Astellas Pharma - Database of Clinical Trials by Pharmaceutical Companies

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Drug Interaction Study of Isavuconazole and Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone

Conditions: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Ethinyl Estradiol and Norethindrone; Healthy Volunteers
Interventions: Drug: isavuconazole; Drug: Oral Contraceptive (ethinyl estradiol / norethindrone)
Sponsors: Astellas Pharma Inc; Astellas Pharma Global Development, Inc.; Basilea Pharmaceutica International Ltd
Active, not recruiting - verified May 2012
Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer

Condition: Breast Cancer
Intervention: Drug: enzalutamide
Sponsors: Medivation, Inc.; Medivation, Inc.; Astellas Pharma Inc
Recruiting - verified May 2012
A Multiple Dose Escalation Study of ASKP1240 in Subjects With Moderate to Severe Plaque Psoriasis

Condition: Psoriasis
Interventions: Drug: ASKP1240; Drug: Placebo
Sponsors: Astellas Pharma Inc; Astellas Pharma Global Development, Inc.; Kyowa Hakko Kirin Company, Limited
Recruiting - verified April 2012
Drug Interaction Study of Isavuconazole and Methadone

Conditions: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Methadone; Healthy Volunteers
Interventions: Drug: Isavuconazole; Drug: Methadone
Sponsors: Astellas Pharma Inc; Astellas Pharma Global Development, Inc.; Basilea Pharmaceutica International Ltd
Recruiting - verified April 2012
Drug Interaction Study of Isavuconazole and Digoxin

Conditions: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Digoxin; Healthy Volunteers
Interventions: Drug: Isavuconazole; Drug: digoxin
Sponsors: Astellas Pharma Inc; Astellas Pharma Global Development, Inc.; Basilea Pharmaceutica International Ltd
Active, not recruiting - verified April 2012
Bioavailability of ASKP1240 in Healthy Subjects After Intravenous and Subcutaneous Administration of ASKP1240

Conditions: Pharmacokinetics of ASKP1240; Pharmacodynamics of ASKP1240; Healthy Volunteers
Intervention: Drug: ASKP1240
Sponsors: Astellas Pharma Inc; Astellas Pharma Global Development, Inc.; Kyowa Hakko Kirin Pharma, Inc.
Active, not recruiting - verified April 2012
A Study to Investigate the Effect of Mirabegron (YM178) on Subjects With Mild or Moderate Hepatic Impairment Compared to Healthy Subjects

Conditions: Pharmacokinetics; Healthy Subjects; Mild and Moderate Hepatic Impairment
Intervention: Drug: mirabegron
Sponsors: Astellas Pharma Inc; Astellas Pharma Europe BV
Completed - verified April 2012
An Open Label Study to Evaluate the Safety and Efficacy of Two Doses of Quizartinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Condition: Leukemia, Myeloid, Acute
Intervention: Drug: AC220
Sponsors: Astellas Pharma Inc; Astellas Pharma Global Development, Inc.; Ambit Biosciences Corporation
Recruiting - verified May 2012
A Study to Evaluate the Safety and Efficacy of ASP015K Monotherapy in Moderate to Severe Rheumatoid Arthritis

Condition: Arthritis, Rheumatoid
Interventions: Drug: ASP015K; Drug: Placebo
Sponsors: Astellas Pharma Inc; Astellas Pharma Global Development, Inc.
Not yet recruiting - verified May 2012
Study of the Effect of Repeat Doses of Isavuconazole on Cardiac Repolarization

Conditions: Pharmacokinetics of Isavuconazole; Healthy Volunteers
Interventions: Drug: Isavuconazole; Drug: Placebo; Drug: Moxifloxacin
Sponsors: Astellas Pharma Inc; Astellas Pharma Global Development, Inc.; Basilea Pharmaceutica International Ltd
Recruiting - verified April 2012
A Study to Investigate How Effective and Safe Solifenacin Liquid Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug

