Clinical trials: sponsored by Eisai Inc.
Unresectable Stage III, Stage IV Melanoma
An Open-Label, 2-Cohort, Multicenter, Study of Lenvatinib in Previously Treated Subjects With Unresectable Stage III or Stage IV Melanoma
The purpose of this study is to assess the objective response rate of lenvatinib in previously treated participants with American Joint Committee on Cancer (AJCC) unresectable Stage III or Stage IV melanoma and disease…
- Trial name
- NCT01136967
- Testing
- Lenvatinib
- Where
- 95 sites in United States, Australia and 2 more
- Volunteers
- 182 people
- Sponsor
- Eisai Inc.
Thyroid Carcinoma, Anaplastic
A Phase 2 Trial of Lenvatinib for the Treatment of Anaplastic Thyroid Cancer (ATC)
The primary purpose of the study is to evaluate objective response rate ([ORR]: complete response [CR] and partial response [PR]) by investigator review in participants with anaplastic thyroid cancer (ATC) treated with lenvatinib.
- Trial name
- NCT02657369
- Testing
- Lenvatinib 24 mg
- Where
- 30 sites in United States, Australia and 3 more
- Volunteers
- 34 people
- Sponsor
- Eisai Inc.
Obesity
BLOSSOM: Behavioral Modification and Lorcaserin Second Study for Obesity Management
The purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients.
- Trial name
- NCT00603902
- Testing
- Lorcaserin 10 mg once daily (QD), Lorcaserin 10 mg twice a day (BID)
- Where
- United States
- Volunteers
- 4,008 people
- Sponsor
- Eisai Inc.
Obesity
BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management
The purpose of this study is to assess the weight loss effect of lorcaserin at the end of the first year of treatment (Week 52) and to assess the ability of lorcaserin to maintain weight loss at the end of the second year of…
- Trial name
- NCT00395135
- Testing
- Lorcaserin 10 mg BID
- Where
- United States
- Volunteers
- 3,182 people
- Sponsor
- Eisai Inc.
Obesity
BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus
The purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients with Type II diabetes mellitus treated with metformin, sulfonylurea (SFU)…
- Trial name
- NCT00603291
- Testing
- Lorcaserin 10 mg once daily (QD), Lorcaserin 10 mg twice a day (BID)
- Where
- United States
- Volunteers
- 604 people
- Sponsor
- Eisai Inc.
Chronic Weight Management
A Multicenter, Double-blind, Randomized, Parallel-group, Pilot Study of 12-week Duration to Assess the Short-term Safety and Tolerability of Lorcaserin Plus Two Doses of Immediate-Release Phentermine-HCl Compared With Lorcaserin Alone in Overweight and Obese Adults
APD356-A001-402 is a multicenter, double-blind, randomized, parallel-group pilot study of 12-week duration in overweight and obese adults.
- Trial name
- NCT01987427
- Testing
- lorcaserin + phentermine-HCl
- Where
- 13 sites in United States
- Volunteers
- 344 people
- Sponsor
- Eisai Inc.
Pharmacokinetics in Obese Adolescents
Single Dose Study to Determine the Safety, Tolerability, and Pharmacokinetic Properties of Lorcaserin Hydrochloride (BELVIQ) in Obese Adolescents From 12 to 17 Years of Age
The purpose of this study is to evaluate the PK properties, tolerability, and safety of lorcaserin HCL (BELVIQ) in obese adolescent subjects between the ages of 12 to 17 years old
- Trial name
- NCT02022956
- Testing
- Lorcaserin
- Where
- 2 sites in United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Obesity
Safety and Efficacy of APD356 in the Treatment of Obesity
This is a research study of an investigational drug, APD356, a novel, selective 5-HT2c receptor agonist, in clinical development as a potential treatment for obesity.
- Trial name
- NCT00116740
- Testing
- APD356
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Hepatic Impairment
Pharmacokinetic Properties of Lorcaserin in Subjects With Hepatic Impairment
The purpose of this study is to evaluate and establish whether lorcaserin dose adjustment is required in patients with mild or moderate hepatic impairment.
- Trial name
- NCT00828932
- Testing
- Lorcaserin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Obesity
Safety and Efficacy of APD356 in the Treatment of Obesity
This is a research study of an investigational drug, APD356, a novel, selective 5-HT2c receptor agonist, in clinical development as a potential treatment for obesity.
- Trial name
- NCT00104507
- Testing
- APD356
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Obesity
To Assess the Effect of Lorcaserin Hydrochloride on Energy Metabolism and Food Intake
The purpose of this study is to evaluate the effect of lorcaserin on energy metabolism and food intake in obese and overweight patients.
