Jeffrey D. Wayne, MD Curriculum Vitae California License #G65909 DEA License #BW1848211 Principal Investigator - Owner | Clinical Trials Research
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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR Jeffrey D. Wayne, MD Curriculum Vitae California License #G65909 DEA License #BW1848211 Principal Investigator - Owner | Clinical Trials Research Clinical Trials Research Investigators 160 Gateway Drive, Suite 100 Joseph D. Hobbs, PA-C Lincoln, CA 95648 Robyn Lawrie, NP (916) 434-8230 Phone Sharmila Chatterjee, MD, MPH (916) 434-8237 Fax H. Douglas Cooper, MD (Ophthalmology) 3750 Auburn Boulevard, Suite A Research Coordinators Sacramento, CA 95821 (916) 434-8230 Phone Leesa Koskela, CCRC (Clinical Director) (916) 487-8237 Fax Tammy Ward, CRC Marissa Tangerini, BS, CCRC Stacey Adams, CRC Kari Sue Jones, CCRC Kadijah Washington, CRC Education 1978-1982 University of Southern California Keck School of Medicine – MD Degree 1974-1978 Emory University Atlanta, GA – BA Psychology Professional Experience 1999-Present Clinical Trials Research, Owner/Principal Investigator 1992-Present Clinical Trials, Principal Investigator 1989-Present Internal Medicine (Private Practice), Owner 1 | P a g e Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR 2006-2007 Howe Medical Clinic, Medical Director 1997-1999 Sacramento Health and Weight Management, Inc, Medical Director 1986-1989 Faulkner Hospital, ER Attending Physician, Clinical Instructor Professional Training 1983-1986 Residency – Internal Medicine – Faulkner Hospital Tufts University School of Medicine, Boston, Mass Board Certified in Internal Medicine - 1987 1982-1983 Internship – Family Practice – University of Southern California Presbyterian Intercommunity Hospital Family Medicine Program at Los Angeles County Hospital Clinical Research Experience 28 years conducting clinical trials as Principal Investigator in multiple therapeutic areas including but not limited to hypertension, diabetes, cardiovascular, respiratory, women’s health, men’s health. Approximately 260 trials completed. Academic Appointments and Memberships Present Appointment 2014-Present Volunteer Clinical Faculty, University of California, Davis School of Medicine Previous Appointments 1999-2016 Office based staff member, Mercy San Juan Hospital 1999-2008 Senior staff member, Sutter Roseville Medical Center 1992-2005 Qualified Medical Examiner, State of California, Industrial Medical Council 2 | P a g e Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR 1999-2008 Medical Director, Eskaton Home Care 1996-1997 Clinical Preceptor, University of San Francisco School of Nursing, Nurse Practitioner Program 1992-1994 Director of Clinical Research, Sutter Medical Group 1991-1993 Clinical Preceptor, University of California, Davis, Medical Center Physician Assistant Program 1989-1999 Senior Staff Member, Mercy American River Hospital and Mercy San Juan Hospital 1986-1989 Clinical Instructor, Tufts University School of Medicine Clinical Trials TAP Pharmaceuticals Generalized Anxiety Disorder Study. Double-Blind, Fixed Dose Multicenter Study Comparing XXXX to XXXX and Placebo in Patients with Generalized Anxiety Disorder. Merck Sharpe and Dohme Ace Inhibitor Cough Study. A Multicenter, Double-Blind, Randomized, Parallel Group Study to Investigate the Incidence of Cough in Patients Receiving XXXX or XXXX who have Reported Cough with an Angiotensin Converting Enzyme Inhibitor. Norwich-Eaton Urinary Tract Infection (UTI) Study. An Open Label, Multicenter Study to Compare the Safety and Efficacy of XXXX for Seven Days to XXXX for Ten Days in the Treatment of Acute, Uncomplicated Lower Urinary Tract Infections. Ciba-Geigy Corporation Hypertension Study. A Randomized, Doub1e-B1ind, Parallel Trial Comparing XXXX, XXXX, and XXXX in Patients Age 18-80 Years with Essential Hypertension Inadequately Controlled with XXXX Followed by a Single-Blind Extension of XXXX. 3 | P a g e Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR Medeva Hepatitis Study. A Multicenter, Randomized, Double-Blind Study in Normal, Healthy Subjects to evaluate the Efficacy and Safety of Two-Dose, One Month Regimen of XXXX Compared to XXXX and to a Three Dose, Two Month Regimen of XXXX. TAP Holdings Dyspepsia Study. A Study to Evaluate the Effects of XXXX 30 mg or 15 mg QD versus Placebo in Patients with Non-Ulcer Dyspepsia. Glaxo Wellcome Chronic Bronchitis Study. A Randomized, Double-Blind Multicenter Comparison of the Efficacy and Safety of XXXX 400 mg or 600 mg Once Daily and XXXX 500 mg Twice Daily in the Treatment of Patients with Acute Bacterial Exacerbations of Chronic Bronchitis. Novartis Pharmaceuticals Diabetes Study. A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Efficacy, Tolerability and