Conditions: Urinary Bladder; Overactive
Interventions: Drug: Solifenacin succinate; Drug: Placebo; Behavioral: Urotherapy
Sponsors: Astellas Pharma Inc; Astellas Pharma Europe BV
Not yet recruiting - verified March 2012
A Study to Assess the Long Term Effect, Safety and Metabolism of a Solifenacin Liquid Suspension in Patients 5 to 18 Years of Age With Neurogenic Detrusor Overactivity

Condition: Neurogenic Detrusor Overactivity
Intervention: Drug: Solifenacin succinate
Sponsors: Astellas Pharma Inc; Astellas Pharma Europe BV
Not yet recruiting - verified March 2012
Stereotactic Radiosurgery or Other Local Ablation Then Erlotinib in Epidermal Growth Factor Receptor (EGFR)

Condition: Non Small Cell Lung Cancer
Interventions: Procedure: Stereostatic Radiosurgery; Drug: Erlotinib
Sponsors: UNC Lineberger Comprehensive Cancer Center; UNC Lineberger Comprehensive Cancer Center; Astellas Pharma Global Development, Inc.
Active, not recruiting - verified April 2012
Study of ASKP1240 After a Single Intravenous Dose at Escalating Dose Levels in Healthy Subjects

Conditions: Pharmacokinetics of ASKP1240; Healthy Volunteers
Interventions: Drug: ASP1240; Drug: Placebo
Sponsors: Astellas Pharma Inc; Astellas Pharma Global Development, Inc.; Kyowa Hakko Kirin Pharma, Inc.
Completed - verified March 2012
A Study to Assess the Safety and Pharmacokinetics of Isavuconazole in Healthy Chinese Volunteers

Conditions: Pharmacokinetics of BAL4815; Pharmacokinetics of BAL8728; Healthy Volunteers
Interventions: Drug: Isavuconazole; Drug: Isavuconazole (IV)
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc; Basilea Pharmaceutica International Ltd
Not yet recruiting - verified April 2012
Study of the Effect of Renal Impairment on the Pharmacokinetics of Isavuconazole.

Conditions: Pharmacokinetics of Isavuconazole; Healthy Volunteers; Renal Impaired
Intervention: Drug: isavuconazole
Sponsors: Astellas Pharma Inc; Astellas Pharma Global Development, Inc.; Basilea Pharmaceutica International Ltd
Recruiting - verified April 2012
TOP-Study (Tacrolimus Organ Perfusion): Treatment of Ischemia Reperfusion Injury in Marginal Organs With an ex Vivo Tacrolimus Perfusion

Conditions: Terminal Liver Disease; Ischemia Reperfusion Injury; Graft Dysfunction; Graft Failure; Poor Graft Quality
Interventions: Drug: Tacrolimus; Drug: HTK/Placebo
Sponsors: Ludwig-Maximilians - University of Munich; Ludwig-Maximilians - University of Munich
Recruiting - verified March 2012
A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate

Condition: Arthritis, Rheumatoid
Interventions: Drug: ASP015K; Drug: Placebo
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Suspended - verified May 2012
Sodium Management in Acute Neurological Injury

Condition: The Focus of the Study is to Understand the Current Practice of Sodium Management in Patients With Acute Neurological Injury.
Intervention:
Sponsors: Washington University School of Medicine; Washington University School of Medicine; Astellas Pharma Inc
Recruiting - verified March 2012
Incontinence & Intimate Partners: Assessing the Contribution of Treatment

Condition: Urge Urinary Incontinence
Intervention: Drug: solifenacin succinate
Sponsors: Loyola University; Loyola University; Astellas Pharma US, Inc.
Recruiting - verified April 2012
Study of MDV3100 as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer

