Abbott Laboratories
Protocol 2001- 007: A Safety Trial Using Recombinant Urokinase (ABT-120,
urokinase alpha) in the Treatment of Occluded Central Venous Catheters
Abbott Laboratories
Protocol 95028: A twelve to twenty-eight week comparison between 19-nor-1
alphy, 25-dihydroxyvitamin D2 and intravenous Calcitriol (Zemplar study)
Abbott Laboratories
Protocol 96004: Open study of the long-term treatment of end stage renal
disease in patients undergoing hemodialysis with 19-nor-1 alpha, 25dihydroxyvitaminD2-New Patients (zemplar study)
Abbott Laboratories
Protocol P02134: Long Term, Open-Label, Safety and Tolerability Study of
SCH 58235 in Addition to Simvastatin in Patients With primary
Hypercholesterolemia Who Have Previously Completed the 12-Week DoubleBlind Study (Protocol Nos. P00679 and P00680)
American Regent
Laboratories, Inc.
A Double-Blind, Randomized, Two Group, Parallel Study Comparing the FirstDose Safety of Dexferrum and Infed Administered Intravenously to End Stage
Renal Disease Patients Requiring Iron Replacement Therapy
Amgen, Inc.
Protocol 20000188: A Placebo-Controlled, Double-Blind, Multicenter Study to
Assess the Efficacy and Safety of an Oral Calcimimetic Agent (AMG 073) in
Secondary Hyperparathyroidism of Chronic Kidney Disease (Hemodialysis and
Peritoneal Dialysis)
AstraZeneca
Pharmaceuticals,
L.P.
Protocol 237: A Randomized, Double-Blind, Comparative Study of H376/95
and Enoxaparin for the Prevention of Venous Thromboembolism Following
Total Hip Arthroplasty
AstraZeneca
Pharmaceuticals,
L.P.
Protocol 223 (SH-TPV-0005): A Double Blind, Efficacy and Safety of the Oral
Direct Thrombin Inhibitor, H376/95, versus Standard Therapy (Enoxaparin and
Warfarin) in Patients with Acute, Symptomatic Deep Venous Thrombosis with
or without Pulmonary Embolism (THRIVE V)
AstraZeneca
Pharmaceuticals,
L.P.
Protocol 233 (SH-TPA-0005): Efficacy and Safety Study of the Oral Direct
Thrombin Inhibitor H376/95 Compared with Dose-Adjusted Warfarin
(Coumadin) in the Prevention of Stroke and Systemic Embolic Events in
Patients with Atrial Fibrillation (SPORTIF V)
AstraZeneca
Pharmaceuticals,
L.P.
Prospective Study of Venous Thromboembolism (VTE) Patient Characteristics,
Diagnostic Methods, and Treatment Plans in Preparation for a Phase III Study
Aventis
Pharmaceuticals,
Inc.
Protocol DVT 01-01: An Epidemiological Observational Study of Deep Vein
Thrombosis (DVT)
Aventis
Pharmaceuticals,
Inc.
