Clinicaltrials report 2012 10.05.12.xls

South Alabama Medical Science Foundation
Clinical Trials (Projects over $2,000)
October 1, 2011 - September 30, 2012
| Project
Responsible
Source of
Dept | Number
Project Title
Receipts
College Of Medicine - Internal Medicine
The TRANSLATE-ACS Study: Treatment with ADP receptor
iNhibitorS: Longitudinal Assessment of Treatment Patterns and
Dr Beaver, B
Eli Lilly
3,051.00
Events after Acute Coronary Syndrome
A Phase III, Double-Blind, Randomized Placebo-Controlled Study to
Evaluate the Effects of RO4607381 on Cardiovascular (CV) Risk in
Dr Burckhartt, B
6,283.00
Stable CHD Patients with a Documented Recent Acute Coronary
Syndrome (ACS), Protocol No. NC20971
A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-
arm Trial to Determine Long-term Safety and Efficacy of Oral
Dr Culpepper, M
Otsuka Maryland Research Institute
34,745.00
Tolvaptan Tablet Regimens in Adult Subjects with Autosomal
Dominant Polycystic Kidney Disease
EVOLVE - Evaluation of Cinacalcet HCI Therapy to Lower
Dr Culpepper, M
7,369.00
Cardiovascular Events
Multi-center, Open-label, Extension Study to Evaluate the Long-term
Efficacy and Safety of Oral Tolvaptan Tablet Regimen in Subjects
Dr Culpepper, M
Otsuka Pharmaceutical
43,650.00
with Autosomal Dominant Polycystic Kidney Disease (ADPKD)
A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-
Blind, Placebo-masked, Parallel-group Pilot Trial to Compare the
Efficacy, Tolerability, and Safety of Tolvaptan Modified-release and
Dr Culpepper, M
Otsuka Pharmaceutical
15,188.00
Immediate-release Formulations, in Subjects with Autosomal
Dominant Polycystic Kidney Disease
A Multi-center, Longitudinal, Observational Study of Patients with
Autosomal Dominant Polycystic Kidney Disease (ADPKD) to
Dr Culpepper, M
Otsuka Pharmaceutical
2,000.00
Establish the Rate, Characteristics, and Determinants of Disease
Progression
A Randomized, Double-Blinded, Placebo-Controlled, Crossover,
Multicenter Phase III Safety Study of Soluble Ferric Pyrophosphate
Dr Culpepper, M
Rockwell Medical Technologies
20,681.00
SFP in Dialysate in Chronic Kidney Disease Patients Receiving
Chronic Hemodialysis
South Alabama Medical Science Foundation
Clinical Trials (Projects over $2,000)
October 1, 2011 - September 30, 2012
| Project
Responsible
Source of
Dept | Number
Project Title
Receipts
A Safety, Tolerance and Efficacy Evaluation of 3 Different Bowel
Cleansing Treatments in Adult Subjects, Including the Elderly and
Dr deMelo, S
Braintree Laboratories
58,350.00
Subjects with Hepatic or Renal Insufficiency
A Phase 2, Randomized, Double-Blind, Placebo-controlled,
Multicenter, Dose-ranging Study of Cicletanine in Subjects with
Dr Fagan, K
Gilead Sciences
7,616.00
Pulmonary Arterial Hypertension
A Randomized, Multicenter Study of First-Line Ambrisentan and
Tadalafil Combination Therapy in Subjects with Pulmonary Arterial
Dr Fagan, K
Gilead Sciences
6,125.00
Hypertension
A Postmarketing Observational Study to Assess Respiratory Tract
Adverse Events in Pulmonary Arterial Hypertension Patients
Dr Fagan, K
United Therapeutics Corporation
6,406.00
Treated with Tyvaso (treprostinil) Inhalation Solution
Drug Registry to PROSPECTively Describe Use of Room
Temperature Stable Epoprostenol for Injection in Patients with
Dr Fagan, K
Actelion Pharmaceuticals US, Inc.