Condition: Prostate Cancer
Interventions: Drug: MDV3100; Drug: MDV3100 + Leuprolide + Dutasteride
Sponsors: Medivation, Inc.; Medivation, Inc.; Astellas Pharma Inc
Not yet recruiting - verified March 2012
An Exploratory Study to Investigate Bladder Contractions in the Storage Phase and Related Bladder Sensations in Healthy Females and Females With Overactive Bladder (OAB) Using High Resolution and Conventional Urodynamics

Conditions: Healthy Subjects; Overactive Bladder
Interventions: Procedure: High resolution urodynamic assessment; Procedure: Conventional urodynamic assessment
Sponsors: Astellas Pharma Inc; Astellas Pharma Europe Ltd.
Recruiting - verified March 2012
To Determine the Feasibility of a Fidaxomicin Study in Neonates and to Assess C. Difficile (Clostridium Difficile) Involvement in the Pathogenesis

Condition: Clostridium Difficile
Intervention:
Sponsors: Astellas Pharma Inc; Astellas Pharma Europe BV
Recruiting - verified April 2012
Drug Interaction Study of Isavuconazole and Tacrolimus

Conditions: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Tacrolimus; Healthy Volunteers
Interventions: Drug: isavuconazole; Drug: tacrolimus
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc; Basilea Pharmaceutica International Ltd
Completed - verified February 2012
A Study to Evaluate the Efficacy and Safety of a Single Application of QUTENZA Compared to That of Placebo in Reducing Pain Intensity in Subjects With Painful Diabetic Peripheral Neuropathy (PDPN)

Conditions: Diabetic Peripheral Neuropathy; Pain
Interventions: Drug: QUTENZA; Drug: Placebo
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Recruiting - verified May 2012
A Study to Look at How a Single Oral Dose of 14C-OSI-906 is Absorbed, Broken Down and Eliminated in the Body

Conditions: Advanced Solid Tumors; Pharmacokinetics of 14C-OSI-906
Interventions: Drug: radio-labeled OSI-906; Drug: OSI-906
Sponsors: Astellas Pharma Inc; Astellas Pharma Global Development, Inc.
Recruiting - verified February 2012
Single Dose Study to Measure Blood Levels and Safety of a Drug for Children With Overactive Bladder

Conditions: Overactive Bladder; Neurogenic Detrusor Overactivity
Intervention: Drug: Solifenacin succinate
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Not yet recruiting - verified February 2012
A Study to Assess the Safety of Continued Administration of MDV3100 in Subjects With Prostate Cancer Who Showed Benefit From Prior Exposure to MDV3100

Condition: Castration-Resistant Prostate Cancer (CRPC)
Intervention: Drug: MDV3100
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc; Medivation, Inc.
Enrolling by invitation - verified February 2012
Study of Overactive Bladder in Women With Prolapse

Conditions: Urinary Bladder, Overactive; Pelvic Organ Prolapse
Intervention: Other: Pre- and postoperative evaluations
Sponsors: Radboud University; Radboud University; Astellas Pharma Inc; Continentie Stichting Nederland (Continence Foundation The Netherlands)
Recruiting - verified January 2012
Safety and Tolerability Study of MDV3100 in Combination With Docetaxel in Men With Advanced Prostate Cancer

Condition: Prostate Cancer
Intervention: Drug: MDV3100
Sponsors: Medivation, Inc.; Medivation, Inc.; Astellas Pharma Inc
Recruiting - verified March 2012
Topical Local Anaesthesia and Cooling During Capsaicin 8% Patch Application

Condition: Pain
Intervention:
Sponsors: Medical University of Vienna; Medical University of Vienna; Astellas Pharma GmbH
Completed - verified March 2012
A Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes Mellitus

Condition: Type II Diabetes Mellitus
Interventions: Drug: ASP1941; Drug: acarbose; Drug: Placebo
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Recruiting - verified January 2012
A Study to Investigate the Effect of YM150 on the Plasma Concentration of Digoxin in Healthy Subjects

