Research Portfolio — AIM Research

150+clinical trials completed

106documented on this page

70registered on ClinicalTrials.gov

2002–2020execution window

Atlanta Institute for Medical Research was incorporated in 2002 as an independent clinical research firm specializing in critical care, infectious disease, pulmonary, and cardiology trials. Over its first dozen years the firm successfully completed more than 150 clinical trials, negotiated more than $5M in sponsor contracts, and passed an FDA audit with no findings. The portfolio below merges a current ClinicalTrials.gov pull (70 verified NCTs) with 36 additional protocols documented in AIM's authoritative study list that predate the September-2007 FDAAA registration mandate or do not resolve to a current CT.gov record. A separate section covers studies conducted through the NIH-funded Antibacterial Resistance Leadership Group (ARLG), coordinated by Duke University.

Lead sponsors across the full portfolio include Bristol-Myers Squibb (apixaban/Eliquis — ARISTOTLE and AMPLIFY), Eli Lilly (tadalafil/Adcirca — PHIRST-1; drotrecogin/Xigris), GSK (Advair/Ariflo/Lovaza; SFA103153 asthma), Gilead (ambrisentan/Letairis), Pfizer (sitaxsentan/Thelin; dalteparin; A7331009), Roche (baloxavir/Xofluza), AstraZeneca (Symbicort; roflumilast), Johnson & Johnson, Takeda (TAK-242 sepsis), Novartis (vildagliptin), Abbott Nutrition (NOURISH), Cubist/Merck (daptomycin/Cubicin), Basilea (ceftobiprole), Theravance (telavancin), Sunovion (eszopiclone/Lunesta — DREAMDD), KCI (Vacuum Assisted Closure), Angiotech, Boehringer Ingelheim, Astellas, Epix, Encysive, Eisai, Optimer (fidaxomicin), BioCryst (peramivir), Duke University, and NIAID (NIH).

Jump to: Federal networkNIH Infectious Disease & Antimicrobial33 Pulmonary & Respiratory23 Cardiology & Thrombosis9 Sedation2 Nutrition1 Wound Care1 Metabolic / Diabetes1 Earlier protocols36

Federal network affiliations

NIH / ARLG

AIM Research participated in the Antibacterial Resistance Leadership Group (ARLG), a clinical trials network funded by the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health, coordinated by Duke University. Active and pending ARLG studies at AIM Research included:

·Phase 1

ACUMIN — Minocycline Pharmacokinetics in Critically Ill Adults

Critical care, antimicrobial pharmacokinetics

NCT03369951

·Phase 2

SAATELLITE — Human Monoclonal Antibody Against Staph aureus Alpha Toxin in Mechanically Ventilated Adults (MEDI4893)

Staphylococcus aureus pneumonia prevention

NCT02296320

EVADE — Prevention of Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa in Mechanically Ventilated Subjects (MEDI3902)

ARLG / Duke

PROPEL — Plasma and Epithelial Lining Fluid Pharmacokinetics of IV Plazomicin in Ventilated Pneumonia

ARLG / Duke

pNAAT — Performance of Nucleic Acid Amplification Testing for Detection of Neisseria gonorrhoeae and Chlamydia trachomatis in Extra-Genital Sites

ARLG / Duke

HAP/VAP Adult — Hospital-Acquired and Ventilator-Associated Pneumonia (enrollment completed)

Duke / ARLG network

HAP/VAP Pediatric — Hospital-Acquired and Ventilator-Associated Pneumonia, Pediatric

Duke / ARLG network

Infectious Disease & Antimicrobial

33 trials

·Phase 2·2001–2003

Phase II, Randomized, Open-Label, Multi-Center Study to Evaluate the Safety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter-Related Bloodstream Infections With Suspected or Confirmed Gram-Positive Bacterial Pathogens

Bacteremia

NCT00057369Unknown

·Phase 3·2001–2004

A Multicenter, Randomized, Double Blind, Comparative Trial of Intravenous MERREM (Meropenem, ICI 194,660) vs PRIMAXIN I.V. (Imipenem-cilastatin) in the Treatment of Hospitalised Subjects With Complicated Skin and Skin Structure Infections.

