Below is a list of some of the clinical research done by our
investigators.
|
Client |
Study |
Protocol |
|
Abbot Laboratories |
The Depakot Choice Study, “Depakote- A Community-Based Study
Comparing the Overall Usefulness of DepakoteÒER vs.
DepakoteÒ Tablets in Subjects with New- Onset Partial
Seizure”. |
M02-549 |
|
Abbot Laboratories |
(ECLIPSE) “A
Compliance, Packaging, and Safety Assessment of Two
Packaging Formats and Dosing Regimens of GABITRILâ
(tiagabine hydrochloride) in Subjects with Partial Onset
Seizures” |
M00-190 |
|
Adolor |
A Phase 2,
Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging,
Parallel-Group Study of Alvimopan for the Prevention or
Reduction of Opioid-Induced Gastrointestinal Side Effects in
Subjects Undergoing Ambulatory Shoulder Surgery. |
17CL228 |
|
Almiral and Pfizer |
A Randomized,
Double-Blind, Placebo-Controlled Study of Oral Almotriptan
6.25 mg, 12.5 mg, and 25 mg in the Acute Treatment of
Migraine in Adolescents. |
638-CNS-0059-015 |
|
Aventis Pharmaceuticals, Inc. |
“A Multi-center,Double-blind, Open-label, Randomized,
Parallel Groups Study to Assess the Efficacy and Long-term
Safety Performance of Fexofenadine Compared to Montelukast
in Subjects with Asthma” |
M016455P/3001 & 3003 |
|
Aventis Pharmaceuticals, Inc. |
“A Phase III Double-blind, Double-dummy, Parallel-group,
Multicenter, Placebo-controlled, Efficacy and Safety Study
of Ciclesonide MDI 400 mg/day, 800 mg/day (Exactuator)
Administered Twice Daily for 12 Weeks in the Treatment of
Severe Persistent Asthma in Adolescents and Adults” |
XRP1526B-323/LT |
|
Aventis Pharmaceuticals, Inc. |
(TREAT) “A
Randomized, Open-Label, Multicenter Trial of the Safety and
Effectiveness of Oral Telithromycin (KetekÒ)
and Amoxicillin/Clavulanic Acid (AugmentinÒ)
in Outpatients with Respiratory Tract Infections in Usual
Care Settings. |
HMR3647A/3014-A |
|
Aventis Pharmaceuticals, Inc. |
“A Double-Blind, Randomized, Placebo and Active Controlled,
Parallel Group, Dose-finding Study to Evaluate the Efficacy
and Safety of One Daily Oral Administration of 5 mg, 10 mg,
25 mg, and 50 mg of M100240 for 8-Weeks in Subjects with
Mild-To-Moderate Essential Hypertension.” |
M100240-2004 |
|
Aztra Zenica |
A 52-week, randomised, double-blind, double-dummy,
parallel-group multicentre, Phase IIb study to evaluate the
effects of rosuvastatin 10mg, rosuvastatin 40mg and
atorvastatin 80 mg on urinary protein excretion in
hypercholesterolaemic diabetic
(PLANET II:non-diabetic) patients with moderate
proteinuria) |
|
|
Biocryst |
A Phase II,
Multicenter, Randomized, Double-Mask, Placebo-Controlled
Study to Evaluate the Efficacy and Safety of Intramuscular
Peramivir in Subjects with Uncomplicated Acute Influenza |
BCX1812-211 |
|
Biocryst |
“A Phase 3
Multicenter, Randomized, Double-Blind, Placebo-Controlled
Study to Evaluate the Efficacy and Safety of Intramuscular
Peramivir in Subjects with Uncomplicated Acute Influenza” |
BCX1812-311 |
|
BMS/Sanofi |
An International
Prospective Observational Registry in Subjects at Risk of
Atherothrombotic Events |
|
|
Boehringer Ingelheim Pharmaceuticals, Inc |
PRoFESS-Prevention Regimen For Effectively avoiding Second