Protocol XRP 4563C/3501: A Double-Blind, Placebo-Controlled, Parallel,
Multicenter Study on Extended VTE Prophylaxis in Acutely Ill Medical Patients
with Prolonged Immobilization
Bayer Corporation
Protocol 100272: A Prospective, Randomized, Double-Blind, Multicenter Trial
Assessing the Safety and Efficacy of Sequential (Intravenous/Oral) BAY 128039 (Moxifloxacin) 400mg Every 24 Hours Compared to Intravenous
Piperacillin/Tazobactam 3.375g Every 6 Hours Followed by Oral
Amoxacillin/Clavulanic Acid Suspension 800mg Every 12 Hours for the
Treatment of Patients with Complicated Intra-Abdominal Infections
Bayer Corporation
Protocol 587-9201: Prospective, Double-Blind, Placebo-Controlled,
Randomized, Multicenter North American Study of the Safety and Efficacy of
Murine Monoclonal Antibody to Tumor Necrosis Factor (TNF Mab) for the
Treatment of Patients with Septic Shock
Bristol-Meyers
Protocol CV137-009: Open-Label, Long-Term study of the Antihypertensive
Squibb
Activity and Safety of BMS-186716, A Dual Metalloprotease Inhibitor, in the
Treatment of Hypertension
Bristol-Meyers
Squibb
Protocol CV137-120: Omapatrilat Cardiovascular Treatment Assessment
Versus Enalapril (OCTAVE)
DuPont
Pharmaceuticals
Company
Protocol DMP 702-401: A Phase IV, Multicenter, Prospective, Open-Label,
Observational Study to Evaluate Clinical Practice Patterns of Innohep
(Tinxaparin sodium injection) in the Treatment of Acute Symptomatic Deep
Venous Thrombosis
Eli Lilly and
Company
Protocol H6W-MC-MCAA: A Phase 2 Study to Determine the Efficacy and
Safety of Sivelestat in Subjects with Acute Lung Injury
Eli Lilly and
Company
Protocol H4Q-MC-ARRD: LY333328 versus Vancomycin in Skin/SkinStructure Infections
Eli Lilly and
Company
Protocol F1D-US-HGJU: A Controlled Trial of Olanzapine versus Ziprasidone
in the Treatment of Schizophrenic and Schizoaffective Subjects with Comorbid
Depression
Eli Lilly Research
Laboratories
Protocol F1K-MC-EVAD: A Phase III Study to Determine the Efficacy and
Safety for Recombinant Human-Activated Protein C in Severe Sepsis
Endo
Pharmaceuticals
Protocol EN3202.021: An Open-Label Extension Study to Evaluate the LongTerm Safety, Tolerability and Analgesic Efficacy of Numorphan CR
(oxymorphone HCl controlled release) in Subjects with Cancer Pain or Chronic
Lower Back Pain
Endo
Pharmaceuticals
Protocol EN3202.019: A Randomized, Double-Blind, Two-Period Crossover
Study Comparing the Efficacy, Safety and Tolerability of Numorphan CR
(Oxymorphone HCl, Controlled Release) and OxyContin (Oxycodone HCl,
Controlled release) in Cancer Patients who Require Chronic Opioid
Treatments
GlaxoSmithKline
Protocol SB265805/287: An Open Label, Non-Comparative Study to Assess
the Efficacy and Safety of Oral Gemifloxacin 320mg, Once Daily for Seven
Days, for the Treatment of Community-Aquired Pneumonia of Suspected
Pneumoncoccal Origin in Countries with a High Prevalence of Drug-Resistant
Respiratory Pathogens
GlaxoSmithKline
Protocol 208127/091: A phase 4, open, randomized, controlled, comparative,
multicenter U.S. study of the safety of GlaxoSmithKline Biologicals'
combination hepatitis A and hepatitis B vaccine (Twinrix®: 720 EL.U of
hepatitis A antigen and 20 mcg of hepatitis B surface antigen per mL)
administered on a 0, 1, 6 month schedule by intra-muscular injection
compared with concurrently administered monovalent vaccines (Havrix®: 1440
EL.U/mL on a 0, 6 month schedule and Engerix-B®: 20 mcg/mL on a 0, 1, 6
month schedule) in healthy adults 18 years of age and older
GlaxoSmithKline
Protocol: 49653/183: A 24-Week Randomized, Double-blind, Double-dummy,
Multicenter Study to Evaluate the Safety, Efficacy, and Tolerability of Modified
Release Avandia® (8mg OD) and Immediate-Release Avandia® (4mg BD) in
Patients with Type 2 Diabetes Mellitus
GlaxoSmithKline
Protocol BRL 49653/330: A Randomized, Double Blind, Placebo Controlled,
Parallel Group Study to Assess the Safety and Efficacy of Three Dose Levels
of Rosiglitazone Maleate in the Treatment of Chronic Plaque Psoriasis
GlaxoWellcome
Protocol S3B300020: 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
Hennepin County
Medical Center
A randomized trial comparing cyclosporine with cyclophosphajide plus
prednisone in the treatment of progressive membranous glomerulonephritis
Hoechst Marion
Roussel
Protocol HMR 3647A/3009: A Double-Blind, Multicenter, Randomized, ActiveControlled, Two-Arm Parallel-Group Comparative Study of the Efficacy and
Safety of Oral HMR 3647(800mg once daily) for 7 to 10 Days versus Oral
Trovafloxacin 9200 mg once daily) for 7 to 10 days in the Treatment of
Community-Acquired Pneumonia in Adults
Hoescht
Protocol #403: A multicenter, randomized evaluator blind, comparative study of
the efficacy of cefotaxime sodium (Claforan) in the treatment of loser
respiratory tract infections with q12h and q8h dosing regimens
Hoffman La-Roche
Ltd.
