|
| |
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
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 Esophagitis.
|
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.
|
Infectious Disease
Herpes
|
A
Randomized, Double-Blind, Placebo Controlled, Efficacy and Safety Study of
an Investigational Drug in
|
Patients
with Recurrent Genital Herpes
c UTI
|
Comparison
between Oral XXXX 320mg qd vs oral XXXX 250mg qd for 10 days in treatment of
|
pyelonephritis
or complicated urinary tract infection.
UTI
|
An
Open Label, Multi-Center Trial Designed to Evaluate the Efficacy and Safety
of XXXX in the Treatment of
|
Simple
UTI
Internal Medicine
BPH
|
A
Multi-Center, Age Stratified, Double-Blind, Placebo-Controlled, Parallel
Group Dose Range Finding Study to
|
Evaluate
the Safety and Efficacy of a Fixed Dose Regimen of XXXX in Men with lower
Urinary Tract
Symptoms.
Dyslipidemia
|
A
Long-Term, Open- Label, Multi- Center Trial of the Safety and Efficacy of
XXXX in patients with
|
Dyslipidemia.
Herpes Zoster
|
Dose
Selection Study Using XXXX Varicella/Zoster Vaccine in Healthy Adults and in
Adults With Diabetes
|
Mellitus
or Chronic Obstructive Pulmonary Disease 60 Years of Age and Older With a
History of Varicella.
Hypercholesterolemia
|
A
Multi-Center, Randomized, Parallel, Open-Label, Actual Use Study With XXXX
To Assess Consumer
|
Behavior,
Compliance and Safety in a Simulated OTC-Like and RX-Like Population
Hypertension
|
Evaluation
of the Efficacy and Tolerability of XXXX in Hypertensive Patients Across
Several Aspects of
|
Patient
Demographics.
|
A
Prospective, Multinational, Multicenter, Double- Blind, Randomized , Active-
Controlled Trial in patients with
|
Essential
Hypertension to Compare the Effect of XXXX 80 and 160 mg, with or without the
Addition of
Hydrochlorothiazide,
Once Daily.
|
XXXX
Cardiovascular Treatment Assessment Versus Enalapril (XXXX).
|
PAIN
|
Assessment
of Safety and Tolerability of Oral Sustained Release XXX vs. Oral Immediate
Release XXX in
|
Patients
with Chronic Non-Malignant Pain
Persistent back pain
|
Open
Label, Randomized, 3 Month Study in Persistent Back Pain Comparing Oxycontin
vs Hydrocodone/APAP
|
Neurology
Migraine Headache
|
A
Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to
Evaluate the Efficacy of XXXX for
|
the
Treatment of Migraine Subjects Who Do Not Respond to Oral Sumatriptan.
Pain
|
Safety
and Tolerability of Long-Term Administration of XXXX.
|
A
Repeated-Dose Evaluation of Analgesic Use and Safety of XXXX in Patients with
Chronic Cancer Pain.
|
A
Repeated-Dose Evaluation of Analgesic Use and Safety of XXXX in Patients
With Chronic Non-Malignant
|
Pain.
|
Morphine
With XXXX: Conversion From Other Opioid Analgesics |
|
An
evaluation of the effect of titration schedules of XXXX in subjects with
Chronic Pain.
|
OB_Gyn
Endometriosis
|
A
Randomized, Multi- Center, Open- Label, Dose- Ranging Study Comparing the
Safety and Efficacy of XXXX
|
to
Lupron Depot 3.75 mg in Women with Endometriosis- Associated Pain. Phase B
|
A
Randomized, Multi- Center, Open- Label, Dose- Ranging Study Comparing the
Safety and Efficacy of XXXX
|
to
Lupron Depot 3.75 mg in Women with Endometriosis- Associated Pain. Phase A
Incontinence
|
Clinical
Trial with XXXX for the Long Term Treatment of Stress Urinary Incontinence
in Women. |
|
Comparison
of Dry Mouth During Treatment with XXXX and Ditropan in Patients With Urge
Urinary
|
Incontinence.
Pulmonology
|
A
follow-up, Pilot Study of the Infection-Free Interval Following Treatment of
Acute Exacerbation of Chronic Bronchitis. |
|
A
Randomized, Double-Blind, Multicenter, Comparative Study of an
XXXXInvestigational Drug versus Cefuroxime
|
Axetil
in the treatment of Acute Exacerbation of Chronic Bronchitis
COPD
|
An
Open-Label, Long-Term Study of the Safety and Tolerability of XXXX in
Patients with Moderate to Severe
|
COPD
|
Safety
and Efficacy of XXXX in Patients with Moderate to Severe COPD |
|
Efficacy
and safety of XXXX-DPI in patients with Chronic Obstructive Pulmonary
Disease (COPD).
|
Pediatric Asthma
|
A
One Year, Open Label Safety Study of XXXX and XXXX in Children with Asthma
Previously on Inhaled
|
Corticosteroids.
|
One-
Year, Open Label Study of XXXX and XXXX in Children with Asthma Previously
Maintained on Inhaled
|
Corticosteroids.