Strokes: “A Double blinded, Active and Placebo Controlled
Study of AggrenoxÒ vs. Clopidogrel + Aspirin, With and
Without MicardisÒ”. |
9.159 |
|
Braintree |
BLI-AX-001 - A Double-Blind, Randomized, Parallel,
Multicenter Study of Axid (nizatidine) Oral Solution in the
Treatment of Gastroesophageal Reflux Disease (GERD) Symptoms
in Infants Age 30 Days - 1 Year |
|
|
Bristol Myers Squib |
A Multicenter,
Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial
to Evaluate the Safety and Efficacy of BMS-477118 as
Monotherapy in Subjects with Type 2 Diabetes Mellitus Who
Have Inadequate Glycemic Control. |
CV181008 |
|
Bristol Myers Squib |
OCTAVE “Omapatrilat Cardiovascular Treatment Assessment
Versus Enalapril.” |
CV137-120 |
|
Endo Pharmaceuticals |
“A Multiple-Dose, Non Randomized, Open-Label, Multicenter
Study to Evaluated the Long-Term Safety and Effectiveness of
EN3267 in the Treatment of Break through Pain in Cancer
Patients”. |
EN3267-007 |
|
Endo Pharmaceuticals |
“A Double-Blind,
Randomized, Placebo-Controlled, Multicenter Study to
Evaluate the Efficacy and Safety of EN3267 for the Treatment
of Breakthrough Pain in Opioid Tolerant Cancer Patients
Followed by an up to 12-Month Non-Randomized, Open-Label
Extension to Assess Long-Term Safety” |
EN3267-005 |
|
EXACT SCIENCES |
EXACT “A Multicenter Comparison of the EXACT Panel with
Hemoccult II for the Detection of Colorectal Neoplasia in
Average Risk Patients.” (The Colorectal Cancer Screening
Study). |
2001-01 |
|
Genaissance Pharmaceuticals |
STRENGTH I A
16-Week, Open-Label Investigation of Drug Response in
Relationship to Gene Variants (HAPÔ
MARKERS) In Adult Subjects With Primary Hypercholestrolemia” |
GNSC-003-01-HC |
|
Genaissance Pharmaceuticals. |
STRENGTH II A
16-Week, Open-Label Investigation of Drug Response to
Mevacorâ in
Gene Variants (HAPÔ
MARKERS) In Adult Subjects With Primary Hypercholestrolemia” |
GNSC-003-02-HC |
|
GILEAD |
A Phase 3
Randomized, Double-Blind, Placebo- and Active-Controlled,
Multi-center, Parallel Group Study to Evaluate the Safety
and Efficacy of Darusentan in Subjects with Resistant
Hypertension Receiving Combination Therapy with Three or
More Antihypertensive Drugs, Including a Diuretic, as
Compared to Guanfacine or Placebo Gilead Sciences, Inc. |
DAR-312 |
|
Glaxo Wellcome |
“A Twelve-Week Randomized, Double-Blind, Placebo-Controlled
Study of the Efficacy and Tolerability of Alosetron
Hydrochloride 1 mg Twice Daily for Control of Bowel Urgency
In Females with Non-Constipated Irritable Bowel Syndrome In
An Independent Practitioner Association (IPA) Model.” |
S3B40031 |
|
Glaxo Wellcome |
“A 24 Week Randomized, Open Label Study of Health Care
Resource Use, Quality of Life and Productivity With
Alosetron 1mg Twice Daily Versus Traditional Therapy in
Females With Non-constipated Irritable Bowel Syndrome” |
S3B30020 |
|
Glaxo Wellcome |
“A Randomized, Double-Blind, Double-Dummy,
Placebo-Controlled, Parallel Group Clinical Trial of Four
Weeks Treatment with SEREVENT Inhalation Aerosol, 25mcg BID,
50mcg BID and Placebo Administered Via a Valved Holding
Chamber with Facemask in Subjects with Asthma Age 24 to 47
Months.” |
SMS30076 |
|
Glaxo Wellcome |