Safety of XXXX Monotherapy, XXXX Monotherapy and a Combination of XXXX and XXXX to Placebo in Subjects with Non- Insulin Dependent Diabetes Mellitus Inadequately Controlled on Diet Alone. TAP Holdings GERD Study. Study to Evaluate the Effects of XXXX 5 mg QID, 10 mg TID, 20 mg BID Versus Placebo in Females with Non-Erosive Gastroesophageal Reflux Disease. Kos Pharmaceuticals Lipid Study. A Long-Term, Open-Label, Multicenter Trial of the Safety and Efficacy of Nicostatin in Patients with Dyslipidemia. Medeva Hepatitis Study. A Multicenter, Long-Term, Follow-up Study of the Duration of Seroprotection After XXXX, and an Open-Label Study of the Efficacy and Safety of a Single Dose of XXXX in Subjects with Low XXXX Values. Berlex Laboratories Menopause Study. A Multicenter, Double-Blind, Randomized Study of Continuous XXXX Combinations, Compared to Continuous XXXX, to Examine the Safety and Effect on the Endometrium, Symptoms and Bleeding Patterns in Postmenopausal Women. 4 | P a g e Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR Merck & Co. Osteoarthritis Study. A Randomized, Double Blind, Multicenter Study to Evaluate the Tolerability and Effectiveness of XXXX 25 mg qd vs XXXX 500 mg bid. in Patients with Osteoarthritis. Novartis Pharmaceuticals Diabetes Study. A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Evaluate the Efficacy, Safety and Tolerability of Three Fixed Dose Levels of Nateglinide and Placebo in Type 2 Diabetes Mellitus patients with Minimally Elevated Fasting Plasma Glucose Levels. TAP Pharmaceuticals Irritable Bowel Syndrome (IBS) Study. A Study to Evaluate the Safety and Efficacy of XXXX (30 mg BID, 60 mg BID and 120 mg BID) vs XXXX in Subjects with Irritable Bowel Syndrome. Novartis Pharmaceuticals Functional Dyspepsia and Delayed Gastric Emptying Study. A Randomized, Double- Blind, Placebo-Controlled, Dose Finding, Multicenter Study to Assess, the Efficacy, Safety and Tolerability of XXXX Given Orally at Three Dose Levels (1 mg, 4 mg or 12 mg), and XXXX in Patients with Functional Dyspepsia (FD) and Documented Normal Gastric Emptying. Novartis Pharmaceuticals Functional Dyspepsia and Delayed Gastric Emptying Study. A Randomized, Double- Blind, Placebo-Controlled, Dose Finding, Multicenter Study to Assess the Efficacy, Safety and Tolerability of XXXX Given Orally at Three Dose Levels (4mg, 12 mg or 24 mg) and XXXX in Patients with Functional Dyspepsia (FD) and Documented Delayed Gastric Emptying. Takeda Pharmaceuticals North America Diabetes / CHF Study. A Randomized, Double-Blind, Comparator-Controlled Study of XXXX vs XXXX in the Treatment of Subjects with Type 2 (Non-Insulin Dependent) Diabetes Mellitus and Mild to Moderate Congestive Heart Failure. Takeda Pharmaceuticals North America Diabetes / Cardiovascular Study. A Randomized, Double-Blind, Comparator-Controlled Study of XXXX vs. XXXX in the Treatment of Subjects with Type 2 (Non-Insulin Dependent) Diabetes Mellitus and Mild Cardiac Disease (NYHA I). 5 | P a g e Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR Bertek Pharmaceuticals Hypertension Study. A Double-Blind, Multicenter, randomized, Placebo Controlled, Parallel Group Study of the Efficacy and Safety of XXX Added to Existing Antihypertensive Treatment in Patients with Mild to Moderate Hypertension. Eli Lilly Diabetic Peripheral Neuropathy Study. LY333531 Treatment of Peripheral Neuropathy in Patients with Diabetes. Bristol-Myers Squibb Diabetes Study. A Randomized, Double-Blind, Dose Ranging, Dose Comparison- Controlled Trial to Determine the Safety and Efficacy of XXXX in Patients with Type 2 Diabetes Solvay Pharmaceuticals Irritable Bowel Syndrome Study. A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Investigate the Safety and Efficacy of 2 mg TID of Cilansetron over 12 Weeks Followed by a 4-week XXX Treatment Period in Diarrhea-Predominant Irritable Bowel Syndrome Subjects. Novartis Pharmaceuticals African American Hypertension Study. A Double-Blind, Randomized, Parallel Group Study Comparing the Effects of XXX to XXX in African American Patients with Mild to Moderate Hypertension. Novartis Pharmaceuticals Impaired Glucose Tolerance (IGT) Study. A Multinational, Randomized, Double-Blind, Placebo-Controlled, Forced-Titration, 2 X 2 Factorial Design Study of the Efficacy and Safety of Long Term Administration of XXX and XXXX in the Prevention of Diabetes and Cardiovascular Outcomes in Subjects with Impaired Glucose Tolerance (IGT). Novartis Pharmaceuticals Hypertension Study. A Multicenter Prospective, Randomized, Open-Label, Blinded End-Point, Parallel Group Study Comparing the Effects of XXX(5/20mg) to XXXX (5 mg) and XXXX (20 mg) on Systolic Blood Pressure and Pulse Pressure in Patients with Systolic Hypertension. Takeda Pharmaceuticals North America Congestive Heart