Rheumatology
Arthritis
|
A
Clinical Protocol for a Multicenter, Double-Blind, Parallel Group Study
Comparing the Incidence of Clinically
|
Significant
Upper Gastrointestinal Adverse Events Associated with XXXX 400 mg BID to That of
NSAID
|
An
Open-Label, Long-Term Study of the Safety and Tolerability of Oral
Investigational Drug in Rheumatoid
|
Arthritis
Patients.
|
Clinical
Protocol to Evaluate the Long-Term Safety of XXXX in Treating the Signs and
Symptoms of
|
Osteoarthritis
and Rheumatoid Arthritis.
|
A
Multiple Dose-Response Study of XXXX in Rheumatoid Arthritis Patients. |
|
The
evaluation of the long-term safety of XXXX in
treating the signs and symptoms for Osteoarthritis and
|
rheumatoid
arthritis
|
Multicenter,
Double-Blind, Parallel Group Study Comparing the Incidence of Gastroduodenal
Ulcer Associated
|
with
XXXX 200mg BID with that of Diclofenac 75mg BID and Ibuprofen 800mg TID, Taken
for 12 Weeks in
Patients
with OA/RA.
Urology
BPH
|
A
Phase II/III, Double-Blind, Placebo-Controlled, Dose-Finding Study of the
Safety and Efficacy of XXXX in
|
Patients
with Symptomatic Benign Prostatic Hyperplasia (BPH).
|
An
Eleven- Week, Open- Label, Randomized, Multicenter, Parallel-Design, Placebo
Lead-in Study of XXXX
|
Capsules,
0.4 mg Daily Versus HYTRIN Capsules, 5 mg Daily in Patients with the Signs and
Symptoms of
Benign
Prostatic Hyperplasia.
|
A
Randomized, Double-Blinded, Placebo- Controlled, Parallel- group study of
the efficacy and safety of XXXX
|
In
the treatment and modification of progression of benign Prostatic Hyperplasia.
|
A
Randomized, Double-Blind, Placebo-Controlled, Two-Year Parallel Group Study
of the Efficacy and Safety
|
of
XXXX 0.5 mg in the Treatment and Prevention of Progression of Benign Prostatic
Hyperplasia.
|
An
Open Label Extension of XXXX a Five Alpha Reductase Inhibitor for the
Treatment of BPH.
|
A
Double -Blind, Placebo Controlled, multi-Site Trial of XXXX a Five Alpha
Reductase Inhibitor for the Treatment
of
BPH.
|
A
Forty-Five Day Open-Label Study of The Symptomatic Relief of XXXX Capsules
0.4 mg Daily In Patients with
|
the
Signs and Symptoms of Benign Prostatic Hyperplasia.
Ca Prostate
|
A
Phase I/II Study Of A Gonadotropin Releasing Hormone (GNRH) Fusion Protein
Vaccine XXXX In Men With
|
Cancer
of The Prostate.
|
A
Phase III, Multi- Center, Open- Label, Randomized Study of XXXX vs. Lupron-
Depot 1- Month in Patients
|
with
Prostate Cancer Who Are Candidates for Initial Hormonal Therapy.
|
A
Phase III, Multi-center, Open- Label, Randomized Study of XXXX vs. Lupron
Depot 1-Month in Patients with
|
Prostate
Cancer Who Are Candidates for
Initial Hormonal Therapy.
|
A
Phase I study of XXXX and Photodynamic Therapy to determine prostate tissue
concentration and plasma
|
pharmacokinetics.
|
A
Randomized, Double- Blind, Placebo -Controlled, Multicenter, Comparative,
Safety and Efficacy Study of
|
Intravenous
XXXX ( 4 and 8 mg) in Prostate Cancer Patients with Metastatic Bone Lesions
Receiving
Antineoplastic
Therapy.
|
An
Extension Study to Evaluate the Safety and Tolerability of XXXX in Subjects
with Hormone Refractory
|
Adenocarcinoma
of the Prostate.
|
Dose
Ranging Study Comparing Best Medical Therapy With and Without XXXX for the
Treatment of Pain in Men
|
with
Symptomatic Hormone Refractory Adenocarcinoma of the Prostate.
|
An
Open-label, Dose Escalation study of XXXX, Administered as IM or SC in PCA
Patients who are candidates
|
for
initial hormonal therapy.
|
A
XXXX Implant System for Prostate Cancer Patients.
Enrollment is 3 months from initiation. |
|
A
Multi-Center, Open Label, Dose Escalation Study of the Safety and
Therapeutic Effects of XXXX Depot,
|
Administered
as an Intra-muscular (IM) or Subcutaneous (SC) Injections, In Prostate Cancer
Patients who are
Candidates
for Initial Hormone Therapy.
|
A
Clinical Trial to Assess Efficacy and Safety of XXXX in Patients With
Hormone-Refractory Stage D2
|
Prostate
Cancer.
|
Extension
of A Prospective Study Comparing Intermittent Versus Continuous Androgen
Deprivation With
|
XXXX
Depot in Clinical Stage D2 Prostate Cancer.
|
A
Randomized Prospective Study Comparing Intermittent Versus Continuous
Androgen Deprivation With XXXX
|
Depot
in Clinical Stage D2 Prostate Cancer.
|
Randomized
Prospective Study Comparing Intermittent Vs. Continuous Androgen Deprivation
With XXXX In
|
Clinical
Stage D2 Prostate Cancer.
|
Randomized
Double-Blind Comparative trial of XXXX Versus Placebo in Patients with Early
Prostate Cancer. |
Carcinoma In Situ - Bladder
|
A
Phase I/II Open-Label Pilot Study Comparing Bladder Cancer Detection Using
Transurethral Bx's Guided By
|
White
Light And By XXXX-Induced Fluroescence
|
Effect
of XXXX vs BCG in patients newly diagnosed with bladder CIS
|
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