Protocol MF-4411: Multicenter, Double-Blind, Placebo-Controlled, Randomized
Study on the Efficacy and Safety of Ibandronate During Three Years'
Treatment in Patients with Post-Menopausal Osteoporosis and Vertebral
Fractures using a Continuous Oral (2.5mg daily) and an Intermittent Oral
(20mg every 2nd day for 24 days every 3 months) Dosing Regimen
Johnson & Johnson
Pharmaceutical
Protocol RIS-USA-232: Efficacy and Safety of a Flexible Dose of Risperidone
Versus Placebo in the Treatment of Psychosis in Alzheimer's Disease
Knoll
Pharmaceutical
Company
Protocol DO-109: Safety and Tolerability of Long-Term Administration of
Dilaudid SR (Hydromorphone HCl)
Knoll
Pharmaceutical
Company
Protocol DO-104: A Repeated-Dose Evaluation of Analgesic Use and Safety of
Dilaudid SR (Hydromorphone HCl) in Patients with Chronic Cancer Pain
Knoll
Pharmaceutical
Company
Protocol DO-105: A Repeated-Dose Evaluation of Analgesic Use and Safety of
Dilaudid SR (Hydromorphone HCl) in Patients with Chronic Non-Malignant
Pain
Merck & Company
Protocol MK-793A: A Randomized, Placebo-controlled, double-blind, parallel
study comparing the antihypertensive efficacy and safety of diltiazem extended
release (ER)(MODS-A 12 hour formulation) monotherapy, enalapril
monotherapy and the combination of diltiazem ER and enalapril in patients
with mild to moderate hypertension
Merck & Company
Protocol MK-218A: A Randomized, Double-blind, placebo-controlled,
Multicenter study of the safety and antihypertensive efficacy of concomitant
treatment with felodipine ER and enalapril in patients with mild to moderate
essential hypertension
Merck
Protocol 037-01/ERT516: A Prospective, Multicenter, Double-Blind With InHouse 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
Merck-Schering
Plough
Protocol P02134: Long-Term, Open-Label, Safety and Tolerability Study of
SSCH 58235 in Addition to Simvastatin in Patients with Primary
Hypercholesterolemia Who Have Previously Completed the 12-Week DoubleBlind Study (Protocol Nos. P00679 or P00680)
National Heart,
Lung, and Blood
Institute
The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack
Trial
Novartis
RE: Protocol CSPP100A2201: A multicenter, randomized, double-blind,
placebo-controlled, parallel- group study comparing aliskiren 150 mg, 300 mg,
and 600 mg to placebo and irbesartan 150 mg in patients with mild-to-
moderate essential hypertension
Novartis
Protocol CSPP100A2203: A randomized, double-blind, multicenter,
multifactorial, placebo-controlled, parallel-group study to confirm the efficacy
and safety of aliskiren monotherapy, and evaluate efficacy and safety of
combinations of aliskiren and valsartan in hypertensive patients
Novartis
Protocol CCOX189A2360: A 13-week, multicenter, randomized, double-blind,
double-dummy, placebo-controlled, parallel trial of 2 different dose regimens of
lumiracoxib (100 mg od and 200 mg od initial dose for two weeks followed by
100 mg od) in patients with primary knee osteoarthritis, using celecoxib (200
mg od) as a comparator
Novartis
Protocol CCOX189A2360E1: A 39-week, open-label extension to
CCOX189A2360, a 13-week, multicenter, randomized, double-blind, doubledummy, placebo-controlled, parallel trial of 2 different dose regimens of
lumiracoxib (100 mg od and 200 mg od initial dose for two weeks followed by
100 mg od) in patients with primary knee osteoarthritis, using celecoxib (200
mg od) as a comparator
NPS Allelix
Corporation
Protocol ALX1-11-93001: An 18-Month Double-Blind, Placebo-Controlled,
Phase III, Trial with a 12-Month Interim Analysis of the Effect of Recombinant
Human Parathyroid Hormone (ALX1-11) on Fracture Incidence in Women with
Postmenopausal Osteoporosis
Protocol LOFBIV-PNOP-001: A Multicenter, Randomized, Open Label Study to
Ortho-McNeil
Compare the Safety and Efficacy of Levofloxacin with that of
Pharmaceutical, Inc.