Skin Infection, Abscess

NCT00619710Completed

·Phase 2·from 2002

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Hospitalized Patients With Community-Acquired Pneumonia and Sepsis

Pneumonia, Sepsis

NCT00042588Completed

·Phase 4·from 2002

The Study of Drotrecogin Alfa (Activated) in a Subpopulation of Adult Patients With Severe Sepsis

Sepsis

NCT00045760Completed

·Phase 3·2002–2006

Multi-center Clinical Trial of the Bard Silver-coated Endotracheal Tube to Reduce Ventilator Associated Pneumonia (VAP)

Respiratory Failure

NCT00148642Completed

·Phase 4·2002–2005

A Randomized, Double-Blind, Placebo-Controlled Trial of Prophylactic Heparin in Patients With Severe Sepsis and Higher Disease Severity Who Are Undergoing Treatment With Drotrecogin Alfa (Activated)

Sepsis

NCT00049777Completed

·Phase 3·2004–2007

A Phase IIIb Study to Determine Efficacy and Safety of Extended Drotrecogin Alfa (Activated) Therapy in Patients With Persistent Requirement for Vasopressor Support After 96 Hour Infusion With Commercial Drotrecogin Alfa (Activated)

Sepsis, Hypotension

NCT00190788Completed

·Phase 2·2004–2007

A Prospective, Randomized, Double-blind, Placebo Controlled, Dose Ranging, Multi-Center Study of the Safety and Efficacy of Three Days Continuous Intravenous Infusion of GR270773 in the Treatment of Suspected or Confirmed Gram-negative Severe Sepsis in Adults

Sepsis

NCT00089986Completed

·Phase 3·2004–2005

A Phase III, Randomized, Double-Blind Study of Ceftobiprole Versus Comparator in the Treatment of Complicated Skin and Skin Structure Infections

Skin Diseases, Infectious, Skin Diseases, Bacterial

NCT00228982Completed

·Phase 3·2005–2007

A Pivotal, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety of TAK-242 in Adults With Severe Sepsis

Sepsis

NCT00143611Completed

·Phase 3·2005–2007

A Phase 3 Randomized Double-Blind Study Of Ceftobiprole Medocaril Versus Linezolid Plus Ceftazidime In The Treatment Of Nosocomial Pneumonia

Pneumonia

NCT00229008Completed

·Phase 3·2005–2007

A Controlled, Randomized, Single-Blind, Multi-Center Pivotal Clinical Study Using Angiotech CVC to Prevent Bacterial Colonization on Short-Term Central Venous Catheters

Bacterial Infections

NCT00288418Completed

·Phase 4·2006–2006

A Multicenter, Randomized Study Comparing CUBICIN® (Daptomycin for Injection) With Vancomycin in the Treatment of Cellulitis or Erysipelas

Cellulitis

NCT00295178Completed

·Phase 3·2006–2008

A Multi-National, Multi-Center, Double-Blind, Randomized, Parallel Group Study to Compare the Safety and Efficacy of 200 mg PAR-101 Taken q12h With 125 mg Vancomycin Taken q6h for Ten Days in Subjects With Clostridium Difficile-Associated Diarrhea

Clostridium Infections, Diarrhea

NCT00314951Completed

·Phase 3·from 2006

ACCESS: A Controlled Comparison of Eritoran Tetrasodium and Placebo in Patients With Severe Sepsis

Severe Sepsis

NCT00334828Completed

·2006–2007

Multi-Center Clinical Performance Evaluation of a Rapid In Vitro Diagnostic Device for Direct Detection of Staphylococcus Aureus Nasal Colonization: Comparative Analysis to Culture Screening Methods

Staphylococcus Aureus

NCT00406549Completed

·Phase 3·2006–2007

Multicenter, Double-blind Study of Nitazoxanide Compared to Vancomycin in the Treatment of Clostridium Difficile-associated Disease

Clostridium Infections

NCT00384527Terminated

·Phase 2·2007–2007

Phase 2 Multicenter Randomized Semi-Single Blind Study to Compare Efficacy and Safety of High-dose Short Duration Daptomycin With Conventional Therapy in Complicated Skin and Skin Structure Infections Due to Gram-positive Bacteria

