Eisai - Database of Clinical Trials by Pharmaceutical Companies

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Evaluation of E2609 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease

Condition: Alzheimer's Disease
Interventions: Drug: E2609; Drug: Placebo
Sponsors: Eisai Inc.; Eisai Inc.
Not yet recruiting - verified May 2012
Phase Ib/II Study of PLX 3397 and Eribulin in Patients With Metastatic Breast Cancer

Condition: Metastatic Breast Cancer
Interventions: Drug: PLX3397; Drug: Eribulin
Sponsors: University of California, San Francisco; Hope Rugo, MD; Susan G. Komen Breast Cancer Foundation; Plexxikon, Inc.; Eisai Inc.
Not yet recruiting - verified May 2012
Neoadjuvant Study of Sequential Eribulin Followed by FAC Compared to Sequential Paclitaxel Followed by FEC in Early Stage Breast Cancer Not Overexpressing HER-2

Condition: Breast Cancer
Interventions: Drug: Paclitaxel; Drug: Eribulin; Drug: 5-Fluorouracil; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Doxorubicin
Sponsors: M.D. Anderson Cancer Center; M.D. Anderson Cancer Center; Eisai Inc.
Not yet recruiting - verified May 2012
Eribulin in Combination With Cyclophosphamide in Patients With Solid Tumor Malignancies

Conditions: Malignant Solid Tumour; Breast Cancer Nos Metastatic Recurrent; Neuropathy
Intervention: Drug: Eribulin in Combination w/ Cyclophosphamide
Sponsors: University of California, San Francisco; University of California, San Francisco; Eisai Inc.
Not yet recruiting - verified March 2012
Clinical Course of Korean Crohn's Disease Cohort

Condition: Crohn's Disease
Intervention: Other: Observation study
Sponsors: Kyunghee University Medical Center; Kyunghee University Medical Center; Asan Medical Center; Hanyang university Guri Hospital; Inje University; Seoul National University; Yonsei University; Eisai Korea Inc.; Samsung Medical Center; The Catholic University of Korea; Chung-Ang University
Not yet recruiting - verified March 2012
A Study to Evaluate the Safety and Tolerability and Explore the Efficacy of Zonisamide as add-on Therapy in Elderly Patients With Refractory Partial Seizures

Condition: Epilepsy
Interventions: Drug: Zonisamide 25 mg; Drug: Zonisamide 50 mg; Drug: Zonisamide 100 mg; Drug: Placebo
Sponsors: Eisai Inc.; Eisai Limited
Terminated - verified March 2012
Compare the Efficacy and Safety of Donepezil Hydrochloride 23 mg Treatment With Continuation of Donepezil Hydrochloride 10 mg Treatment in Japanese Subjects With Severe Alzheimer's Disease

Condition: Alzheimer's Type Dementia
Interventions: Drug: E2020; Drug: E2020
Sponsors: Eisai Inc.; Eisai Co., Ltd.
Recruiting - verified March 2012
A Study in Healthy Subjects to Determine the Effects When Alcohol is Administered With Perampanel

Condition: Central Nervous System
Interventions: Drug: alcohol + placebo; Drug: alcohol + perampanel; Drug: perampanel + alcohol; Drug: placebo + alcohol
Sponsors: Eisai Inc.; Eisai Limited
Completed - verified January 2012
A Study in Healthy Subjects to Evaluate Bioavailability of 4 Formulations of E5501

Condition: Idiopathic Thrombocytopenic Purpura
Interventions: Drug: 10-mg dose of E5501 2G tablet; Drug: 10-mg dose of E5501 cyclodextrin oral solution; Drug: 10-mg dose of E5501-P21% powder; Drug: 10-mg dose of E5501 lipid-based oral
Sponsors: Eisai Inc.; Eisai Inc.
Recruiting - verified March 2012
A Double-Blind Study in Healthy Volunteers to Assess the Effect of E7080 on the QTc Interval

Conditions: Refractory Solid Tumors; Lymphomas
Interventions: Drug: E7080; Drug: Moxifloxacin 400 mg; Drug: Placebos (matched to 4 mg and 10 mg E7080 capsules).
Sponsors: Eisai Inc.; Eisai Inc.
Completed - verified April 2012
Trial of Eribulin/Cyclophosphamide or Docetaxel/Cyclophosphamide as Neoadjuvant Therapy in Locally Advanced HER2-Negative Breast Cancer

Condition: Locally Advanced HER2-Negative Breast Cancer
Interventions: Drug: Eribulin Mesylate; Drug: Cyclophosphamide; Drug: Docetaxel
Sponsors: Sarah Cannon Research Institute; Sarah Cannon Research Institute; Eisai Inc.
Not yet recruiting - verified March 2012
New Dual Therapy for Primary Treatment of Helicobacter Pylori Infection：a Pilot Study