A 16-week, Parallel-Group, Double-Blind, Randomized,
Placebo-Controlled, Multicenter, Dose-Ranging Study to
Evaluate the Efficacy, Safety and Tolerability of Multiple
Doses and Multiple treatment Regimens of GSK716155, with
Byetta as an Open-Label Active Reference, in Subjects with
Type 2 Diabetes Mellitus. |
GLP110125 |
|
Glaxo Wellcome |
“A Randomized,
Double-Blind, Parallel Group Comparison Study of Inhaled
Fluticasone Propionate (88mcgBID) Versus Montelukast Sodium
(10 mg QKD) in Subjects Currently receiving Beta Agonist
Alone” |
FLTA 4038 |
|
Glaxo Wellcome |
“A Randomized, Double-Blind, Double-Dummy, parallel Group,
Comparative Study of Inhaled Fluticasone Propionate 88 mcg
BID Versus Zafirlukast 20mg BID Asthmatic Subjects Who are
Currently Receiving Low Dose Inhaled Corticosteriods.” |
FLTA 4039 |
|
GlaxoSmithKline |
SUMMIT
“Identification of Migraine Headache Among Self-described
and/or Physician Diagnosed Sinus Headache Sufferers and
Treatment with ImitrexÒ
50mg Tablets.” |
SUM40294 |
|
KOS Pharmaceuticals, Inc. and DuPont Pharmaceuticals
Company. |
THE IMPACT STUDY “The Impact of Medical Subspecialty on
Patient Compliance to Treatment” |
MA-01-010401 |
|
Merck & Co., Inc. |
“A Randomized,
Placebo-Controlled, Parallel Group, Double-Blind Study to
Evaluate the Safety and Efficacy of Rofecoxib 12.5 mg,
Rofecoxib 25 mg, and Celecoxib 200 mg in Patients with
Osteoarthritis of the Knee or Hip” |
482 |
|
Merck & Co., Inc. |
“A Double-Blind, Placebo-Controlled, Parallel-Group, 12 Week
Trial to Assess the Efficacy and Safety of MK-0663 in
Patients with Chronic Low Back Pain” |
041-00/COX492 |
|
Neurocrine Biosciences, Inc |
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 |
NBI-34060-MR-0220 |
|
Novartis |
A 26-week treatment, multicenter, randomized, double-blind,
double dummy, placebo-controlled, adaptive, seamless,
parallel-group study to assess the efficacy, safety
and tolerability of two doses of indacaterol (
selected from 75, 150,300,& 600 ug o.d.) in patients with
chronic obstructive pulmonary disease using blinded
formoterol ( 12 ug b.i.d ) and open label tiotropium ( 18 ug
o.d.) as active controls |
CQAB149B2335S |
|
Novartis |
“To Assess the
Safety and Efficacy of Tegaserod 12 mg/d and Placebo in
Females with Constipation-Predominant Irritable Syndrome
C-ISB)” |
CHTF919 0358 |
|
Novartis |
“A Multicenter,
Double-Blind, Randomized, Parallel-Group, Dose-Ranging Study
to Assess the Efficacy, Safety and Tolerability of LAF237 25
mg BID, 25, 50 or 100 mg OD Compared to Placebo in Patients
with Type 2 Diabetes.” |
CLAF237A2203 |
|
Novartis |
“A 6 month, Randomized, Multi-Center, Parallel Group,
Double-Blind, Vehicle-Controlled Study to Evaluate the
Efficacy and Safety of ASM 981 (pimecrolimus) Cream 1% BID
vs. Standard of Care in the Management of Mild to Severe
Atopic Dermatitis in Children 3 Months to 11 Years”. |
CASM 981 US04 |
|
Novartis |
“A Randomized, Multicenter, Placebo-controlled Parallel
group Study of 4 Months Duration per Patient to Evaluate the
Safety and Efficacy of Treatment with 24 mg BID and 12 mg
BID Formoterol (Foradil), Double-blind and 12 mg Formoterol
(Foradil) with Additional On-demand Formoterol (Foradil)