Conditions: Healthy; Pharmacokinetic of Digoxin
Interventions: Drug: YM150; Drug: placebo; Drug: digoxin
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Completed - verified January 2012
A Study to Investigate the Plasma Concentration of YM150 After Repeated Administration to Elderly Subjects

Conditions: Healthy Elderly Subject; Pharmacokinetic of YM150
Interventions: Drug: YM150; Drug: Placebo
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Completed - verified January 2012
A Study to Estimate the Efficacy and Safety of Solifenacin in Female With Stress Urinary Incontinence and Urgency Urinary Incontinence

Conditions: Stress Urinary Incontinence; Urgency Urinary Incontinence
Intervention: Drug: solifenacin
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc; Astellas Pharma Korea, Inc.
Recruiting - verified January 2012
A Study is to Assess Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Who Showed Unsuccessful Response to Existing Disease Modifying Antirheumatic Drugs (DMARDs)

Condition: Rheumatoid Arthritis
Intervention: Drug: Tacrolimus
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc; Astellas Pharma Korea, Inc.
Recruiting - verified January 2012
A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Diabetes Patients

Condition: Type II Diabetes Mellitus
Interventions: Drug: ASP1941; Drug: metformin; Drug: Placebo
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Recruiting - verified January 2012
Drug Interaction Study of Isavuconazole and Cyclosporine

Condition: Healthy
Interventions: Drug: isavuconazole; Drug: cyclosporine
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc; Basilea Pharmaceutica International Ltd
Completed - verified December 2011
Half-Dose Radiopharmaceutical in Wide Beam Reconstruction

Conditions: Myocardial Infarction; Ischemic Heart Disease
Intervention: Drug: Half-dose of the Tc99-m sestamibi (Cardiolite)
Sponsors: Northwestern University; Edwin Wu; Astellas Pharma Global Development, Inc.
Recruiting - verified December 2011
Post Marketing Survey of Vesicare in Japan

Condition: Overactive Bladder
Intervention: Drug: Vesicare
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Completed - verified December 2011
A Single Oral Dose Study of ASP015K in Healthy Volunteers Assessing the Relative Bioavailability Across Three Tablet Strengths From a New Formulation of ASP015K

Conditions: Bioavailability of ASP015K; Pharmacokinetics of ASP015K; Healthy Subjects
Intervention: Drug: ASP015K
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Completed - verified December 2011
A Single Oral Dose Study to Compare the Bioavailability Between Two Different Tablet Formulations and Assess if There is a Food Effect With the New Formulation

Conditions: Pharmacokinetics of ASP015K; Bioavailability of ASP015K; Healthy Subjects
Intervention: Drug: ASP015K
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Completed - verified December 2011
Regadenoson Real Time Perfusion Imaging Trial-Optison

Conditions: Coronary Artery Disease; Myocardial Perfusion Abnormalities
Intervention: Drug: Regadenoson; Optison
Sponsors: University of Nebraska; Thomas R. Porter, MD; Astellas Pharma US, Inc.; GE Healthcare
Not yet recruiting - verified December 2011
A Study Combining mFOLFOX6 With Tivozanib or Bevacizumab in Patients With Metastatic Colorectal Cancer as First Line Therapy

Condition: Colorectal Cancer
Interventions: Drug: Tivozanib; Drug: Bevacizumab; Drug: mFOLFOX6
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc; AVEO Pharmaceuticals, Inc.
Recruiting - verified March 2012
A Study to Evaluate the Long-term Safety of Repeated QUTENZA Administration for Treatment of Pain Caused by Nerve Damage in Diabetic Patients

Condition: Painful Diabetic Peripheral Neuropathy (PDPN)
Intervention: Drug: QUTENZA
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Recruiting - verified March 2012
To Compare Blood and Urine Concentrations of Mirabegron (YM178) in Healthy Poor or Extensive Metabolizers for CYP2D6 and to Assess the Effect of Mirabegron on the Metabolism of Metoprolol