Soft Tissue Infections

NCT00426933Completed

·Phase 2·2007–2008

A Phase 2 Study of Doripenem In The Treatment of Nosocomial and Ventilator-Associated Pneumonia In Hospitals

Pneumonia, Bacterial Pneumonia

NCT00502801Completed

·2007–2008

BacLite Rapid MRSA Clinical Performance

Methicillin Resistance

NCT00541632Terminated

·Phase 3·2008–2012

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of Drotrecogin Alfa (Activated) Administered as a Continuous 96-hr Infusion to Adult Patients With Septic Shock

Sepsis

NCT00604214Completed

·Phase 2·2009–2010

A Multicenter, Double-blind, Randomized, Phase 2 Study to Compare the Safety and Efficacy of Intravenous CXA-101 and Intravenous Ceftazidime in Complicated Urinary Tract Infection, Including Pyelonephritis

Complicated Urinary Tract Infection

NCT00921024Completed

·Phase 3·2009–2013

A Phase 3, Multicenter, Randomized, Double-blind, Controlled Study to Evaluate the Efficacy and Safety of Peramivir Administered Intravenously in Addition to Standard of Care Compared to Standard of Care Alone in Adults and Adolescents Who Are Hospitalized Due to Serious Influenza

Cough, Sore Throat

NCT00958776Terminated

·Phase 2·2010–2011

A Randomized, Double-Blinded, Active-Controlled, Dose Ranging Study of CB-183,315 in Patients With Clostridium Difficile Infection.

Clostridium Difficile Infection, Diarrhea

NCT01085591Completed

·Phase 4·2010–2012

A Prospective, Multicenter, Randomized, Evaluator-blinded, Comparator-controlled Study to Describe the Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin Structure Infections (cSSSI) and Staphylococcus Aureus Bacteremia Among Subjects With Moderate or Severe Renal Impairment

Complicated Skin and Skin Structure Infections, S. Aureus Bacteremia

NCT01104662Terminated

·Phase 2·2010–2011

A Randomized, Controlled, Double Blind, Multicenter, Phase 2 Study of the Safety/Tolerability and Efficacy of JNJ-32729463 Compared With Moxifloxacin for the Treatment of Subjects Requiring Hospitalization for Community-Acquired Bacterial Pneumonia (CABP) With a PORT Score of II or Greater

Community-Acquired Bacterial Pneumonia (CABP)

NCT01198626Terminated

·Phase 2·2010–2013

Multi-center, Randomized, Evaluator-blind, Active-controlled,Parallel-group Design to Determine Safety, Tolerability, and Efficacy of Multiple Daily Administration of LFF571 for 10 Days in Patients With Moderate Clostridium Difficile Infections

Moderate Clostridium Difficile Infection

NCT01232595Completed

·Phase 2·2011–2011

A Phase 2 Exploratory Study of Objective Endpoints in Subjects With Acute Bacterial Skin and Skin Structure Infections Treated With Delafloxacin, Vancomycin, or Linezolid

Skin and Subcutaneous Tissue Bacterial Infections

NCT01283581Completed

·Phase 4·2011–2012

A Randomized Study to Evaluate Comparative Effectiveness, Inpatient Resource Utilization, and Cost of Daptomycin vs. Vancomycin in the Treatment of Patients With Complicated Skin and Skin Structure Infections Due to Suspected or Documented Methicillin-resistant Staphylococcus Aureus (MRSA)

Staphylococcal Skin Infections

NCT01419184Completed

·Phase 3·2012–2015

A Randomized, Double-Blinded, Active-Controlled Study of CB-183,315 in Patients With Clostridium Difficile Associated Diarrhea

Clostridium Difficile Infection

NCT01597505Completed

·Phase 3·2012–2015

A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg Every 8 Hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities

Complicated Skin and Soft Tissue Infection

NCT01499277Completed

·Phase 2·2017–2019

A Randomized, Double-Blind, Placebo-Controlled Dose Ranging Study Evaluating Safety, Pharmacokinetics and Clinical Benefit of FLU-IGIV in Hospitalized Patients With Serious Influenza A Infection

