CLINICAL INQUEST CENTER LTD _____________________________________________________ http://www.cic-america.com DANIEL WHITMER, MD Principal Investigator List of Trials Research Experience: Cardiovascular: A Dose-Ranging Study of XXX in Patients with Primary Hypercholesterolemia. XXX Cardiovascular Treatment Assessment vs YYY A Randomized, Double-Blind, Active-Controlled Evaluation of the Antihypertensive Response to XXX in Subjects Uncontrolled on Calcium-Channel Blocker Therapy. A Randomized, Double-Blind, Active-Controlled Evaluation of the Antihypertensive Response to XXX in Subjects Uncontrolled on Ace Inhibitor Therapy. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Elective Titration Design Study of XXX in Subjects with Uncontrolled Hypertension. A Randomized, Double-Blind, YYY- and ZZZ-Dontrolled Study of XXX in Subjects with Mild to Moderate Hypertension. Evaluation of the Efficacy and Tolerability of XXX in Hypertensive Patients across Several Aspects of Patient Demographics. An Open-Labeled, Community-Based Clinical Practice Study of XXX n Patients with Hyperlipidemia. A Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Weekly XXX on the Incidence of Coronary Artery Disease in Subjects with Evidence of Exposure to C. Pnuemoniae Caring for Hypertension on Initiation: Costs and Effectiveness Endocrinology: A Multi-National, Randomized, Double-blind, Placebo controlled, Forced Titration, 2x2, Factorial Designed Study of the Efficacy and Safety of Long-Term Administration of CLINICAL INQUEST CENTER LTD _____________________________________________________ http://www.cic-america.com XXX and YYY in the Prevention of Diabetes and Cardiovascular Outcomes in Subjects with Impaired Glucose Tolerance (IGT). A Double-Blind Randomized Study to Evaluate the Effects of Fixed Combination Metformin/Glipizide Therapy in Dubjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic control on Half-Maximum of the Labeled Doses of Sulfonylurea Monotherapy. A Multicenter, Randomized, Double-Blind, Active Control trial to Compare the Safety and Efficacy of a New Formulation of XXX to YYY Monotherapy as First Line Therapy in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With Diet and Exercise A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of YYY Added on to a Background of XXX/ZZZ Tablets in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on XXX/ZZZ Therapy A Multicenter, Randomized, Double-Blind, Active Control Trial to Evaluate the Safety and Efficacy of XXX Product as First Line Therapy in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control with Diet and Exercise. A Double-Blind, Randomized Study of the Safety and Efficacy of a Combination of Insulin and 45mg of XXX Compared to Combination of Insulin and 30mg of XXX in the Treatment of Patients with Type 2 (Non-Insulin Dependent) Diabetes Mellitus. CLINICAL INQUEST CENTER LTD _____________________________________________________ http://www.cic-america.com A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Clinical Evaluation of XXX (2.5mg, 5mg, and 7.5mg) as Monotherapy for 26 Weeks in Subjects with Type 2 Diabetes Mellitus. A Phase III, Randomized, Double-Blind, Active Control Trial to Evaluate the Safety and Efficacy of a Fixed Combination XXX/YYY Product in Patients with Type 2 Diabetes Mellitus who have Inadequate Glycemic Control on Maximum Dose Sulfonylurea Monotherapy. Safety and Efficacy oof Fixed Combination XXX/YY Products as First Line Therapy in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control with Diet, Exercise and Maximum Doses of Sulfonylurea Therapy. Safety and Efficacy of Fixed Combination XXX/YYY Products As First Line Therapy in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With Diet and Exercise. An Open Label, Long-Term Extension Study of XXX in type 2 Diabetes Mellitus Patients (Non-Insulin Dependent Diabetes Mellitus, NIDDM). A Randomized, Double-Blind Placebo-Controlled Six month Safety and Efficacy Trial of 2 mg TID of XXX as Adjuctive Therapy to a Sulfonylurea Compared to a Sulfonylurea Alone in Type II Diabetes Mellitus Patients” A phase 3 randomized double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of ranolazine when added to medformin in subjects with type II diabetes mellitus. A phase 3 randomized double-blinded, placebo-controlled, parallel group study to evaluate the safety and efficacy of Ranolazine when added to glimiperaide in