Conditions: Pharmacokinetics of Mirabegron; Healthy Subjects
Interventions: Drug: mirabegron; Drug: metoprolol
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Completed - verified November 2011
To Evaluate the Blood and Urine Concentration and the Safety and Tolerability of Increasing Repeated Doses of Mirabegron (YM178) OCAS in Healthy Young and Elderly Males and Healthy Young and Elderly Females

Conditions: Pharmacokinetics; Healthy Subjects
Interventions: Drug: mirabegron OCAS; Drug: Placebo
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Completed - verified November 2011
A Study to Evaluate Cardiovascular Interactions Between Mirabegron and Tamsulosin

Conditions: Cardiovascular; Healthy Subjects; Pharmacokinetics
Interventions: Drug: mirabegron; Drug: tamsulosin
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Completed - verified December 2011
A Study to Find Out How Much Mirabegron Gets Into the Body After Dosing With a Tablet Formulation

Conditions: Pharmacokinetics of Mirabegron; Bioavailability; Healthy Subjects
Interventions: Drug: mirabegron OCAS; Drug: mirabegron
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Completed - verified November 2011
To Evaluate the Effect of Mirabegron (YM178) on Blood Levels of Desipramine When They Are Taken Together

Conditions: Pharmacokinetics of Mirabegron; Healthy Subjects
Interventions: Drug: mirabegron; Drug: desipramine
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Completed - verified November 2011
A Study to Assess Pharmacokinetic Interaction of Multiple Dose Ketoconazole on Single Dose YM178 Oral Controlled Absorption System (OCAS) in Healthy Adult Volunteers

Conditions: Healthy Subjects; Pharmacokinetics of YM178
Interventions: Drug: YM178 OCAS; Drug: Ketoconazole
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Completed - verified November 2011
A Study of AC220 Given After Transplant in Subjects With Acute Myeloid Leukemia (AML)

Condition: Leukemia, Myeloid, Acute,
Intervention: Drug: AC220
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc; Ambit Biosciences Corporation
Recruiting - verified May 2012
Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve (FFR)

Condition: Coronary Artery Disease
Intervention: Drug: FFR Measurement with IV Adenoscan® then with Regadenoson
Sponsors: Ochsner Health System; Ochsner Health System; Astellas Pharma Global Development, Inc.
Recruiting - verified March 2012
Pilot Trial Of Urinary Nerve Growth Factor (NGF) As Biomarker for Male Lower Urinary Tract Symptoms

Condition: Lower Urinary Tract Symptoms
Intervention: Drug: Solifenacin (Vesicare) 5 mg orally at the same time.
Sponsors: The Methodist Hospital System; The Methodist Hospital System; Astellas Pharma US, Inc.
Recruiting - verified October 2011
A Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous Conivaptan (Vaprisol®) in Pediatric Subjects With Euvolemic or Hypervolemic Hyponatremia

Condition: Hyponatremia
Interventions: Drug: Conivaptan hydrochloride; Drug: Placebo
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Recruiting - verified April 2012
Ramosetron, Aprepitant and Dexamethasone Versus Ondansetron, Aprepitant and Dexamethasone

Conditions: Cancer; Malignancy
Interventions: Drug: ramosetron; Drug: ondansetron
Sponsors: Hallym University Medical Center; Hallym University Medical Center; Korean Cancer Study Group; Astellas Pharma Korea, Inc.
Recruiting - verified February 2012
Special Drug Use-Results Survey of Lipitor Tablets

Condition: Hypercholesterolemia
Intervention: Drug: atrovastatin
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Recruiting - verified October 2011
A Study to Evaluate the Immune Response to the ASP7373 and Its Safety in Healthy Adult Volunteers

Condition: Healthy
Interventions: Biological: ASP7373; Biological: Placebo
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc; UMN Pharma Inc.
Completed - verified January 2012
A Study to Evaluate the Effect of ASP8597 in Adult Kidney Transplant Patients