Imipenem/Cilastatin in the Treatment of Nosocomial Pneumonia
Pfizer, Inc.
Protocol A1281052: A Phase III, Randomized, Placebo-Controlled, DoubleDummy Study Evaluating the Safety and Efficacy of Oral Ziprasidone vs.
Haloperidol and Placebo in In-Patients with an Acute Manic Episode
Protocol M/1260/0054: Linezolid for the Treatment of Vancomycin-Resistant
Pharmacia & Upjohn
Enterococcal Infections: A Double Blind Trial Comparing 600mg Linezolid
Inc.
Every 12 Hours with 200mg Linezolid Every 12 Hours.
Protocol M/1260/0033: Linezolid (PNU-100766) in the treatment of
streptococcus pneumoniae pneumonia: an open-label study of intravenously
Pharmacia & Upjohn
administered linezolid with oral continuation compared with intravenously
Inc.
administered ceftriaxone sodium followed by orally administered cefpodoxime
proxetil
Rhone-Poulene
Rorer
Pharmaceuticals,
Inc.
Protocol JRV 397: Open Study of Synercid (Quinpristin/Dalfopristin, RP 59500)
for Emergency Use (Infections Due to Resistant Bacteria, Treatment Failure or
in Treatment-Intolerant Patients) EMERGENCY USE
Schering-Plough
Corporation
Protocol P01416: Long Term, Open-Label, Safety and Tolerability Study of
SCH 58235 in Addition to Pravastatin in Patients with Primary
Hypercholesterolemia
Scios Nova
Protocol # 702.315: A Randomized, Double-blind, placebo-controlled,
Multicenter, phase III clinical trial to evaluate the safety and efficacy of
auriculin anaritide in the treatment of oliguric acute tubular necrosis
Protocol 4910F/149: A Double-Blind, Randomized, Placebo-Controlled Study
SmithKline Beecham to Assess the Efficacy and Safety of Mupirocin Calcium Nasal Spray, 5% for
the Prevention of Recurrent Acute Bacterial Sinusitis
Protocol SB278817/003: Cervastatin for Hyperlipidemia After Reaching
Menopause (CHARM): A Randomized, Double Blind, Placebo-controlled
Parallel Group, 6-Week Evaluation of Cerivastatin 0.4mg and Atorvastatin
SmithKline Beecham
10mg in Post-Menopausal Women with Hyperlipidemia and a 46-Week
Evaluation in Which Cerivastatin 0.4mg is Compared to Fenofibrate 201 mg for
Long-Term Lipid-Lowering and Bone Mineral Density Effects
Protocol BRL46394A/Granisetron/513: A Double Blind, Multicenter, Parallel
Study Comparing the Efficacy and Safety of Kytril Tablets with Placebo, in the
SmithKline Beecham Prevention of Nausea and Vomiting During the Days Following Administration
of IV Cyclophosphamide-Based or Carboplatin-Based Chemotherapy in
Patients with Malignant Disease
Takeda
Pharmaceuticals
North America
Protocol 01-02-TL-375-032: A Phase III Safety Study to Evaluate the LongTerm Effects on Endocrine Function in Adult Subjects with Chronic Insomnia
Vasomedical, Inc.
The International EECP Patient Registry
Yamanouchi USA,
Inc.
Protocol 1025-007: A 4-day, Double-blind, Placebo-Controlled, Multicenter
Study of IV YM087 (CI-1025) to Assess Efficacy and Safety in Patients With
Euvolemic or Hypervolemic Hyponatremia
Yamanouchi USA,
Inc.
Protocol 1025-011: A 12-Week, Open-Label Extension to Protocol 1025-006
and Protocol 1025-007 to Evaluate the Safety and Efficacy of YM087 (CI-1025
in Patients with Euvolemic or Hypervolemic Hyponatremia