- Trial name
- TULIP (NCT00829140)
- Testing
- Lorcaserin 10mg BID
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Eisai Inc.
Renal Impairment
Pharmacokinetic Properties of Lorcaserin in Subjects With Renal Impairment
The purpose of this study is to evaluate the PK properties of lorcaserin in subjects with end stage renal disease (ESRD) who require dialysis and will be studied under dialysis and non-dialysis conditions.
- Trial name
- NCT00828438
- Testing
- Lorcaserin 10mg
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Obesity
Pharmacokinetic Properties of Lorcaserin in the Fed and Fasted State
The purpose of this study is to evaluate the PK properties in fed and fasted men and women.
- Trial name
- NCT00828724
- Testing
- Lorcaserin 10mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Drug Abuse, Healthy
Abuse Potential of Single Doses of Lorcaserin in Healthy Recreational Polydrug Users
The purpose of this study is to evaluate the abuse potential of lorcaserin in healthy recreational polydrug users.
- Trial name
- NCT00828659
- Testing
- Active Comparator #1, Active Comparator #2, Active Comparator #3
- Where
- Canada
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Acute Myeloid Leukemia
Trial of Decitabine in Patients With Acute Myeloid Leukemia
The purpose of this study is to compare the results in older patients who have newly diagnosed or secondary acute myeloid leukemia (AML) and who are to either receive decitabine or patient's choice with the physician's advice of…
- Trial name
- NCT00260832
- Testing
- Cytarabine or Supportive Care, Dacogen (decitabine) only
- Where
- 108 sites in United States, Australia and 13 more
- Volunteers
- 485 people
- Sponsor
- Eisai Inc.
Tumors
Phase 1 Study to Determine the Effect of Lenvatinib (E7080) on the Pharmacokinetics of Midazolam in Subjects With Advanced Solid Tumors
This is a multicenter, open-label, non-randomized Phase 1 study in participants with advanced solid tumors, excluding hepatocellular carcinoma (HCC), that have progressed after treatment with approved therapies, or for which…
- Trial name
- NCT02686164
- Testing
- Lenvatinib, Midazolam
- Where
- 4 sites in United States
- Volunteers
- 51 people
- Sponsor
- Eisai Inc.
HER2-normal
Dose Dense Doxorubucin and Cyclophosphamide Followed by Eribulin Mesylate for the Adjuvant Treatment of Early Stage Breast Cancer
The purpose of this study is to assess the feasibility of dose-dense doxorubicin and cyclophosphamide followed by eribulin mesylate for adjuvant treatment of early stage breast cancer.
- Trial name
- NCT01328249
- Testing
- eribulin mesylate
- Where
- 2 sites in United States
- Volunteers
- 81 people
- Sponsor
- Eisai Inc.
KIF5B-RET-Positive Adenocarcinoma of the Lung
Study of the Safety and Activity of Lenvatinib (E7080) in Subjects With KIF5B-RET-Positive Adenocarcinoma of the Lung
This is a Phase 2, open-label, safety and activity study of lenvatinib in subjects with KIF5B-RET-positive adenocarcinoma of the lung and other confirmed RET translocations.
- Trial name
- NCT01877083
- Testing
- Lenvatinib
- Where
- 23 sites in United States, Hong Kong and 3 more
- Volunteers
- 25 people
- Sponsor
- Eisai Inc.
Lennox-Gastaut Syndrome
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
This study was designed to evaluate the cognitive effect, safety, and pharmacokinetics (PK) of rufinamide on Lennox-Gastaut Syndrome (LGS) inadequately controlled in pediatric participants already taking other anti-epileptic…
- Trial name
- NCT01405053
- Testing
- Rufinamide, Any other approved Antiepileptic Drug
- Where
- 47 sites in United States, Canada and 5 more
- Volunteers
- 37 people
- Sponsor
- Eisai Inc.
Healthy Subjects
Crossover Study to Evaluate the Effect of Lemborexant Versus Placebo and Zolpidem on Postural Stability, Auditory Awakening Threshold, and Cognitive Performance in Healthy Subjects 55 Years and Older
E2006-A001-108 is a 4-period crossover study designed to demonstrate that the mean change from baseline in postural stability (worsening) when participants are awakened at approximately 4 hours postdose is significantly less…
- Trial name
- NCT03008447
- Testing
- LEM5, LEM10, ZOL
- Where
- 4 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.