Influenza A H3N2, Influenza A H1N1

NCT03315104Completed

·Phase 3·2019–2020

A Phase III, Randomized, Double-Blind Placebo-Controlled, Multicenter Study To Evaluate the Efficacy and Safety of Baloxavir Marboxil in Combination With Standard-of-Care Neuraminidase Inhibitor in Hospitalized Participants With Severe Influenza

Influenza

NCT03684044Completed

Pulmonary & Respiratory

23 trials

·Phase 3·2003–2011

A Long-Term, Open-Label Study To Evaluate The Safety Of Sitaxsentan Sodium Treatment In Patients With Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension

NCT00811018Terminated

·Phase 4·2004–2007

A Multicenter, Randomized, Double-Blind, Parallel Group, 52-Week Comparison of Asthma Control and Measures of Airway Inflammation in Subjects of African Descent Receiving Fluticasone Propionate/Salmeterol 100/50mcg DISKUS® BID or Fluticasone Propionate 100mcg DISKUS® BID Alone

Asthma

NCT00102765Completed

·Phase 3·2004–2007

A Randomized, 24-week, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety and Tolerability of ARIFLO® (15mg BID) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Pulmonary Disease, Chronic Obstructive

NCT00103922Completed

·Phase 3·2005–2007

A 12-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy and Safety Study of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid Compared to Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD

Chronic Obstructive Pulmonary Disease

NCT00206167Completed

·Phase 3·2005–2007

PHIRST-1: Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment in Patients With Pulmonary Arterial Hypertension

Pulmonary Hypertension

NCT00125918Completed

·2005–2006

A Prospective Observational Study for the Psychometric Validation of a Patient-reported Questionnaire in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)

Pulmonary Disease, Chronic Obstructive, Infections, Bacterial

NCT00259909Completed

·Phase 3·2005–2012

An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients With Pulmonary Arterial Hypertension

Hypertension, Pulmonary

NCT00549302Completed

·Phase 3·2006–2008

Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The AURA Study

Chronic Obstructive Pulmonary Disease (COPD)

NCT00297102Completed

·Phase 2·from 2006

A Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled Dose_Ranging Study of Erdosteine for the Treatment of Stable Chronic Bronchitis Associated With Chronic Obstructive Pulmonary Disease

Chronic Bronchitis, Chronic Obstructive Pulmonary Disease

NCT00338507Completed

·Phase 4·2006–2013

Effects of Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Morbidity and Mortality in Symptomatic Patients With Pulmonary Arterial Hypertension - A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Prospective, Event Driven Phase IV Study

Pulmonary Arterial Hypertension

NCT00303459Completed

·Phase 2·2006–2007

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Short-Term Efficacy and Safety of PRX-08066 in Patients With Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease

Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease

NCT00345774Completed

·Phase 3·2006–2009

ARIES-3: A Phase 3, Long-Term, Open-Label, Multicenter Safety and Efficacy Study of Ambrisentan in Subjects With Pulmonary Hypertension

Pulmonary Hypertension

NCT00380068Completed

·Phase 3·2006–2008

Efficacy and Safety of LAS 34273 in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease(COPD)

Chronic Obstructive Pulmonary Disease (COPD)

NCT00358436Completed

·Phase 3·from 2006

Safety and Efficacy of Combivent Respimat in Chronic Obstructive Pulmonary Disease (COPD)

Pulmonary Disease, Chronic Obstructive

NCT00400153Completed

·Phase 4·2006–2007

A Randomized, Double-Blind, Parallel-Group, 12-Week Study to Evaluate the Anti-Inflammatory Effect of Fluticasone Propionate/Salmeterol DISKUS 250/50mcg BID Compared With Salmeterol DISKUS 50mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Pulmonary Disease, Chronic Obstructive

NCT00346749Terminated

·Phase 4·2007–2010

COMPASS 3: An Open-label, Multi-Center Study Employing a Targeted 6-Minute Walk Test (6-MWT) Distance Threshold Approach to Guide Bosentan-Based Therapy and to Assess the Utility of Magnetic Resonance Imaging (MRI) on Cardiac Remodeling

Pulmonary Arterial Hypertension

NCT00433329Completed

·Phase 4·2008–2011

An Open-label, Multicenter Study of Ambrisentan and a Phosphodiesterase Type-5 Inhibitor Combination Therapy in Subjects With Pulmonary Arterial Hypertension Who Have Demonstrated a Sub-Optimal Response to a Phosphodiesterase Type-5 Inhibitor

