SGI-0470-06 A Phase 1b 100-patient, 5-arm Phase 1b trial Oral MP-470 (Amuvatini)
Lipid Suspension Formulation
A Phase 1 Randomized, double-blind, placebo-controlled, single ascending dose study
to assess the safety and tolerability of Intravenous (IV) and Subcutaneous (SC)
REGN1033 (SAR391786) in healthy volunteers.
A Randomized Trial to Evaluate the Safety and Efficacy of LHRH agonist in conjunction
with or in addition to Conventional Therapy (either Tamoxifen or chemotherapy or both)
versus in the Treatment of Breast Cancer in Premenopausal Women (never enrolled)
A Multi-Center Trial of Use of Tamoxifen versus a New Medication in the Treatment of
Stage III Breast Cancer in Post-Menopausal Women with estrogen receptor positive
cancer (never enrolled)
An Open Label Study to Assess the Safety and Tolerability of BEMA® Buprenorphine
NX in Opioid Dependent Subjects in Mucosal Film Format
H1N1 002 (113480) A study to evaluate the safety, immunogenicity, and relative
efficacy of A/California/7/2009 (H1N1) v-like vaccines GSK2340274A and
GSK2340273A in adults aged 18 years and older
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10. OPTHAMALOGY
A Phase I, Open Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and
Pharmacokinetics of iCo-007 Intravitreal Injection in Subjects with Diffuse Diabetic
Macular Edema
A Multi Center Double Masked Phase II study to evaluate the clinical and microbial
efficacy a new compound compared to conventional treatment in the treatment of
bacterial conjunctivitis in children and adults
A Multi Center Placebo Controlled Double-Masked Phase III Study of the Effects on
Visual Loss in Patients with Non Proliferative Diabetic Retinopathy
A Randomized, Double-Masked, parallel Group Comparison of Xalacom™ Given In The
Evening, Xalatan® Given In The Evening, and Timolol™ Given In The Morning In
Subjects With Open Angle Glaucoma or Ocular Hypertension
A Phase 2, Multi-center, Randomized, Controlled, Masked Study of the Effects of
Squalamine Lactate in Combination with Visudyne in Patients with Subfoveal Choriodal
Neovascularization Associated with Age-Related Macular Degeneration
A Phase 2, Multi-center, Randomized, Masked, Controlled, (Squalamine Lactate) for the
treatment of Subfoveal Choroidal Neovascularization Associated with Age-Related
Macular Degeneration
A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Ocular Safety
of a drug in Subjects participating in the SPRI PO4737 Study (DCRI)
A Phase I Double Blind, Placebo Controlled Study to Evaluate the Ocular Safety of a
drug in Health Subjects or Subjects with Atherosclerotic Disease (DCRI)
Page 10 of 16

11. DEVICE TRIALS AND OTHER IVDs
Pfizer Consumer Healthcare Protocol B3551003: “Evaluation of the Effect of
Benzonatate on QT Intervals Following Single Dose Administration on Benzonatate to
Healthy Volunteers
Study to Evaluate Safety, Tolerability and Fat Absorption Using a Novel Enteral Feeding
In-line Digestive Enzyme Cartridge RELIZORB™ in Patients with Cystic Fibrosis
Receiving Enteral Tube Feeding
Two-Way Comparison of Hypertension Control Involving Calcium Channel Blockers
found in Hospital Formulary for Cost Reduction Analysis at the VAMC.
A Randomized Multi-Center Trial to Evaluate the Safety and Efficacy of the Cervical (IF)
Cage for Cervical Fusion
Acute MI with Stent and PCTA versus PCTA and Standard of Care
*Four Cardiac Studies involving Evaluation of new Cardiac Stents for FDA approval
*Three Studies involving Cardiac Embolectomy Devices for FDA approval
Cadillac Controlled Abciximab & Device Investigation to Lower Late Angioplasty
Complications
SAPPHIRE (Stenting and Angioplasty with Protection in Patients at High Risk for
Endarterectomy)
*Two studies involving Carotid Artery stents versus standard of care medication for FDA
approval
A Randomized Multi-Center Trial to Evaluate the Safety and Efficacy of the Cervical (IF)
Cage for Cervical Fusion
Page 11 of 16

12. INFECTIOUS DISEASE, ANTI FUNGALS ANTI MICROBIALS AND DERMATOLOGY
A Phase III, Randomized, Double-Blind, Multi-Center Study to Evaluate the Safety and
Efficacy of Dalbavancin versus Cefazolin in the Treatment of Uncomplicated Skin and
Soft Tissue Infections with Suspected or Confirmed Gram-Positive Bacterial Pathogens
A Phase III, Randomized, Double-Blind, Multi-Center Study to Evaluate the Safety and
Efficacy of Dalbavancin versus Linezolid in the Treatment of Complicated Skin and Soft
Tissue Infections with Suspected or Confirmed Gram-Positive Bacterial Pathogens
A Multi-Center, Prospective, Randomized, Double blind, Parallel Group Comparison of
a 3-Day Treatment Regimen with a 7-Day Treatment Regimen for the Treatment of
Candidiasis
A Three-Way, Randomized Study of an Antibacterial and a New Medication for the
Treatment of Duodenal Ulcers Caused by H-pylori in the Adult Population.