Condition: Functional Dyspepsia
Interventions: Drug: Rabeprazole and Amoxicillin; Drug: Amoxicillin and Rabeprazole
Sponsors: Shanghai Jiao Tong University School of Medicine; Shanghai Jiao Tong University School of Medicine
Completed - verified January 2012
Evaluation of the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of E2609 in Healthy Subjects

Condition: Healthy
Interventions: Drug: E2609; Drug: Placebo
Sponsors: Eisai Inc.; Eisai Inc.
Recruiting - verified May 2012
A Bioequivalence Study Comparing Improved Versus Current Orally Disintegrating E2020 10 mg Tablet in Healthy Japanese Adult Males

Condition: Healthy Adult
Interventions: Drug: Donepezil Hydrochloride; Drug: Donepezil Hydrochloride; Drug: Donepezil Hydrochloride; Drug: Donepezil Hydrochloride
Sponsors: Eisai Inc.; Eisai Co., Ltd.
Completed - verified January 2012
A Bioequivalence Study of Film-coated Tablet and Dry Syrup 1% Form for E2020 in Healthy Japanese Adult Males

Condition: Healthy Adult
Interventions: Drug: Donepezil Hydrochloride; Drug: Donepezil Hydrochloride; Drug: Donepezil Hydrochloride
Sponsors: Eisai Inc.; Eisai Co., Ltd.
Completed - verified January 2012
A Study Comparing the Combination of the Best Supportive Care Plus E7080 Versus Best Supportive Care Alone, in Patients With Advanced Lung Cancer or Lung Cancer That Has Spread, Who Have Been Previously Treated, Unsuccessfully, With at Least 2 Different Treatments

Condition: Non-Small Cell Lung Cancer
Intervention: Drug: Lenvatinib (E7080)
Sponsors: Eisai Inc.; Eisai Inc.; PharmaBio Development Inc.
Not yet recruiting - verified March 2012
Proof-of-Concept Study of E1224 to Treat Adult Patients With Chagas Disease

Condition: Chronic Chagas Disease, Indeterminate
Interventions: Drug: E1224; Drug: Benznidazole; Drug: Placebo
Sponsors: Drugs for Neglected Diseases; Drugs for Neglected Diseases; Eisai Co., Ltd.
Recruiting - verified December 2011
Pharmacokinetics, Efficacy, and Safety of Perampanel Oral Suspension on Seizure Frequency in Pediatric Subjects Maintained on One to Three Stable Antiepileptic Drugs

Condition: Central Nervous System
Intervention: Drug: perampanel
Sponsors: Eisai Inc.; Eisai Inc.
Recruiting - verified January 2012
A Phase 2 Study of E6005 in Patients With Atopic Dermatitis

Condition: Atopic Dermatitis
Interventions: Drug: E6005; Drug: E6005 ointment (vehicle)
Sponsors: Eisai Inc.; Eisai Co., Ltd.
Recruiting - verified March 2012
A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006

Condition: Insomnia
Interventions: Drug: E2006 1.0 mg; Drug: E2006 2.5 mg; Drug: E2006 5.0 mg; Drug: E2006 10.0 mg; Drug: E2006 25.0 mg; Drug: E2006 50.0 mg; Drug: E2006 100 mg; Drug: E2006 200 mg; Drug: zolpidem 10 mg; Drug: zolpidem - matched placebo; Drug: E2006 - matched placebo
Sponsors: Eisai Inc.; Eisai Inc.
Recruiting - verified April 2012
An Open-label, Multi-center, Phase 2 Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Previously Treated Subjects With Advanced Soft Tissue Sarcoma

Condition: Soft Tissue Sarcoma
Intervention: Drug: E7389
Sponsors: Eisai Inc.; Eisai Co., Ltd.
Recruiting - verified December 2011
A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Treatment of Physician's Choice in Subjects With Advanced Non-Small Cell Lung Cancer

Condition: Non-Small Cell Lung Cancer (NSCLC)
Interventions: Drug: Eribulin; Drug: TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed
Sponsors: Eisai Inc.; Eisai Inc.
Recruiting - verified April 2012
Neoadjuvant Trial of Eribulin Followed by Dose Dense Doxorubicin and Cyclophosphamide for Her2-negative, Locally Advanced Breast Cancer

Conditions: Breast Neoplasms; Breast Cancer; Breast Tumors; Cancer of the Breast; Neoplasms, Breast; Tumors, Breast
Interventions: Drug: Eribulin; Drug: Doxorubicin; Drug: Cyclophosphamide
Sponsors: Emory University; Emory University; Eisai Inc.
Recruiting - verified December 2011
E2022 Patch Formulation Multiple Dose Study

