Our Trials at ARA

Research Experience

Cardiology

Angina

A Double-Blind, Placebo-Controlled, 4-Period Cross-Over, Multiple-Dose Study of XXXX as Monotherapy for Chronic Stable Angina Pectoris at Doses of 500 mg bid, 1000 mg bid, and 1500 mg bid.

Arrhythmia

A Multi-Center Open-Label Clinical Trial to Assess the Long-Term Safety of a Daily Oral Dose of 125 mg XXXX in Patients with Atrial Fibrillation/Flutter and/or Paroxysmal Supraventricular Tachycardia.

A Double-Blind, Placebo Controlled, Parallel Design Study to Determine the Effect of 75 mg or 100 mg of Orally Administered XXXX versus Placebo on Survival in Recent Post-Myocardial Infarction Patients at Risk of Sudden Death.

A Multi-Center Open Label Clinical Trial to Assess the Efficacy and Safety of 50 mg, 100 mg, 125 mg, of XXXX for the Prophylactic Treatment of Symptomatic Atrial Fibrillation/Flutter and/or Paroxysmal SupraVentricular Tachycardia

A Multi-Center Double-Blind, Placebo-Controlled, Parallel Design Clinical Trial to Assess the Efficacy and Safety of 50 mg, 100 mg, 125 mg, of XXXX for the Prophylactic Treatment of Symptomatic Atrial Fibrillation/Flutter and/or Paroxysmal SupraVent Tach.

Myocardial Infarction

PK Sub-Study of Double-Blind, Placebo Controlled, Multinational Trial to Investigate the Effect of Na+/H+ Exchange Inhibitor on All-Cause Mortality and MI in Patients At Risk of Myocardial Necrosis Due to Acute Coronary Syndrome.

A Randomized, Double-Blind, Placebo Controlled Trial of the Effect of Weekly XXXX on the Incidence of Coronary Artery Disease in Subjects with Evidence of Exposure to C. Pneumoniae Echo Substudy of Double-Blind, Placebo Controlled, Multinational Trial to Investigate the Effect of Na+/H+ Exchange Inhibitor on All-Cause Mortality and MI in Patients At Risk of Myocardial Necrosis Due to Acute Coronary Syndrome.

A Multi-Center Open Label Clinical Trial to Assess the Efficacy and Safety of 50 mg, 100 mg, 125 mg, of XXXX for the Prophylactic Treatment of Symptomatic Atrial Fibrillation/Flutter and/or Paroxysmal SupraVentricular Tachycardia

A Double-Blind, Placebo-Controlled, Multinational Trial to Investigate the Effect of the Na+/H+ Exchange Inhibitor XXXX on All-Cause Mortality and Myocardial Infarction in Patients At Risk Of Myocardial Necrosis Due to Acute Coronary Syndrome.

Dermatology

Skin Infection

Investigational drug vs. Clarithromycin for the treatment of uncomplicated skin and superficial skin structure infections.

Endocrinology

Diabetes Mellitus

A Multicenter, Double- Blinded, Randomized, Parallel Group, Fixed Dose Study to Evaluate the Safety, Efficacy, and Tolerability of Two Doses of XX Compared to XX in Subjects with Type 2 Diabetes Previously Treated with Diet and Sulfonylureas.

Safety and Efficacy of Fixed Combination XXXX/XXXX Products as First Line Therapy in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control with Diet and Exercise.

A Double-Blind, Randomized, Parallel-Group Study to Prospectively Evaluate the Efficacy, Safety, and Tolerability of XXXX Monotherapy, Metformin Monotherapy, XXXX plus Metformin Comb. Therapy, and Placebo in Subjects with NIDDM.

A Double-Blind, Randomized, Parallel-Group Study To Prospectively Evaluate The Efficacy Safety And Tolerability Of XXXX in the Treatment of NIDDM.

Double-Blind, Randomized, Parallel-Group Study To Prospectively Evaluate The Efficacy, Safety and Tolerability Of XXXX Monotherapy Metformin Monotherapy XXXX Plus Metformin Combination.