*Four Studies involving Equivalence of a generic versus name brand Anti-Fungal
Medication used for the treatment of Tinea Pedis run by Altana Pharmaceuticals
(Project Manager for 2 of 4)
*A Study involving the dosing Equivalence of a generic versus name brand Anti-
Bacterial Medication used for the treatment of Bacterial Vaginosis run by Altana
Pharmaceuticals (Project Manager)
A Study involving the dosing Equivalence of a generic versus a name brand of Topical
Antibacterial Medication used for the treatment of Adult Rosacea run by Altana
Pharmaceuticals
A Study involving the dosing Equivalence of a generic versus a name brand of Topical
Antibacterial Medication used for the treatment of Acne Vulgaris in teens and adults run
by Altana Pharmaceuticals
Efficacy, Safety and Tolerability of Topical 10% Terbinafine Versus 5% Amorolfine Nail
Lacquer in Patients With Mild to Moderate Toenail Onychomycosis Novartis
A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of
REGN668 Administered Subcutaneously by two methods to Healthy Volunteers (atopic
dermatitis)
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13. GI, ENDOCRINE AND HEPATITIS
A Multi-center, Randomized, Double-Blind, Active-Control, 96 Week, Phase III Trial of
the Efficacy and Safety of Clevudine Compared with Adefovir at Weeks 48 and 96 in
Nucleoside Treatment-Naïve Patients with HBeAg Positive Chronic Hepatitis due to
Hepatitis B Virus (Pharmasset)
Three Protocols for a Three-Way, Randomized Study of an Antibacterial and a New
Medication for the Treatment of Duodenal Ulcers Caused by H-pylori in the Adult
Population. Bristol Myers Squibb
A 13-week Multinational, Randomized, Double-Blind, Placebo-Controlled, Dose-
Response Trial Assessing the Safety, Tolerability and Efficacy of AVE0010 in
Metformin-Treated Subjects With Type 2 Diabetes Mellitus
A Twelve-week, Randomized, Double-Blind, Placebo-Controlled Study to Assess the
Safety and Efficacy of 0.5 mg QD, 1mg QD and 1 mg BID of Alosetron in Female
Subjects with Severe Diarrhea Predominant Irritable Bowel Syndrome who Have Failed
Conventional Therapy
Efficacy of Tegasarod in Relieving the Symptoms of Female Patients With Irritable
Bowel Syndrome (IBS), Excluding Those With Predominant Diarrhea IBS
Safety and Efficacy of Exubera Compared with subcutaneous Human Insulin therapy in
children with Type 1 Diabetes Mellitus (DCRI)
A Phase II Randomized Double-Blind Placebo-Controlled Pharmacodynamics
Evaluation of ONO-5129 in Patients With Treatment Naive Type 2 Diabetes Mellitus
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14. RENAL RESEARCH STUDIES
A PHASE 3b Investigation of Erythropoietin Drugs Using a Specified Dosing Algorithm:
A Randomized Open Label Dosing Study in Adult Chronic Kidney Disease Subjects on
Hemodialysis
A Therapeutic-Equivalence Study Comparing the Efficacy and Safety of Intravenous
Epoetin (Hospira) and Epoetin alfa (Amgen) in Patients with Chronic Renal Failure
Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment
A Randomized, Placebo-Controlled, Phase III Study of Dialysate Containing Soluble
Ferric Pyrophosphate (SFP) in Chronic Kidney Disease Patients Receiving
Hemodialysis: The Continuous Replacement Using Iron Soluble Equivalents
(CRUISE 2) Study
An Open-Label, Single-Dose, Pharmacokinetic Study of 10 mg of an Antihistamine in
Volunteers with Various Degrees of Renal Insufficiency.
A Randomized, Placebo-Controlled, Phase III Study of Dialysate Containing Soluble
Ferric Pyrophosphate (SFP) in Chronic Kidney Disease Patients Receiving
Hemodialysis: The Continuous Replacement Using Iron Soluble Equivalents
(CRUISE 1) Study
A Phase 3 Multi-centered Double Blind Placebo Controlled Parallel Arm Trial to
Determine Long term safety and Efficacy of Oral Medication in Patients with Autosomal
Dominant Polycystic Kidney Disease
Outcome Trial Evaluating the Efficacy and Safety of Norditropin in Adult Patients on
Hemodialysis with ESRD (Novo Nordisk)
AbbVie M11-352 SONAR A Randomized, Multicounty, Multicenter, Double Blind,
Parallel, Placebo-Controlled Study of the Effects of Atrasentan on Renal Outcomes in
Subjects with Type 2 Diabetes and Nephropathy SONAR: Study of Diabetic
Nephropathy with Atrasentan
A 52-Week Trial Involving an Anti-D-hydrotestorerone Compound versus Placebo in
Males with Moderate BPH Symptoms.