Doses, Open-label, in Adolescent and Adult Patients with
Persistent Stable Asthma” |
CFOR258D 2307 |
|
Novartis |
NAVIGATOR “A
Randomized, Double-Blind, Placebo-Controlled, Multi-Center
Study of the
Efficacy and Safety of Long Term Administration of
Nateglinide and Valsartan in the Prevention of Diabetes and
Cardiovascular Outcomes in Subjects with Impaired Glucose
Tolerance (IGT).” |
CDJN608B2302 |
|
Otsuka Pharmaceuticals America, Inc. |
“A randomized,
Double Blind, Placebo Controlled, Multicenter, Parallel-Arm
Study to Assess the Long-Term Effects of Pletalâ
(Clistazol) Versus Placebo Administered Orally to Patients
With Intermittent Claudication Secondary to Peripheral
Arterial Disease.” |
21-98-214-01 |
|
Pharmacia |
SUCCESS II “Clinical Protocol for a Multicenter,
Double-Blind, Placebo-Controlled, Randomized, Parallel Group
Study in the U.S. to Compare the Efficacy and Tolerability
of Valdecoxib Vs. Tramadol in Treatment of Acute Ankle
Sprains” |
872-IFL-0513-008 |
|
Pharmacia |
“A Multicenter,
Double-Blind, Placebo-Controlled, Randomized, Parallel Group
Study in The U.S. to Compare The Efficacy and Tolerability
of Celecoxib VS. Ibuprofen in Ankle Sprain. (Success-IIA)” |
N49-99-02-127 |
|
Sanofi-Synthelabo |
Prospective,
Observational Registry and Patient Survey of the Management
of Men with Benign Prostatic Hyperplasia (BPH). |
L8890 |
|
Sanofi-Synthelabo |
Prospective, Observational Registry and Patient Survey of
the Management of Men with Symptomatic Benign Prostatic
Hyperplasia (BPH) BPH Registry and Patient Survey |
L8890 |
|
Sanofi-Synthelabo/BMS |
An international
prospective observational registry in subjects at risk of
atherothrombotic events. REACH study |
C8903 |
|
Savient Protocol N: C0603 |
“A randomized,
double-blind, placebo-controlled, multicenter, dose ranging
study to evaluate the efficacy and safety of prosaptide over
6 weeks of treatment for the relief of neuropathic pain
associated with HIV-1”. NARC |
009 / BTGC |
|
Searle |
“A Multi-Center, Randomized, Double-Blind,
Placebo-Controlled, Parallel Group Trial Involving 350
Patients With Mild To Moderate Hypertension To Evaluate the
Efficacy and Safety of Ranging Doses of Eplerenone.” |
IE3-99-02-049 |
|
Searle |
“A Double-Blind Randomized, Active-Controlled Comparison
Study of the Antihypertensive, Renal, and Metabolic Effects
of Eplerenone Versus Enalapril in Patients with Type 2
Diabetes Mellitus, Albuminuria, and Hypertension.” |
IE3-99-02-021 |
|
Senju Pharmaceutical Co, Ltd. |
A Phase III
Multicenter, Randomized, Double Masked, Parallel Study to
Compare the Safety and Efficacy of 0.3% Gatifloxacin
Ophthalmic Solution With That of Placebo in the Treatment of
Acute Bacterial Conjunctivitis. |
SPCL-GFLX 3/0.1 |
|
Solvay Pharmaceuticals, Inc |
A Double-Blind,
Placebo-Controlled, Randomized, Multicenter Study to
Investigate the Efficacy and Safety of Cilansetron in
Non-Constipated Patients with Established Irritable Bowel
Syndrome. |
S2413001 |
|
Solvay Pharmaceuticals, Inc |
A Double-Blind,
Randomized, Parallel-Group, Pilot Study of Oral Dronabinol
versus Placebo in the Treatment or Prevention of Highly
Active Antiretroviral Therapy (HAART)-related Nausea and