Pulmonary Arterial Hypertension

NCT00617305Completed

·Phase 4·2008–2010

A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH)

Pulmonary Arterial Hypertension

NCT00430716Terminated

·Phase 3·2008–2010

A Multicenter, Double-blind, Randomized Study Comparing the Safety and Tolerability of Iloprost Inhalation Solution Delivered by I-neb Utilizing Power Disc-15 and Power Disc-6 in Patients With Symptomatic Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension

NCT00709098Completed

·Phase 3·2008–2020

Long-term Single-arm Open-label Extension Study of the SERAPHIN Study, to Assess the Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension

NCT00667823Completed

·Phase 3·2008–2019

ABS-LT: A Phase 3, Long-Term, Open Label, Multicenter Safety Study of Ambrisentan in Subjects With Pulmonary Hypertension

Pulmonary Hypertension

NCT00777920Completed

·Phase 2·2009–2010

A Phase 2a, Randomized, Double Blind, Placebo-controlled, Parallel Group Study Investigating The Dose-response Of Pf-00489791 On Acute Hemodynamics In Subjects With Idiopathic And Familial Pulmonary Arterial Hypertension

Hypertension, Pulmonary

NCT00853112Terminated

·Phase 3·2009–2011

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension

Idiopathic Pulmonary Fibrosis, Pulmonary Hypertension

NCT00879229Terminated

Cardiology & Thrombosis

9 trials

·Phase 3·2006–2010

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess the Efficacy and Safety of Lovaza for the Prevention of Recurrent, Symptomatic Atrial Fibrillation

Fibrillation, Atrial

NCT00402363Completed

·Phase 3·2006–2011

A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Subjects With Nonvalvular Atrial Fibrillation

Atrial Fibrillation, Atrial Flutter

NCT00412984Completed

·Phase 3·2007–2011

A Phase 3 Randomized, Double-Blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.

Venous Thrombosis, Pulmonary Embolism

NCT00457002Completed

·Phase 3·2008–2012

A Safety and Efficacy Trial Evaluating the Use of Apixaban for the Extended Treatment of Deep Vein Thrombosis and Pulmonary Embolism

Venous Thrombosis

NCT00633893Completed

·Phase 3·2008–2013

A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism

Venous Thrombosis

NCT00643201Completed

·Phase 3·2009–2011

Apixaban for Prevention of Acute Ischemic Events - 2 A Phase 3, Randomized, Double-Blind, Evaluation of the Safety and Efficacy of Apixaban In Subjects With a Recent Acute Coronary Syndrome

Acute Coronary Syndrome

NCT00831441Terminated

·Phase 4·2009–2013

FRAG-A001-401: Dalteparin Sodium Injection (Fragmin), Multicenter, Open-Label, Single-arm, Long Term (52 Weeks) Study for Understanding the Safety and Efficacy in Subjects With Malignancies and Symptomatic Venous Thromboembolism

Cancer

NCT00942968Completed

·2010–2014

Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF)

Atrial Fibrillation

NCT01165710Completed

·2016–2018

Eliminate Thromboembolism (ELITE): Improving Anticoagulation in Non-valvular Atrial Fibrillation Patients

Atrial Fibrillation

NCT02461602Completed

Sedation

2 trials

·Phase 3·2004–2005

A Phase III, Randomized, Open-label Study to Assess the Safety and Efficacy of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Flexible Bronchoscopy Procedures

Flexible Bronchoscopy

NCT00209586Terminated

·Phase 3·2004–2005

A Phase III, Randomized, Open-label Study to Assess the Safety and Efficacy of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Minor Surgical Procedures

Arthroscopy, Bunionectomy

NCT00209560Terminated

Nutrition

1 trial

·Phase 3·2012–2014

A Randomized Double Blinded Controlled Trial of an Oral Nutritional Supplement Containing AN 777 in Older Hospitalized Patients

Hospitalized Elderly

NCT01626742Completed

Wound Care

1 trial

·NA·2002–2008

KCI VAC Protocol VAC2001-08, "A Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure Therapy™ in the Treatment and Blinded Evaluation of Diabetic Foot Ulcers"

Diabetic Foot Ulcers

NCT00432965Completed

Metabolic / Diabetes

1 trial

·Phase 3·from 2006

A Multi-center, Randomized, Open-label, Active Controlled, Parallel Arm Study to Compare the Efficacy of 12 Weeks of Treatment With Vildagliptin 100 mg, qd to Thiazolidinedione (TZD) as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy in a Community-based Practice Setting.