6,500.00
Pulmonary Arterial Hypertension
Incidence of Secondary Iron Overload in Adults with Sickle Cell
Disease (SCD) Following Chronic, Intermitten Red Blood Cell (RBC)
Dr Haynes, J
Novartis Pharmaceuticals
29,559.00
Transfusions
A Phase III, Prospective, Randomized, Double-Blind, Placebo-
Controlled, Parallel-Group, Multicenter Study of L-Glutamine
Dr Haynes, J
Emmaus Medical
2,769.00
Therapy for Sickle Cell Anemia and Sickle B-Thalassemia
A Randomized, Placebo-controlled, Phase 2 Study of HQK-1001 in
Dr Haynes, J
HemaQuest Pharmaceuticals
12,500.00
Sickle Disease
Long-term Follow-up of Subjects in a Phase 1, 2, or 3 Clinical Trial
in Which Boceprevir or Narlaprevir was Administered for the
Dr Herrera, J
Schering Plough Research Institute
15,395.00
Treatment of Chronic Hepatitis C
South Alabama Medical Science Foundation
Clinical Trials (Projects over $2,000)
October 1, 2011 - September 30, 2012
| Project
Responsible
Source of
Dept | Number
Project Title
Receipts
A Phase 3 Safety and Efficacy Study of Erythropoietin Use During
Treatment of Subjects With Chronic Hepatitis C With Boceprevir,
Dr Herrera, J
Schering Plough Research Institute
7,103.00
Peginterferon Alpha-2b, and Ribavirin
A Randomized, Active-Controlled, Dose-Ranging Estimation Study
to Evaluate the Safety, Tolerability, and Efficacy of Different
Regimens of MK-5172 When Administered Concommitantly with
Dr Herrera, J
Merck & Co., Inc.
61,596.00
Peginterferon alfa-2b and Ribavirin in Treatment-Naïve Patients
with Chronic Genotype 1 Hepatitis C Virus Infection
A Phase 3 , Active (Warfarin) Controlled, Randomized, Double-
Blind, Parallel Arm Study to Evaluate the Efficacy and Safety of
Dr Massey, C
Bristol Myers-Squibb
6,655.00
Apixaban in Preventing Stroke and Systemic Embolism in Subjects
with Nonvalvular Atrial Fibrillation
A Multicenter, Randomized, Double-Blind, Placebo-Controlled
Cardiovascular Outcomes Study to Evaluate the Potential of
Aleglitazar to Reduce Cardiovascular Risk in Patients withe a Recent
Dr Omar, B
Hoffman-La Roche, Inc
5,475.00
Acute Coronary Syndrome (ACS) Event and Type 2 Diabetes
M llit
(T2D) #BC 22140
$ 359,016.
College Of Medicine - 'Emergency Medicine
An 8 Week, Randomized, Double-Blind, Parallel Group, Multi-
Center, Active Controlled Study to Evaluate the Antihypertensive
Efficacy and Safety of Aliskiren Administered in Combination with
Dr Pettyjohn, F
Novartis Pharmaceuticals
18,906.00
Valsartan versus Valsartan Alone in Patients with Stage 2 Systolic
Hypertension and Type 2 Diabetes Mellitus
Distribution of PCV13 Serotype Streptococcus Pneumoniae in Adults
50 Years and Older Presenting to Selected US Hospitals with Chest X-
Dr Pettyjohn, F
Wyeth Pharmaceuticals
2,889.00
Ray Confirmed Community-Acquired Pneumonia
A Multicenter, Multifactorial, Randomized, Double-Blind, Placebo-
Controlled Dose-Finding Study of Nifedipine GITS and Candesartan
Dr Pettyjohn, F
Bayer Healthcare Pharmaceuticals, Inc.
101,487.00
in Combination Compared to Monotherapy in Adult Patients with
Essential Hypertension
South Alabama Medical Science Foundation
Clinical Trials (Projects over $2,000)
October 1, 2011 - September 30, 2012
| Project
Responsible
Source of
Dept | Number
Project Title
Receipts
A Multicenter, Randomized, Double-Blind, Placebo-Controlled 8
Week Study to Evaluate the Safety and Efficacy of Nebivolol and
Dr Pettyjohn, F
Forest Research Institute
115,189.00
Valsartan Given as a Fixed-Dose Combination in Patients with Stage
1 or Stage 2 Essential Hypertension
Total Emergency Medicine
College Of Medicine - Surgery
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to
Investigate the Efficacy and Safety of Progesterone in Patients with
Dr Brevard, S
BHR Pharma LLC
4,500.00
Severe Traumatic Brain Injury
Vascular Endothelium Changes After Surgery
Dr Richards, WAmerican Society for Metabolic & Bariatric Surger
15,000.00
Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal
Dr Rider, P
Gore & Associates
11,200.00
and Coloanal Anastomoses
Total Surgery
College Of Medicine - Orthopaedic Surgery
Trial to Evaluate Ultrasound in the Treatment of Tibial Fractures
Dr. Alonso, J
McMaster University
9,713.00
South Alabama Medical Science Foundation
Clinical Trials (Projects over $2,000)
October 1, 2011 - September 30, 2012
| Project
Responsible
Source of
Dept | Number
Project Title
Receipts
Intranasal Ketorolac for Postoperative Pain after Total Knee and
Shoulder Arthoplasty: A Prospective Randomized Trial Evaluating
Dr Pearsall, A
Luitpold Pharmaceuticals
29,975.00
Safety and Efficacy
Total Orthopaedic Surgery
College Of Medicine - Neurology
A 24-Month Double-Blind, Randomized, Multicenter, Placebo-
Controlled, Parallel-Group Study Comparing the Efficacy and
Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered
Dr Bassam, B
Novartis Pharmaceuticals
25,487.00
Orally Once Daily Versus Placebo in Patients with Relapsing-
Remitting Multiple Sclerosis
Total Neurology
dicine - '
diatrics
A Multicenter, Prospective, Long-term, Observational Registry of
Dr Crissinger, K
Centocor, Inc.