Vomiting. |
S1752101 |
|
Solvay Pharmaceuticals, Inc |
A Double-Blind,
Randomized, Placebo-Controlled, Parallel Study to Evaluate
the Efficacy and Safety of AndroGel, as an Adjunct to Oral
Hypoglycemic Therapy, in the Treatment of Hypogonadal Men
with Type 2 Diabetes. |
S1756101 |
|
Solvay Pharmaceuticals, Inc |
“A Double Blind, Placebo-Controlled, Randomized, Multicenter
Study to Investigate the Safety and Efficacy of Cilansetron
in Non-Constipated Patients with Established Irritable Bowel
Syndrome.” |
S2413002 |
|
Solvay Pharmaceuticals, Inc |
“A Double-blind, Placebo-controlled, Randomized, Multicenter
Study to Investigate the Safety and Efficacy of 2 mg TID of
Cilansetron Over 12 Weeks in Diarrhea-predominant Irritable
Bowel Syndrome Subjects” |
S2413006 |
|
Solvay Pharmaceuticals, Inc |
A Double-Blind,
Randomized, Placebo-Controlled, Parallel Study to Evaluate
the Efficacy and Safety of AndroGel®, as an Adjunct to Oral
Hypoglycemic Therapy, in the Treatment of Hypogonadal and
Low Testosterone Men with Type 2 Diabetes |
S1762101 |
|
Takeda Pharmaceuticals America, Inc |
A Long-Term,
Open-Label Extension Study to Investigate the Long-Term
Safety of SYR110322 (SYR-322) in Subjects with Type 2
Diabetes |
SYR-322-OLE-012 |
|
Takeda Pharmaceuticals America, Inc |
A Multicenter,
Double-Blind Study to Determine the Efficacy and Safety of
SYR-322 plus Pioglitazone HCl (Actos®), SYR-322 Alone or
Pioglitazone HCl Alone in Subjects with Type 2 Diabetes |
01-06-TL-322OPI-002 |
|
Takeda Pharmaceuticals America, Inc |
“A Randomized Comparator, Controlled, Double Blind Study Of
the Liver Safety of Pioglitazone HCl Versus Glyburide With
Metformin and Insulin as Part of Step Therapy in Subjects
With Type 2 (Non-Insulin Dependent) Diabetes” |
01-00-TL-OPI-506 |
|
Takeda Pharmaceuticals America, Inc. |
A Randomized
Comparator, Controlled, Double Blind Study of Liver Safety
of Pioglitazone HCl Versus Glyburide With Metformin and
Insulin as Part of Step Therapy in Subjects With Type 2
(Non-Insulin Dependent) Diabetes |
01-00-TL-OPI-506 |
|
UCB |
A Phase IIb
multi-center, double-blind, placebocontrolled, randomized
trial to examine the corticosteroid-sparing effect of
certolizumab pegol in patients with moderate to severe
Crohn's disease (COSPAR I) |
C87059 |
|
Wyeth-Ayerst |
“An Open-Label, Randomized, Rater-Blinded Study To Compare
Rate Of Remission in Patients with Major Depressive Disorder
Treated With Venlafaxine Extended-Release Versus Selective
Serotonin Reuptake Inhibitors Using Treatment Algorithms” |
0600B-100470 |
|
|
“Efficacy and Safety of RWJ-241947 Monotherapy In Type 2
Diabetic Subjects; A 52-Week Double Blind, Randomized,
Active-Controlled Study with a 26-Week Uncontrolled
Extension.” |
241947-DIAB-006 |
|
|
“Safety and Efficacy of Pentavalent (G1, G2, G3, G4, and P1)
Human-Bovine -Reassortant Rotavirus Vaccine in Healthy
Infants.” |
V260-006 |
|
|
A Comparison of
Prasugrel and Clopidogrel in Acute Coronary Syndrome (ACS)
Subjects with Unstable Angina/Non-ST-Elevation Myocardial
Infarction (UA/NSTEMI) Who are Medically Managed – The
TRILOGY ACS Study Elli Lilly |
H7T-MC-TABY |
|
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