Diabetes Mellitus, Type 2

NCT00396227Completed

Additional protocols — pre-registration era

36 trials

Protocols from AIM Research's authoritative study list that executed before the FDA Amendments Act of 2007 (FDAAA) made public registration mandatory, or whose sponsor identifiers do not resolve to a current ClinicalTrials.gov record.

A Phase III, Randomized, Double Blind, Parallel Group, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Hospital-Acquired Pneumonia with a Focus on Patients with Infections Due to Methicillin-Resistant Staphylococcus Aureus.

Protocol 0019

A Prospective, Multicenter, Double-Blind With In-House Blinding, Randomized, Comparative Study to Evaluate the Efficacy, Safety, and Tolerability of Ertapenem Sodium Versus Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections in Hospitalized Adults.

Protocol 037-ERT516

Multi-Center, Clinical Trial of the Bard Silver-Coated Endotracheal Tube to reduce Ventilator Associated Pneumonia: Health Economic Study.

Protocol 5004

Prospective Study to Evaluate the Reliability and Validity of the EXACT (The EXAcerbations of Chronic pulmonary disease Tool)

Protocol A2-4333

Multi-center, Double-blind, Randomized, Active Reference, Parallel Group Study to Evaluate the Efficacy, Safety & Tolerability of 3 Doses of ACT-179811 in Subjects With Clostridium Difficile Infection

Protocol AC-061-A201

A Randomized, Double-Blind, Placebo-Controlled, Phase-2b Study to Assess the Safety and Efficacy Effects of ART-123 on Subjects with Sepsis and Disseminated Intravascular Coagulation

Protocol Art-123

Multicenter, rAndomized, parallel Group Efficacy and safety study for prevention of venous thromboembolism in hospitalized medically iLL patients comparing rivaroxabAN with enoxaparin

Protocol BAY12839

/M2-111: Effect of Roflumilast on Exacerbation Rate in Patients with Chronic Obstructive Pulmonary Disease. A 52 Week Double-Blind Multicenter Study with 500mcg Roflumilast Once Daily Versus Placebo.

Protocol BY 217

12 Weeks Treatment with 250ug Roflumilast versus Placebo in Patients with Asthma.

Protocol BY217/FK1020

12 Weeks Treatment with 125ug Versus 250ug Versus Placebo in Patients with Asthma.

Protocol BY217/FK1021

Apixaban Versus Acetylsalicylic Acid (ASA) to Prevent Stroke inAtrial Fibrillation Patients Who Have Failed or are Unsuitable for Vitamin K Antagonist Treatment: A Randomized Double Blind Trial

Protocol CV185048

A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism

Protocol CV185056/7

A Phase 3, Randomized, Double-Blind, Evaluation of the Safety and Efficacy of Apixaban in Subjects with a Recent Acute Coronary Syndrome

Protocol CV185068

A Multi-center, Randomized, Open-Label, Phase 3 Study to Compare the Safety and Efficacy of Intravenous Doripenem in Complicated Lower Urinary Tract Infection or Pyelonephritis.

Protocol DORI-06

A Multicenter, Randomized, Open-Label, Phase 3 Study to Compare the Safety and Efficacy of Intravenous Doripenem with that of Meropenem in Complicated intra-Abdominal Infections.

Protocol DORI-07

A Multicenter, Randomized, Open-Label, Phase 3 Study to Compare the Safety and Efficacy of Intravenous Doripenem with that of Intravenous Piperacillin/Tazobactam in Hospital Acquired Pneumonia.

Protocol DORI-09

A Multicenter, Randomized, Open-Label, Phase 3 Study to Compare the Safety and Efficacy of Intravenous Doripenem with that of Intravenous Impenem in Ventilator Associated Pneumonia.