subjects with type II diabetes mellitus. A Double-Blind, Placebo-Controlled, Randomized Study of the Safety and Efficacy of a Combination of Insulin and Two Doses of XXX in the Treatment of Patients with NonInsulin Dependent Diabetes Mellitus (NIDDM). A Double-Blind, Placebo-Controlled, Randomized Study of the Safety and Efficacy of a Combination of Metformin and 30 mg of XXX in the Treatment of Patients with NonInsulin Dependent Diabetes Mellitus (NIDDM). CLINICAL INQUEST CENTER LTD _____________________________________________________ http://www.cic-america.com A Double-Blind Placebo Controlled Randomized Study of the Safety and Efficacy of a Combination of Sulfonylurea and 30 mg of XXX in the Treatment of Patients with NonInsulin Dependent Diabetes Mellitus (NIDDM). A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the safety and efficacy of drug (monotherapy) in subjects with type II diabetes mellitus. . A Multicenter, Double-Blind, Placebo-Controlled Group Comparison Study to Investigate the Efficacy, Tolerability and Safety of XXX Glucosidase Inhibitor as Compared to a Mixed Dose of Sulfonylurea Alone and in Combination with XXX Glucosidase Inhibitor in Treatment of Patients with Mild Non-Insulin Dependent Diabetes (type II) Inadequately Controlled by Diet Alone. A One-Year Multicenter, Double-Blind, Randomized, Parallel Group Comparison Extension Study to investigate the Long-Term Efficacy, Tolerability and Safety of XXX as Compared to a fixed Dose of XXX Alone and in Combination with XXX in the Treatment of Patients with Non-Insulin-Dependent Diabetes Mellitus. Gastroenterology: A Twelve Week Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Tolerability of XXX 1mg Twice Daily for Control of Bowel Urgency in Females with Diarrhea-Predominant Irritable Bowel Syndrome. A Randomized, Double-Blind, Placebo-Controlled study to access the efficacy and safety of drug in OIC patients with non-cancer related pain. Sponsor: Astrazeneca. A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients with diarrhea-Predominant Irritable Bowel Syndrome. Gynecology: A Randomized, Double-Blind, 36 Week Trial Comparing Impact of Breakthrough postmenopausal Women on XXX and YYY in a Managed Care Setting. A Study Comparing Piroxicam-Beta-Cyclodextrin, Naproxen Sodium, and Placebo in the Triatmeno of Moderate or Severe Abdominal pain Associated with Primary Dysmenorrhea. CLINICAL INQUEST CENTER LTD _____________________________________________________ http://www.cic-america.com A Randomized, Investigator-Blind, Placebo-Controlled, Parallel Design, Multiple-Site Study Comparing TEVA Pharmaceuticals Estradiol Vaginal Tablets with Vagifem® (Estradiol) Vaginal Tablets (Novo Nordisk) in the Treatment of Atrophic Vaginitis Infectious Disease: Comparative Study of the Safety and Efficacy of XXX to YYY In the Treatment of Streptococcal Pharyngitis/Tonsillitis A Randomized, Double-Blind, Multi-Center, Comparative Phase III Study of XXX vs YYY in the Treatment of Community-Acquired Pneumonia A Randomized, Double-Blind, Multi-Center, Comparative Phase III Study of XXX vs YYY in the Treatment of Acute Exacerbation of Chronic Bronchitis A Randomized, Double-Blind, Multi-Center, Comparative Phase III Study of Two Dosing Durations of XXX vs YYY in the Treatment of Acute Sinusitis A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy Based on the Time to Treatment of Influenza Infection with the Neuraminidase Inhibitor XXX. A Randomized, Double-Blind, Multicenter Comparison of the Efficacy and Safety of XXX vs. YYY in the Treatment of Outpatients with Community Acquired Pneumonia. A Double-Blind, Placebo-Controlled, Exploratory Safety and Efficacy Evaluation of XXX in the Treatment of Enteroviral Upper Respiratory Tract Disease. (“Summer Flu”) Comparative Safety and Efficacy of XXX and YYY in the Treatment of Patients with Streptococcal Pharyngitis. Comparative Safety and Efficacy of XXX and YYY in the Treatment of Acute Bacterial Exacerbation of Chronic Bronchitis. A Multicenter, Double Blind, Placebo-Controlled Trial for Safety and Efficacy Evaluation of XXX in the Treatment of Viral Syndrome. Comparative Safety and Efficacy of XXX and YYY in the Treatment of Patients with Uncomplicated Skin or Skin Structure Infection. CLINICAL INQUEST CENTER LTD _____________________________________________________ http://www.cic-america.com Neurology: A Multicenter, Randomized, Open-Label