Condition: Kidney Transplantation
Interventions: Drug: ASP8597; Drug: Placebo
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Recruiting - verified April 2012
Clinical Progression and Costs in Benign Prostatic Hyperplasia Patients Treated With Early Versus Delayed Combination Therapy

Condition: Benign Prostatic Hyperplasia
Interventions: Drug: Early combination therapy; Drug: Delayed combination therapy
Sponsors: GlaxoSmithKline; GlaxoSmithKline
Completed - verified July 2011
Diagnostic Study of Rapid Regadenoson Stress Cardiovascular Magnetic Resonance (CMR) to Detect Coronary Artery Disease

Condition: Coronary Artery Disease
Intervention: Drug: Regadenoson
Sponsors: The Methodist Hospital System; The Methodist Hospital System; Astellas Pharma Global Development, Inc.
Recruiting - verified September 2011
Graft Rejection or Tolerance Affected by Serial Change of Anti-donor Lymphocyte Antibody After Liver Transplantation

Condition: Liver Transplant Rejection
Intervention:
Sponsors: Yonsei University; Yonsei University; Astellas Pharma Korea, Inc.
Recruiting - verified February 2012
A Study to Evaluate Safety of Multiple Dose of ASP0456 in Healthy Subjects

Conditions: Healthy; Pharmacokinetics of ASP0456
Interventions: Drug: ASP0456; Drug: Placebo
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Completed - verified September 2011
Alefacept in Kidney Transplant Recipients

Condition: Kidney Transplantation
Intervention: Drug: Amevive
Sponsors: University Hospital Case Medical Center; University Hospital Case Medical Center; Astellas Pharma Global Development, Inc.
Withdrawn - verified February 2012
Effect of Ramosetron on Bowel Motility After Colorectal Resection

Condition: Postoperative Nausea and Vomiting
Intervention: Drug: Ramosetron
Sponsors: Kyunghee University Medical Center; Kyunghee University Medical Center
Recruiting - verified August 2011
Study to Compare Pharmacokinetic Profiles of TRK-100STP in Japanese, Chinese, and South Korean Non-elderly Healthy Adult Males

Conditions: Healthy Adult Male; Pharmacokinetics of TRK-100-STP
Intervention: Drug: TRK-100STP
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc; Toray Industries, Inc
Completed - verified October 2011
Method of Pre-treatment for Application of QUTENZA Capsaicin 8% Patch

Conditions: Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN); Peripheral Nerve Injury
Interventions: Drug: QUTENZA; Drug: Lidocaine; Drug: Tramadol
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Recruiting - verified August 2011
A Study to Evaluate the Safety and Efficacy of Tacrolimus for Lupus Nephritis Under Actual Use Situations

Condition: Lupus Nephritis
Intervention: Drug: Tacrolimus
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Recruiting - verified August 2011
To Evaluate Whether Acetyl Salicylic Acid (Aspirin) and Darexaban (YM150) Interact in Their Effects

Conditions: Pharmacodynamic and Pharmacokinetic Interaction; Healthy Subjects
Interventions: Drug: Darexaban; Drug: Acetyl Salicylic Acid (ASA)
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Completed - verified August 2011
To Evaluate Whether Naproxen and Darexaban (YM150) Interact in Their Effects

Conditions: Pharmacodynamic Interaction; Healthy Subjects
Interventions: Drug: darexaban; Drug: Naproxen
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Completed - verified August 2011
To Evaluate Whether Acetyl Salicylic Acid (Aspirin), the Combination of Aspirin and Clopidogrel and Darexaban (YM150) Interact in Their Effects

Conditions: Pharmacodynamic Interaction; Healthy Subjects
Interventions: Drug: darexaban; Drug: darexaban (double dose); Drug: Acetyl Salicylic Acid; Drug: clopidogrel
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Completed - verified August 2011
The Risk of Venous Clotting in Patients After Renal Transplant