41,025.00
Pediatric Patients with Inflammatory Bowel Disease
Role of Inhaled Nitric Oxide in Modifying the Effects of Mechanical
Ventilation with Supplemental Oxygen in Ureaplasma Exposed
Dr Eyal, F
12,000.00
Newborn Rats
An Open-label, Multicenter Study of the Safety of Twice Daily
Oxycodone Hydrochloride Controlled-release Tables in Opiod
Experienced Children from Ages 6 to 16 Years Old, Inclusive with
Dr Imran, H
Purdue Pharma
10,528.00
Moderate to Severe Malignant and/or Nonmalignant Pain Requiring
O i d A
An Observational Prospective Study to Assess the Outcomes and
Risk Factors of RSV Infection Among Premature Infants (32-35
Dr Savells, K
MedImmune, LLC
6,813.00
weeks Gestational Age)
Total Pediatrics
South Alabama Medical Science Foundation
Clinical Trials (Projects over $2,000)
October 1, 2011 - September 30, 2012
| Project
Responsible
Source of
Dept | Number
Project Title
Receipts
College Of Medicine - OBGYN
SQNM-T21-202/Noninvasive Screening for Fetal Aneuploidy: A New
Dr Baker, S
Sequenom
12,859.00
Maternal Plasma Marker
An Adaptive Multicentre, Randomized, Partially Double-Blind,
Placebo-Controlled Study to Assess the Safety, PK and PD/Efficacy
Dr Lewis, D
Novartis Pharmaceuticals
3,760.00
of RLX030 in Women with Pre-Eclampsia
A Double Blind, Randomized, Controlled, Multicenter, Proof of
Efficacy Study of Oral BGS649 vs. Placebo (Each Coadministered
Dr Rizk, B
Novartis Pharmaceuticals
24,379.00
with a Combined Oral Contraceptive) Assessing Pain Response in
Patients with Refractory Endometriosis
Total OBGYN
College Of Medicine - Cell Biology & Neuroscience
Effect of Hymovis/HYADD4-G on Viability and Function of Human
Wilson, G
Fidia Farmaceutici, S.p.A.