Condition: Healthy
Interventions: Drug: E2022; Drug: Placebo
Sponsors: Eisai Inc.; Eisai Co., Ltd.
Recruiting - verified October 2011
Post-marketing Surveillance for the Clinical Safety and Effectiveness of Eribulin Mesilate in Patients With Inoperable or Recurrent Breast Cancer

Condition: Breast Cancer
Intervention: Drug: Eribulin Mesylate
Sponsors: Eisai Inc.; Eisai Co., Ltd.
Recruiting - verified October 2011
Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects Comparing the Interactions Between E5501 and Verapamil and Cyclosporine.

Condition: Idiopathic Thrombocytopenic Purpura (ITP)
Intervention: Drug: E5501
Sponsors: Eisai Inc.; Eisai Inc.
Recruiting - verified November 2011
Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults With Chronic Immune Thrombocytopenia

Conditions: Chronic Thrombocytopenia; Immune Thrombocytopenia
Intervention: Drug: E5501
Sponsors: Eisai Inc.; Eisai Inc.
Recruiting - verified January 2012
Eribulin in Combination With Capecitabine for Adjuvant Treatment in Estrogen Receptor-Positive Early Stage Breast Cancer

Conditions: Estrogen Receptor Positive Tumor; Breast Cancer
Intervention: Drug: E7389 (eribulin mesylate) and capecitabine
Sponsors: Eisai Inc.; Eisai Inc.
Recruiting - verified April 2012
A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group Trial With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Versus Eltrombopag, in Adults With Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)

Condition: Idiopathic Thrombocytopenic Purpura
Interventions: Drug: Eltrombopag; Drug: E5501
Sponsors: Eisai Inc.; Eisai Inc.
Recruiting - verified March 2012
A Study of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epiderma Growth Factor Receptor 2-Positive (HER2+) Breast Cancer

Condition: Breast Cancer
Intervention: Drug: E7389
Sponsors: Eisai Inc.; Eisai Co., Ltd.
Recruiting - verified March 2012
E7050 in Combination With E7080 in Subjects With Advanced Solid Tumors (Dose Escalation) and in Subjects With Recurrent Glioblastoma or Unresectable Stage III or Stage IV Melanoma After Prior Systemic Therapy (Expansion Cohort and Phase 2)

Condition: Advanced Solid Tumors
Interventions: Drug: E7050 plus E7080; Drug: E7080 plus E7050; Drug: E7050 plus E7080 or E7080 alone plus E7050 add-on therapy; Drug: E7050 plus E7080; Drug: E7050
Sponsors: Eisai Inc.; Eisai Inc.
Recruiting - verified March 2012
Access Program With Denileukin Diftitox for the Treatment of Patients Currently Receiving Treatment With Commercially Available (Ontak)

Condition: Cancer
Intervention: Drug: Denileukin diftitox (ONTAK)
Sponsors: Eisai Inc.; Eisai Inc.
Available - verified April 2012
A Phase I Study of E7050 in Subjects With Solid Tumors

Conditions: Solid Tumor; Gastric Cancer
Intervention: Drug: E7050
Sponsors: Eisai Inc.; Eisai Co., Ltd.
Recruiting - verified January 2012
Bioequivalence Study of Torrent Pharmaceutical Limited's Donepezil Hydrochloride Tablets Under Fed Conditions

Condition: Healthy
Intervention: Drug: Torrent's Donepezil Hydrochloride Tablets 10mg
Sponsors: Torrent Pharmaceuticals Limited; Torrent Pharmaceuticals Limited
Completed - verified August 2011
Bioequivalence Study of Torrent Pharmaceutical Limited's Donepezil Hydrochloride Tablets Under Fasting Conditions

Condition: Healthy
Intervention: Drug: Torrent's Donepezil Hydrochloride Tablets 10mg
Sponsors: Torrent Pharmaceuticals Limited; Torrent Pharmaceuticals Limited
Completed - verified August 2011
Treatment of Sickle Cell Patients Hospitalized in Pain Crisis With Prophylactic Dose Low-molecular-weight Heparin (LMWH) Versus Placebo

Conditions: Sickle Cell Disease; Vaso-occlusive Crisis
Interventions: Drug: Placebo; Drug: Dalteparin
Sponsors: Duke University; Duke University; Eisai Limited
Recruiting - verified August 2011
An Open-Label Study to Assess the Pharmacokinetics and Safety of HALAVEN™ in Subjects With Cancer Who Also Have Impaired Renal Function