Conditions: Venous Thrombosis; End Stage Renal Failure With Renal Transplant; Deep Vein Thrombosis; Pulmonary Embolism
Intervention:
Sponsors: St. Joseph's Healthcare Hamilton; St. Joseph's Healthcare Hamilton; Astellas Pharma Canada, Inc.
Recruiting - verified August 2011
To Evaluate if Multiple Doses of Rifampicin Change the Blood Concentration of YM150 (Darexaban)

Conditions: Pharmacokinetics of Darexaban and Metabolites; Healthy Subjects
Interventions: Drug: darexaban; Drug: Rifampicin
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Completed - verified July 2011
To Evaluate if Multiple Doses of Ketoconazole Change the Blood Concentration of YM150 (Darexaban)

Conditions: Pharmacokinetics of Darexaban and Metabolites; Healthy Subjects
Interventions: Drug: darexaban; Drug: ketoconazole
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Completed - verified July 2011
A Study to Assess the Effect of ASP1941 and Mitiglinide on Their Plasma Concentration

Conditions: Healthy; Pharmacokinetics of ASP1941; Pharmacokinetics of Mitiglinide
Interventions: Drug: ASP1941; Drug: Mitiglinide calcium hydrate
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Completed - verified October 2011
A Study of the Safety and Pharmacokinetics of AGS-22M6E in Subjects With Malignant Solid Tumors That Express Nectin-4

Conditions: Tumors; Medical Oncology; Neoplasms
Intervention: Drug: AGS-22M6E
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc; Agensys, Inc.; Seattle Genetics, Inc.
Recruiting - verified March 2012
A Study in Healthy Volunteers Comparing Two Different Liquid Formulations of Solifenacin With Each Other and With the Tablet Formulation

Conditions: Pharmacokinetics of Solifenacin Succinate; Healthy Volunteers
Interventions: Drug: Solifenacin Succinate Formulation A; Drug: Solifenacin Succinate Formulation B; Drug: Solifenacin Succinate
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Completed - verified August 2011
A Study to Evaluate the Immune Response to the ASP7374 and Its Safety in Healthy Adult Volunteers

Conditions: Healthy; Immunogenicity of ASP7374
Intervention: Biological: ASP7374
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc; UMN Pharma Inc.
Completed - verified January 2012
A Study to Compare Oral Absorption of YM060 Between Orally-disintegrating Tablet (Without Water) and Conventional Tablet

Conditions: Healthy; Plasma Concentration of YM060
Intervention: Drug: YM060
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Completed - verified July 2011
A Study to Compare Oral Absorption of YM060 Between Orally-disintegrating Tablet and Conventional Tablet Under With Water Intake

Conditions: Healthy; Plasma Concentration of YM060
Intervention: Drug: YM060
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Completed - verified October 2011
A Clinical Study to Investigate the Efficacy, Safety and Pharmacokinetics of ASP3652 in Patients With Chronic Abacterial Prostatitis / Chronic Pelvic Pain Syndrome (CP/CPPS)

Conditions: Chronic Abacterial Prostatitis; Chronic Pelvic Pain Syndrome
Interventions: Drug: ASP3652; Drug: Placebo
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Recruiting - verified November 2011
A Study to Assess AC220 Given in Combination With Induction and Consolidation Therapy in Newly Diagnosed Acute Myeloid Leukemia (AML)

Condition: Leukemia, Myeloid, Acute
Interventions: Drug: AC220; Drug: daunorubicin; Drug: cytarabine
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc; Ambit Biosciences Corporation
Recruiting - verified May 2012
Drug Interaction Study of Isavuconazole and Midazolam

Conditions: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Midazolam; Healthy Volunteers
Interventions: Drug: Isavuconazole; Drug: Midazolam
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc; Basilea Pharmaceutica
Completed - verified July 2011
A Study of the Safety and Tolerability of ASP0777 in Subjects With Alzheimer's Disease (AD) Taking a Stable Dose of Donepezil

