Clinical trials: sponsored by Daiichi Sankyo
Duchenne Muscular Dystrophy
Long-term, Extension Study of DS-5141b in Patients With Duchenne Muscular Dystrophy
This is a multicenter, open-label, long-term, extension, phase 2 study to evaluate the safety and efficacy of long-term treatment with DS-5141b in patients with DMD who have completed DS5141-A-J101.
- Trial name
- NCT04433234
- Testing
- DS-5141b
- Where
- 2 sites in Japan
- Volunteers
- 8 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Acute Myeloid Leukemia
Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood
Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research. Children or young adults with a certain kind of blood cancer (FLT3-ITD AML) might be able to join this study if it…
- Trial name
- NCT03793478
- Testing
- Quizartinib, Fludarabine, Cytarabine
- Where
- 27 sites in United States, Belgium and 8 more
- Volunteers
- 65 people
- Sponsor
- Daiichi Sankyo
Venous Thromboembolism (VTE), Pulmonary Embolism
Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)
This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint evaluation (PROBE) parallel group study in subjects with confirmed VTE.
- Conditions
- Venous Thromboembolism (VTE), Pulmonary Embolism, Deep Vein Thrombosis (DVT)
- Trial name
- NCT02798471
- Testing
- Edoxaban, Standard of Care
- Where
- 140 sites in United States, Argentina and 32 more
- Volunteers
- 290 people
- Sponsor
- Daiichi Sankyo
Duchenne Muscular Dystrophy
Study of DS-5141b in Patients With Duchenne Muscular Dystrophy
This is a phase I/II study to evaluate the safety, tolerability, efficacy, and pharmacokinetic (PK) profile of DS-5141b in patients with Duchenne muscular dystrophy (DMD) amenable to exon 45 skipping and to determine the dosage…
- Trial name
- NCT02667483
- Testing
- DS-5141b
- Where
- 2 sites in Japan
- Volunteers
- 8 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Deep Vein Thrombosis, Venous Thromboembolism
Phase 1 Pediatric Pharmacokinetics/Pharmacodynamics (PK/PD) Study
This is the first evaluation of edoxaban in pediatric subjects. In this Phase 1 study, a single dose of edoxaban will be given to pediatric subjects who require anticoagulant therapy to see what the body does to the drug…
- Trial name
- NCT02303431
- Testing
- Edoxaban low dose, Edoxaban high dose
- Where
- 35 sites in United States, Canada and 7 more
- Volunteers
- 66 people
- Sponsor
- Daiichi Sankyo
Hypercholesterolemia, Mixed Dyslipidemia
SurveY Followed by a Retrospective Chart Review to Describe the Key Factors Leading to Physician's Decision to Treat Patients at High and Very High Cardiovascular Risk With hyperchOlesterolemia or Mixed Dyslipidemia With NUSTENDI®
In this study, a survey of office-based cardiologists and lipid management specialists will be conducted on treatment decisions for NUSTENDI® (bempedoic acid 180 mg fixed dose combination [FDC] with ezetimibe 10 mg) followed by a…
- Trial name
- NCT05546398
- Testing
- Bempedoic Acid 180Mg/Ezetimibe 10Mg Tab, No study drug
- Where
- 63 sites in Germany
- Volunteers
- 500 people
- Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Cardiac Disease
Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease
A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care). All children in the study will receive free treatment.
- Trial name
- NCT03395639
- Testing
- Edoxaban, Standard of Care (SOC)
- Where
- 48 sites in United States, Austria and 12 more
- Volunteers
- 168 people
- Sponsor
- Daiichi Sankyo
Type 2 Diabetes Mellitus
Colesevelam for Children With Type 2 Diabetes
This study will evaluate the efficacy and safety of the study drug in treating type 2 diabetes in children 10 to 17 years old. The groups will be low-dose (0.625 g Welchol) and high-dose (3.75 g Welchol).
- Trial name
- WELKid DM (NCT01258075)
- Testing
- High-dose colesevelam, Low-dose colesevelam
- Where
- 24 sites in United States
- Volunteers
- 236 people
- Sponsor
- Daiichi Sankyo
Non-CNS Germ Cell Tumors (Seminomas and Nonseminomas)
ARQ 197 for Participants With Relapsed or Refractory Germ Cell Tumors
This is a multicenter, single-arm study for safety and efficacy.