Comparison of the Effects of XXX and Usual Migraine Care On Work Loss, Productivity, and Patient Preference. An Open, Randomized, Parallel-Group, Multicenter Trial to Compare a Stratified Care Treatment Regimen based on Migraine Disability (MIDAS grade) versus Standard Therapy for the Acute Treatment of Migraine Headache. XXX: a Long-Term, Open-Label Safety Study of XXX 12.5 mg Orally in Migraine Patients. Otolaryngology: A Phase II, Double-Blind, Placebo-Controlled, Randomized, Multicenter, Parallel Study of XXX Nasal Spray, 2% Suspension for the Treatment of Natural Rhinovirus Infection in the General Population Including Patients with a History of Chronic Respiratory disease. Pain Management: Analgesic efficacy of XXX Versus YYY in Opoid Naïve and Opiod experienced Chronic Pain Patients. A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter trial of (drug) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation ( Management of Drug) in Opioid-experienced Subjects with Uncontrolled Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation who Require Around-the-clock Opioid Therapy. A Study Comparing XXX, YYY and Placebo in Treatment of Moderate or Severe Abdominal Pain Associated with Primary Dysmenorrhea A Randomized, Double-Blind Placebo-Controlled Multicenter Study of Single Dose XXX 8mg and Single Dose XXX 16mg for the Treatment of Opioid-induced Nausea and Emesis in Subjects Experiencing Acute Pain. A Phase 3, double-blind, placebo-controlled, multicenter, randomized withdrawal study to evaluate the analgesic efficacy, safety, and tolerability of XXX in opioid naïve subjects with moderate to severe chronic low back pain requiring around the clock opioid analgesia for an extended period of time. CLINICAL INQUEST CENTER LTD _____________________________________________________ http://www.cic-america.com A phase 3 double blind, placebo-controlled multicenter, randomized withdrawal study to evaluate the analgesic efficacy, safety and tolerability of XXX in opioid experienced subjects with moderate to severe chronic low back pain requiring around the clock opioid analgesia for an extended period of time. Renal: An Open Label, Randomized, Multicenter, Phase III, Comparator Controlled Parallel group Study to Assess the Long-Term Safety and Efficacy of XXX in Chronic Renal Failure Patients Receiving Hemodialysis. Rheumatology: A Multicenter Double-blind Study to Evaluate the Safety and Efficacy of XXX and YYY in Subjects with Rheumatoid Arthritis using Methotrexate. A Multicenter, Blinded, Randomized, Placebo Controlled Trial to Study the Ability of XXX to Retard Joint Destruction, and Evaluate the Long Term Safety of XXX in Subjects with Rheumatoid Arthritis A Comparison of the Analgesic Efficacy and Safety of XXX Versus Placebo for the Treatment of a Painful Flare of Osteoarthritis. A Comparison of the Analgesic Efficacy and Safety of XXX /YYY Versus Placebo for the Treatment of a Painful Flare of Osteoarthritis. A Randomized, Double-Blind, Multicenter Study to Evaluate the Tolerability and Effectiveness of XXX 25mg q.d. vs. YYY 500mg b.i.d. in Patients with Osteoarthritis.” A 14-Day Study Comparing the Safety of Two Dosing Regimens of XXX in Patients with Osteoarthritis. A Double-Blind, Placebo-Controlled, Randomized Comparison Study of the Efficacy and Safety of XXX BID and YYY 500mg BID in Treating the Sign and Symptoms of Osteoarthritis of the Hip. A Multicenter, Double-Blind, Placebo-Controlled, Randomized Comparison Study of the Efficacy and Upper Gastrointestinal Safety of XXX BID and YYY 500mg BID in Treating the Sign and Symptoms of Osteoarthritis. CLINICAL INQUEST CENTER LTD _____________________________________________________ http://www.cic-america.com A Multicenter Double Blind Placebo Controlled Randomized Comparison Study of the Efficacy and Upper Gastrointestinal Safety of XXX BID and YYY 500mg BID in Treating the Sign and Symptoms of Rheumatoid Arthritis. Clinical Protocol to Evaluate the Long-Term Safety of XXX in Treating the Signs and Symptoms of Osteoarthritis and Rheumatoid Arthritis. Urology: Prospective, Randomized, Double-Blind, Multi-Center, Comparative Trial to Evaluate the Efficacy and Safety of XXX Tablets QD for 3 Days Versus Conventional YYY Tablets BID for 3 Das in the Treatment of Patients with Uncomplicated Urinary Tract (uUTI) Infections. Development of an Instrument to Assess Quality of Life in Patients with Nocturia.