A randomized comparator, controlled. double blind study of the liver safety of XXXX HCL versus Gluburyde with Metformin and Insulin as part of step therapy in subjects with Type II (Non Insulin Dependent) Diabetes.

Diabetic Gastroparesis

Extension Study A Long- Term Open- Label Clinical Trial Evaluating the Safety and Efficacy of XXXX for the Treatment of PDS Associated with Insulin- Requiring Diabetics.

A Dose- Ranging Clinical Trial Evaluating the Efficacy and Safety of XXXX for the Treatment of PDS Associated with Insulin-Dependent Diabetes.

Diabetic Nephropathy

A Study of the Antiproteinuric Effects of XXXX and XXXX in Type II Diabetics with Hypertension and Microalbuminuria or Overt Nephropathy.

A Double-Blind Randomized, Placebo-Controlled Study to Evaluate the Renal Protective Effects of XXXX in Patients with Noninsulin Dependent Diabetes Mellitus and Nephropathy.

Gastroenterology

Constipation

A Multicenter, Multinational, Open- Label, Extension Study of Oral XXXX for the Treatment of Opioid- Induced Constipation in Patients with Chronic, Non- Malignant or Malignant Pain.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of Oral XXXX for the Treatment of Opioid-Induced Constipation in Patients with Chronic, Non-Malignant Pain.

Gastric Ulcer/Ulcer Prevention

A comparative Efficacy and Safety Study of XXXX (xxxx) Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine (150 mg bid) for the healing of NSAID-associated Gastric Ulcers When Daily NSAID Use is Continued.

A Comparative Efficacy and Safety Study of XXXX (xxxx) Delayed-Release Capsules (40mg qd and 20 mg qd) Versus Placebo for the healing of NSAID-associated Gastric Ulcers When Daily NSAID is Discontinued.

A Comparative Efficacy and Safety Study of XXXX (xxxx) Delayed-Release Capsules (40mg qd and 20mg qd) Versus Placebo for the Prevention of Gastric Ulcers Associated with Daily NSAID Use in Patients at Risk

Dyspepsia

A Double-Blind, Randomized, Placebo-Controlled Phase II Clinical Trial of XXXX for Treatment of Non-Ulcer Dyspepsia in Patients With Helicobacter Pylori.

A Double-Blind, Randomized, Placebo-Controlled Phase II Clinical Trial of XXXX for Treatment of Non-Ulcer Dyspepsia in Patients Without Helicobacter Pylori.

Development of a new dyspepsia impact scale (NDI - nepean dyspepsia index)

Erosive Esophagitis

A comparative Efficacy Study of XXXX (40 mg qd) and XXXX (30 mg qd) in patients with erosive Esophagitis

A Comparative efficacy Study and Safety Study of XXXX (40mg) and Omeprazole (20mg) in Study Subjects with Erosive Esophagiti

A Multicenter, Open-Label, Long Term Safety Study of XXXX in Subjects with Healed Erosive Esophagitis.

A Multi-Center, Randomized, Double-Blind, Eight Week Comparative Efficacy and Safety Study of XXXX and Omeprazole 20mg in Study Subjects with Erosive Esophagitis.

Provocative Meal

A multi-center, double-blind, randomized, single-dose, placebo-controlled study to investigate the efficacy and safety of 2 doses of XXXX in preventing meal-induced heartburn symptoms following a provocative meal.

Ulcerative Colitis

A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of XXX and Asacol in Patients with Active, Mild to Moderate Ulcerative Colitis

IBS

A twelve-week, randomized. double blind, placebo controlled, parallel-group, dose ranging, phase II study to assess the clinical efficacy of XXXX (XXXX)#) in male subjects with Irritable Bowel Syndrome.

A 12-week, randomized, double blind, placebo controlled, study of XXXX in female Subjects with alternating diarrhea/constipation Irritable Bowel Syndrome.