Condition: Unspecified Adult Solid Tumor, Protocol Specific
Interventions: Drug: E7389; Drug: E7389; Drug: E7389
Sponsors: Eisai Inc.; Eisai Inc.
Recruiting - verified May 2012
A 24-weeks, Multi-center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Donepezil Hydrochloride in Chinese Subjects With Severe Alzheimer's Disease

Condition: Alzheimer's Type Dementia
Interventions: Drug: E2020; Drug: Placebo
Sponsors: Eisai Inc.; Eisai Co., Ltd.
Recruiting - verified February 2012
Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs

Condition: Lennox-Gastaut Syndrome
Interventions: Drug: Rufinamide; Drug: Any other approved AED
Sponsors: Eisai Inc.; Eisai Inc.
Recruiting - verified April 2012
Long-term Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study)

Conditions: Gastric Ulcers; Duodenal Ulcers
Interventions: Drug: E3810; Drug: E3810
Sponsors: Eisai Inc.; Eisai Co., Ltd.
Not yet recruiting - verified October 2011
Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study)

Conditions: Gastric Ulcers; Duodenal Ulcers
Interventions: Drug: E3810; Drug: E3810; Drug: Teprenone
Sponsors: Eisai Inc.; Eisai Co., Ltd.
Recruiting - verified October 2011
A Efficacy and Safety Study of Adjunctive Perampanel in Primary Generalized Tonic Clonic Seizures

Condition: Seizure Disorder Generalized Tonic Clonic
Interventions: Drug: perampanel; Drug: placebo comparator
Sponsors: Eisai Inc.; Eisai Inc.
Recruiting - verified January 2012
Demonstrate Bioequivalence Between 3 x 2-mg Tablets of Perampanel and a Single 6-mg Tablet of Perampanel in Healthy Subjects

Condition: Healthy
Interventions: Drug: perampanel; Drug: perampanel
Sponsors: Eisai Inc.; Eisai Inc.
Completed - verified April 2012
Demonstrate Bioequivalence Between 6 ? 2-mg Tablets of Perampanel and a Single 12-mg Tablet of Perampanel in Healthy Subjects

Condition: Healthy
Interventions: Drug: Perampanel; Drug: Perampanel
Sponsors: Eisai Inc.; Eisai Inc.
Completed - verified April 2012
Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy

Condition: Metastatic Breast Cancer
Interventions: Drug: eribulin mesylate; Drug: eribulin mesylate; Drug: eribulin mesylate, trastuzumab
Sponsors: Sarah Cannon Research Institute; Sarah Cannon Research Institute; Eisai Inc.
Recruiting - verified March 2012
E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma

Conditions: Enteropathy-Associated T-Cell Lymphoma; Anaplastic Large-Cell Lymphoma; Cutaneous T-Cell Lymphoma; Primary Cutaneous Anaplastic Large Cell Lymphoma; Mycosis Fungoides; Sezary Syndrome; Peripheral T-Cell Lymphoma
Intervention: Biological: denileukin diftitox
Sponsors: TSD Japan Inc.; TSD Japan Inc.; Eisai Co., Ltd.
Recruiting - verified July 2011
Study of Neoadjuvant Carboplatin, Eribulin and Trastuzumab for Operable HER2 Positive Breast Cancer

Condition: HER-2 Positive Breast Cancer
Interventions: Drug: eribulin; Drug: carboplatin; Drug: trastuzumab
Sponsors: ACORN Research, LLC; ACORN Research, LLC; Eisai Inc.
Recruiting - verified January 2012
Pharmacodynamic and Pharmacokinetic Study of E3710 Following Oral Administration to Healthy, Male, Japanese Subjects

Condition: Gastroesophageal Reflux Disease
Interventions: Drug: E3710; Drug: E3710
Sponsors: Eisai Inc.; Eisai Co., Ltd.
Completed - verified March 2012
Preventing Propofol Injection Pain: Prospective Randomized Trial Comparing Propofol Versus Fospropofol

Conditions: Complication of Injection; Pain
Interventions: Drug: Fospropofol; Drug: Propofol/Lidocaine
Sponsors: New York University School of Medicine; New York University School of Medicine; Eisai Inc.
Recruiting - verified November 2011
Carboplatin and Eribulin Mesylate in Triple Negative Breast Cancer Patients

Conditions: Estrogen Receptor-negative Breast Cancer; HER2-negative Breast Cancer; Male Breast Cancer; Progesterone Receptor-negative Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Triple-negative Breast Cancer
Interventions: Drug: eribulin mesylate; Drug: carboplatin; Procedure: biopsy
Sponsors: Northwestern University; Northwestern University; Eisai Inc.
Not yet recruiting - verified June 2011