- Trial name
- NCT01055067
- Testing
- Tivantinib (ARQ 197)
- Where
- 10 sites in United States, France and 1 more
- Volunteers
- 27 people
- Sponsor
- Daiichi Sankyo
Baseline Epidemiologic Assessment
Baseline Epidemiologic Assessment of Abuse-Deterrence of MorphaBond Extended Release (BEAD-MB)
The main objectives of this study are to provide surveillance/descriptive data to (a) assess utilization of MorphaBond ER and selected comparators overall and by age group and census regions using nationally-projected quarterly…
- Trial name
- BEAD-MB (NCT04033094)
- Testing
- MorphaBond ER, Comparator Drug
- Where
- United States
- Volunteers
- 17,566 people
- Sponsor
- Daiichi Sankyo
Acute Spinal Cord Injury
Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SUN13837 Injection in Adult Subjects With Acute Spinal Cord Injury (ASCI)
The purpose of this research study is to gather scientific information about the effectiveness of the study drug, SUN13837 Injection, when compared with the placebo (inactive substance) in participants with acute spinal cord…
- Trial name
- NCT01502631
- Testing
- SUN13837 injection
- Where
- 67 sites in United States, Canada and 5 more
- Volunteers
- 65 people
- Sponsor
- Daiichi Sankyo
Advanced Cancer
Extended Use Protocol for Participants With Cancer to Receive Continued Treatment With CS-7017
This is a study of CS-7017 designed to allow participants who completed participation in a clinical study of CS-7017 without experiencing disease progression or unacceptable toxicity to continue treatment with study drug.
- Trial name
- NCT00881569
- Testing
- CS-7017
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Daiichi Sankyo
Metastatic Colorectal Cancer
An Observational Study of CPT-11 Based Regimens and UGT1A1 Genotypes in Metastatic Colorectal Cancer (mCRC)
The purpose of this study is to examine the correlation between UGT1A1 genotypes and the efficacy of CPT-11 based regimens (FOLFIRI, CPT-11+S-1, CPT-11) for patients with metastatic colorectal cancer.
- Trial name
- NCT01039506
- Testing
- CPT-11 based regimens
- Where
- Japan
- Volunteers
- 1,376 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Small Cell Lung Cancer, Non-small Cell Lung Cancer
An Observational Study of CPT-11 Plus Platinum Analogues Regimens and UGT1A1 Genotypes in Solid Tumors
The purpose of this study is to examine the correlation between UGT1A1 genotypes and the safety of CPT-11 plus platinum analogues (cisplatin, carboplatin and nedaplatin) regimens for patients with lung cancer, cervical cancer…
- Conditions
- Small Cell Lung Cancer, Non-small Cell Lung Cancer, Cervical Cancer, Ovarian Cancer
- Trial name
- NCT01040312
- Testing
- CPT-11, Platinum analogues
- Where
- Japan
- Volunteers
- 321 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Hypertension
Assessment of Efficacy and Safety of Olmesartan Medoxomil in Children and Adolescent Patients With High Blood Pressure
This study assesses the efficacy and safety of olmesartan medoxomil in children ages 1-16 with high blood pressure. After a 5-week blinded treatment period of up to 5 weeks participants can continue to take olmesartan medoxomil…
- Trial name
- NCT00151775
- Testing
- olmesartan medoxomil
- Where
- 65 sites in United States, Argentina and 9 more
- Volunteers
- 362 people
- Sponsor
- Daiichi Sankyo
Sarcoma
Soblidotin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma
RATIONALE: Drugs used in chemotherapy such as soblidotin use different ways to stop tumor cells from dividing so they stop growing or die.
- Trial name
- NCT00064220
- Testing
- soblidotin
- Where
- 6 sites in United States, Puerto Rico
- Sponsor
- Daiichi Sankyo
Liver Cancer
DX-8951f in Treating Patients With Liver Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have liver cancer.
- Trial name
- NCT00004108
- Testing
- exatecan mesylate
- Where
- 4 sites in United States
- Sponsor
- Daiichi Sankyo
Sarcoma
Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating children who have…
- Trial name
- NCT00055939
- Testing
- exatecan mesylate
- Where
- 9 sites in United States, Canada
- Sponsor
- Daiichi Sankyo
Sarcoma
Exatecan Mesylate in Treating Patients With Ewing's Sarcoma, Primitive Neuroectodermal Tumor, or Desmoplastic Small Round Cell Tumor
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients who have…
- Trial name
- NCT00055952
- Testing
- exatecan mesylate
- Where
- 9 sites in United States, Canada
- Sponsor
- Daiichi Sankyo
Extrahepatic Bile Duct Cancer, Gallbladder Cancer
DX-8951f in Treating Patients With Biliary Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have biliary cancer.
- Conditions
- Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer
- Trial name
- NCT00005938
- Testing
- exatecan mesylate
- Where
- 5 sites in United States
- Sponsor
- Daiichi Sankyo