Protocol DORI-10

(Depression Response to Eszopiclone in Adults with Major Depressive Disorder): A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 8-Week, Safety and Efficacy Study of Eszopiclone 3 mg Compared to Placebo in Subjects with Insomnia Related to Major Depressive Disorder.

Protocol DREAMDD

The Pharmacokinetics of Drotrecogin Alfa (Activated) (Xigris™) in Patients > 160 kg with Severe Sepsis.

Protocol F1K-US-EVBS

A Phase III, Randomized, Double-Blind, Placebo-controlled Safety and Efficacy Study of Sitaxsentan Sodium Treatment with an Open-label Bosentan Arm in Patients with Pulmonary Arterial Hypertension- Encysive, L.P.

Protocol FPH02

A Long-Term, Open-Label Study to Evaluate the Long-Term Safety of Sitaxsentan Sodium Treatment with a Bosentan Arm in Patients with Pulmonary Arterial Hypertension- Encysive, L.P.

Protocol FPH02X

AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension (PAH)

Protocol GS-US-300-0140

BacLite Rapid MRSA Clinical Performance

Protocol I2MS 10737

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of a Single Infusion of MK-6072 (Human Monoclonal Antibody to C. Difficile Toxin B), and MK-3415A (Human Monoclonal Antibodies to C. Difficile Toxin A and B) in Patients Receiving Antibiotic Therapy for C. Difficile Infection (MODIFY II)

Protocol MK-3415A-002

An Open-Label, Multi-Center, Single Arm Study to Evaluate the Safety and Tolerability of Intravenous Zanamivir in the Treatment of Hospitalized Adult, Solescent and Pediatric Subjects with Confirmed Influenza Infection

Protocol NAI113678

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient Study to Assess the Long-Term Safety and Efficacy of Two Dose Levels of a Modified Release Formulation of NBI-34060 in Adult Patients with Primary Insomnia.

Protocol NBI-34060-MR-0211

A Phase III, Open-Label, Outpatient, Extension Study to Assess the Long-Term Safety of a Modified Release Formulation of NBI-34060 in Adult Primary Insomnia Patients with Sleep Maintenance Difficulties.

Protocol NBI-34060-MR-0220

A Pivotal, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-242 in Adults with Severe Sepsis.

Protocol No.01-04-TL-242-011

A Six-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Efficacy and Safety, Sleep Lab Trial with Org 50081 in Patients with Chronic Primary Insomnia.

Protocol Organon 176002

An Epidemiologic Study of Xolair® (Omalizumab)- Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (Q2948g)

Protocol Q294g

Phase III, Multicenter, Randomized, Placebo-Controlled, Double Blind, Three Arm Study to Evaluate the Safety and Efficacy of Tifacogin Administration in Subjects with Severe Community Acquired Pneumonia.

Protocol TFP008

A Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure TherapyTM in the Treatment and Blinded Evaluation of Pressure Ulcers.

Protocol VAC2001-01

A Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure TherapyTM in the Treatment and Blinded Evaluation of Venous Stasis Ulcers.

Protocol VAC2001-02

A Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure Therapy™ in the Treatment and Blinded Evaluation of Open Abdominal Wounds.

Protocol VAC2002-10

A Phase III, Randomized, Open-Label, Multicenter Study To Evaluate Safety And Efficacy of Dalbavancin Versus Vancomycin In The Treatment Of Skin and Soft Tissue Infections With Suspected Or Confirmed Methicillin Resistant Staphylococcus Aureus (MRSA).

Protocol VER001-16

A Single-Center, Pilot Study to Determine the Existence of a Relationship Between the Measurement of Skin Temperature Via the YSI Quicktemp Patch and the Measurement of Core Body Temperature Via an Oral Thermometer in Intensive Care Patients.

Protocol YSI-QT-08

Sources. ClinicalTrials.gov v2 API (facility-match + protocol-ID lookup against AIM's internal study list) and AIM Research's authoritative AIM Study List and Current Study Status documents (last updated March 21, 2017). Trial counts, phase, sponsor, dates, and status fields reflect the current record on ClinicalTrials.gov. Pre-registration protocols are documented via internal AIM study records.