Condition: Alzheimer's Disease
Interventions: Drug: ASP0777; Drug: Placebo
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Completed - verified November 2011
Study of an Investigational Drug, ASP3026, in Patients With Solid Tumors

Condition: Solid Tumor
Intervention: Drug: ASP3026
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Recruiting - verified July 2011
A Study to Assess the Pharmacokinetics of ASP015K in Healthy Male Subjects

Conditions: Healthy Subjects; Pharmacokinetics of ASP015K
Intervention: Drug: ASP015K
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Completed - verified July 2011
Pharmacokinetic Interaction Study to Assess the Effect of ASP015K on Tacrolimus in Healthy Volunteers

Conditions: Pharmacokinetics of ASP015K; Drug Interactions; Healthy Subjects
Interventions: Drug: ASP015K; Drug: Tacrolimus
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Completed - verified September 2011
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP015K

Conditions: Healthy Subjects; Pharmacokinetics of ASP015K
Interventions: Drug: ASP015K; Drug: Placebo
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Completed - verified June 2011
Advagraf/Prograf Conversion Trial

Condition: Renal Transplant
Intervention: Drug: Tacrolimus
Sponsors: Lawson Health Research Institute; Lawson Health Research Institute; Astellas Pharma Canada, Inc.
Recruiting - verified August 2011
A Study to Assess Efficacy and Safety With VESIcare® to Improve Urinary Continence in Subjects After Robotic Assisted Radical Prostatectomy

Condition: Urinary Incontinence
Interventions: Drug: solifenacin succinate; Drug: Placebo
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Recruiting - verified March 2012
A Paediatric, Open, Follow up Study With Modigraf Examining Safety and Efficacy in de Novo Allograft Recipients

Conditions: Liver Transplantation; Kidney Transplantation; Heart Transplantation
Interventions: Drug: Tacrolimus granules; Drug: Tacrolimus
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Recruiting - verified April 2012
A Study to Determine Pharmacokinetics of Children Receiving Modigraf (Tacrolimus Granules) Following Solid Organ Transplantation

Conditions: Liver Transplantation; Kidney Transplantation; Heart Transplantation
Intervention: Drug: Tacrolimus granules
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Recruiting - verified April 2012
A Study to Assess the Effect of Severe Hepatic Impairment on the Pharmacokinetics of Intravenous Conivaptan

Condition: Liver Disease
Intervention: Drug: conivaptan hydrochloride
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Recruiting - verified March 2012
A Study to Assess the Bioavailability of ASP015K

Condition: Healthy
Interventions: Drug: ASP015K; Drug: ASP015K
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Completed - verified September 2011
A Study Looking at Kidney Function in Kidney Transplant Recipients Who Are Taking Anti-rejection Medication Including Tacrolimus and With or Without Sirolimus.

Condition: Kidney Transplantation
Interventions: Drug: Advagraf; Drug: Mycophenolate Mofetil; Drug: Sirolimus; Drug: Corticosteroids
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Recruiting - verified September 2011
A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of ASP1941 in Healthy Male Taiwanese Subjects

Conditions: Healthy; Pharmacokinetics of ASP1941
Interventions: Drug: ASP1941; Drug: Placebo
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc; Astellas Pharma Taiwan, Inc.
Completed - verified October 2011
Pharmacokinetic Interaction Study to Assess the Effect of ASP015K on Mycophenolate Mofetil in Healthy Volunteers

Conditions: Healthy Subjects; Drug Interactions; Pharmacokinetics of ASP015K
Interventions: Drug: ASP015K; Drug: Mycophenolate Mofetil
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Completed - verified June 2011
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP015K

Conditions: Healthy Subjects; Pharmacokinetics of ASP015K; Pharmacodynamics
Interventions: Drug: ASP015K; Drug: Placebo
Sponsors: Astellas Pharma Inc; Astellas Pharma Inc
Completed - verified May 2011