20,000.00
OA Chondrocytes
Total Cell Biology & Neuroscience
College Of Medicine - Physiology
NovelMed 9405: Myocardial Infarction/Ischemia Reperfusion Injury
Using Triphenyl Tetrazolium Chloride (TTC) in an Open Chest
Dr Cohen, M
NovelMed Therapeutics
8,000.00
Model with Rabbits
Total Physiology
South Alabama Medical Science Foundation
Clinical Trials (Projects over $2,000)
October 1, 2011 - September 30, 2012
| Project
Responsible
Source of
Dept | Number
Project Title
Receipts
College Of Medicine - Microbiology
Lion's/USA Eye Research
Dr Lausch, R
Lion'sClub
17,960.00
Microbiology
USA Mitchell Cancer Institute
An International Multi-Centre Open-Label 2-Arm Phase III Trial of
Dr Butler, T
Hoffmann-LaRoche
6,643.00
Adjuvant Bevacizumab in Triple Negative Breast Cancer
A Randomized Phase III, Double-Blind, Placebo-Controlled
Multicenter Trial of Everolimus in Combination with Trastuzumab
Dr Butler, T
Novartis Pharmaceuticals
19,303.00
and Paclitaxel, as First Line Therapy in Women with HER2 Positive
Locally Advanced or Metastatic Breast Cancer
An Open-Label, Randomized, Phase IIIb Trial Evaluating the
Efficacy and Safety of Standard of Care +/- Continuous
Bevacizumab Treatment Beyond Progression of Disease in Patients
Dr Cameron, D
Alpha Oncology
7,250.00
with Advanced Non-Squamous Non-Small Cell Lung Cancer
(NSCLC) after First-Line Treatment with Bevacizumab Plus a
Platinum Doublet-Containing Chemotherapy
A Phase I/II , Open-Label Study of Neratinib (HKI-272) in
Combination with Capecitabine in Subjects with Solid Tumors and
Dr Clarkson, D
Wyeth Research
108,006.00
ErbB-2 Positive Metastatic or Locally Advanced Breast Cancer
A Phase III Open Label, Randomized, 2 Arm Study of Ixabepilone
Administered Every 21 Days Versus Paclitaxel or Doxorubicin
Dr Finan, M
Bristol-Myers Squibb
8,272.00
Administered Every 21 Days in Women with Advanced Endometrial
Cancer Who Have Previously Been Treated with Chemotherapy
A Phase I/II Clinical Trial of the Hypomethylating Agent
Azacitadine (Vidaza) with the Nanoparticle Albumin Bound
Dr Khong, H
Abraxis/Celgene
81,125.00
Paclitaxel (Abraxane) in the Treatment of Patients with Advanced or
Metastatic Solid Tumors and Breast Cancer
South Alabama Medical Science Foundation
Clinical Trials (Projects over $2,000)
October 1, 2011 - September 30, 2012
| Project
Responsible
Source of
Dept | Number
Project Title
Receipts
Prospective Evaluation of Cyberknife Sterotactic Radiosurgery for
Low and Intermediate Risk Prostate Cancer: Emulating HDR
3,200.00
Brachytherapy Dosimetry
Phase IIb Study Evaluating the Safety and Efficacy of TXA127 in the
Reduction of Incidence and Severity of Thrombocytopenia in
Dr Reed, E
US Biotest
3,263.00
Patients Receiving Second-Line Combination of Gemcitabine and
Platinum Therapy for Recurrent Ovarian Carcinoma
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to
Evaluate the Efficacy and Safety of GS-6624 Combined with
Dr Reed, E
Gilead Sciences
2,000.00
Gemcitabine as First Line Treatment for Metastatic Pancreatic
Adenocarcinoma
A Non-Interventional Prospective Study of the Accuracy of the
Precision Therapeutics, Inc. ChemoResponse Assay in Patients with
Dr Rocconi, R
Precision Therapeutics, Inc.
16,000.00
Recurrent Epithelial Ovarian, Peritoneal, or Fallopian Tube Cancer
A Phase II, Open-Label, Single-Arm, Non-Randomized, Multi-
Center Study to Evaluate the Efficacy of Oral TKI258 as Second-
Dr Rocconi, R
Novartis Pharmaceuticals
5,750.00
Line Therapy in Patients with Either FGFR2 Mutated or Wild-Type
Advanced and/or Metastatic Endometrial Cancer
An International, Randomized, Double-Blind, Controlled Study of
Rindopepimut/GM-CSF with Adjuvant Temozolomide in Patients
Dr Russo, S
Celldex Therapeutics
6,000.00
with Newly Diagnozed, Surgically Resected, EGFRvIII-positive
Glioblastoma
An Open-Label Multicenter Phase II Study to Compare the Efficacy
and Safety of RAD001 as First-Line Followed by Second-Line
Sunitinib Versus Sunitib as First-Line Followed by Second-Line
Dr Taylor, W
Novartis Pharmaceuticals
70,260.00
RAD001 in the Treatment of Patients with Metastatic Renal Cell
C
A Phase III Study of Chemotherapy and Chemoradiotherapy With
or Without Hyperacute Pancreatic Cancer Vaccine in Subjects With
Dr Taylor, W
18,544.00
Surgically Resected Pancreatic Cancer
Total USAMCI
South Alabama Medical Science Foundation
Clinical Trials (Projects over $2,000)
October 1, 2011 - September 30, 2012
| Project
Responsible
Source of
Dept | Number
Project Title
Receipts
$ 206,302.00

Source: http://www.southalabama.edu/vpresearch/reports/2012/12ClinicalTrials.pdf