Evaluation of Treatment Satisfaction of 25, 50 and 100 mg of Tablet Preparation Used
for Male Subjects with Impotence.
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15. PHASE 1 RESEARCH STUDIES
A Phase 1 Study to Evaluate Carry-Over Effect and Intra-Subject Variability of Drug
Dosage Forms and Pharmacokinetics in Subjects with Renal Impairment.
Protocol SGI-0470-06: Phase 1 Safety and Pharmacokinetics of Repeated Doses of
Oral MP-470 Lipid Suspension Formulation in Healthy Male Subjects (SuperGen)
A Placebo-Controlled, Double Blind, Multiple-Dose, Study of the Effect of RP-59227 on
Hypothalamic-Pituitary-Adrenal (HPA) and Renal Function in Man.
An Open-Label, Randomized, Parallel-Group, Single Dose Study to Assess the Effect of
Injection Rate on Safety, Tolerability, Pharmacokinetics, and Immunogenicity of
REGN668 Administered to Healthy Volunteers
A Phase 1, Multiple-Dose Study of the Safety and Tolerability of Single Agent REGN421
Administered Every 2 or 3 Weeks in Patients With Advanced Solid Malignancies
Exercise Feasibility Trial for the Evaluation of Delayed Onset Muscle Soreness as a
Result of Eccentric Exercise on the Biodex.
A Randomized, Double Blind, Placebo-Controlled, Single, Ascending Dose Study of the
Safety, Tolerability, Pharmacokinetics, and Bioeffect of Intravenously or
Subcutaneously Administered REGN1033 in Healthy Young and Elderly Volunteers
A Double Blind, Placebo-Controlled, Randomized Comparison of an Effervescent
Dosage Form with a Solid Dosage Form in the Treatment of Congestion and Other
Subjective Complaints of the Common Cold in pediatric and adult subjects
Comparison of NSAID Absorption and Elimination Kinetics Following the Oral
Administration of a Single-Dose Administered as a 25 mg Capsule, Two 12.5 mg Direct
Compression Tablets, or Two 12.5 mg Wet Granulation Tablets.
Bioavailability and Dose Proportionality of 50, 75, and 100 mg of a Medication
Administered Twice Daily for 7 Days.
Exercise Feasibility Trial for the Evaluation of Delayed Onset Muscle Soreness Utilizing
the Biodex at 50% and 75% maximum Strength.
Evaluation of the Sensitivity of Delayed Onset Muscle Soreness to Nonsteroidal Anti-
Inflammatory Drug Treatment (Ibuprofen) or Placebo.
Pharmacokinetics of Phenylephrine Following Oral Dosing.
A Pharmacokinetics Study of Diphenhydramine and Phenylpropanolamine in
Effervescent and Non-Effervescent Night Time Combination Cold Formulations.
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16. PHASE 1 RESEARCH STUDIES
The Steady-State Pharmacokinetics and Bioavailability of a Controlled Release Entex
PSE Tablet Relative to Corresponding Immediate Release Liquids in Humans.
A Three-Way Crossover Comparison of Ketoprofen Bioavailability Following the Oral
Administration of a Single Dose
Comparison of Study Medication Absorption and Elimination Kinetics Following the Oral
Administration of a Single Dose Administered as a 100 mg Dose in Solution or a 100
mg Dose as a Tablet.
Multiple-Dose, Randomized, Open-Label, Two-Way Complete Crossover, Single-Center
Comparison of the Pharmacokinetics of Pseudoephedrine Hydrochloride Following Oral
Ingestion
Administration of Alka-Seltzer Plus Flu Medicine or Night Time Theraflu Maximum
Strength Flu Cold and Cough Medicine to Normal Healthy Volunteers.
The Human Bioequivalence Study of an Entex PSE Tablet Manufactured at Eaton
Laboratories, Puerto Rico Relative to Entex PSE Manufactured at the North Norwich
Facility.
An Open-Label, Single-Dose, Pharmacokinetic Study of 10 mg of an Antihistamine in
Volunteers with Various Degrees of Renal Insufficiency.
Double Blind, Clinical Efficacy Study Comparing Two Inhalations of Pirbuterol versus
Placebo in a Breath-Actuated Aerosol Inhaler in adult and pediatric population.
A Rising, Single-Dose Study to Determine the Maximum-Tolerated Dose of an Orally
Administered Medication in Healthy Adult Male Volunteers.
The Comparative Steady-State Bioavailability of Theo-24 and Theo-Dur in Healthy Adult
Male Subjects.
A Single-Dose, Food Effects/Bioequivalence Study of Two Ketoprofen Formulations.
A Double Blind, Placebo-Controlled, Dose Tolerance Study to Assess the Effects of
Fluticasone Propionate Aqueous Nasal Spray versus Oral Prednisone on the HPA Axis.
A Rising, Multiple-Dose Study to Determine the Maximum-Tolerated Dose of Orally
Administered SP-303 in Healthy Adult Male Volunteers.
Relative Bioavailability of the Phase III Tablet, Marketed-Image Tablet, and the
Marketed Tablet in Healthy Adult Male Subjects.
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