Clinical Trial Information

Mitsubishi Tanabe Pharma Corporation (herein after MTPC) is working to increase transparency in clinical trial information. For details, please click here to access our Clinical Trial Information Disclosure Policy.

This website provides information related to summaries of clinical trial information, clinical trial summary results, clinical trial data to be shared with researchers, publication, and clinical trial data to be shared with patients.

Terms of Use

The information on this web page is not intended to promote or advertise MTPC products, or to recommend off-label or unapproved use of any product.

MTPC will endeavor to update information regularly on all clinical trials listed here. However, please understand that changes in clinical trial results may not always be reflected immediately in the list of summaries of clinical trial information provided on this web page.

Please note: Each individual patient is unique, and information from a specific clinical trial may be more clinically significant for some patients than for others. This clinical significance should be determined by doctors experienced in treating the specific disease that was targeted in the trial, or by other qualified healthcare professionals. If you are a patient or family member and you have any questions about the relevance of clinical trial results to your specific symptoms, please consult your doctor or other appropriate healthcare professional.

1. Registration of Clinical Trial Information and Disclosure of Results

a. Registration of our clinical trial information, and disclosure of results, to clinical trial registries

MTPC will register and disclose information on publicly-accessible clinical trial registries such as ClinicalTrials.gov, jRCT, EU Clinical Trials Register regarding clinical trials that are being conducted or have been conducted. These three registries can be viewed through the links

below:

b. Disclosure of clinical trial summary results

MTPC will disclose summaries of clinical study reports conducted in patients and is also preparing plain language summary that can be easily understood by patients and other non-specialists.

MTPC will disclose the results from clinical trials in patients that form part of the submission package for products initially approved in the United States, Europe, or Japan (in all areas where MTPC intends to obtain marketing approval) in or after January 2018. Results will not be disclosed if MTPC decides that disclosure may lead to identification of clinical trial participants. Results may not be disclosed under any of the following conditions:

  • A third party, such as a company involved in joint development, has not agreed to disclosure.
  • Disclosure may interfere with publication in medical journals.
  • Disclosure may interfere with the protection of intellectual property rights.

c. List of summaries of clinical trial information

Summary of clinical trial information disclosed on ClinicalTrials.gov, and summary results for each clinical trial are provided in the list of summaries of clinical trial information below.
The list does not contain clinical trial information on jRCT that is written in Japanese.

Medical Indication or Disease Phase Information on ClinicalTrials.gov Summary results Summary results in plain language
ClinicalTrials.gov Identifier Study Status
Diffuse Large B-Cell Lymphoma Phase 1, Phase 2 NCT05658562
(Update Nov 2023)
Recruiting
Stable Coronary Artery Disease (CAD), Unstable Angina (Troponin Negative) Phase 4 NCT05740371
(Update Feb 2023)
Completed
Amyotrophic Lateral Sclerosis: ALS Phase 3 NCT05568615
(Update Oct 2023)
Completed
Healthy Adult Males Phase 1 NCT05396235
(Update Jan 2023)
Completed
HTLV-1-Associated Myelopathy (HAM) Phase 1 NCT05240612
(Update Sep 2023)
Active, not recruiting
Systemic Sclerosis Phase 3 NCT05198557
(Update Sep 2023)
Recruiting
Amyotrophic Lateral Sclerosis: ALS Phase 3 NCT05151471
(Update Oct 2023)
Terminated
SARS-CoV-2 Infection
COVID-19
Phase 1, Phase 2 NCT05065619
(Update May 2023)
Terminated
Painful Diabetic Peripheral Neuropathy Phase 2 NCT05123196
(Update Nov 2022)
Completed
Erythropoietic Protoporphyria: EPP, X-Linked Protoporphyria: XLP Phase 3 NCT05005975
(Update Jul 2023)
Active, not recruiting
Healthy Adult Subjects Phase 1 NCT04776135
(Update May 2021)
Completed
Spinal Cord Injury Phase 2 NCT04683848
(Update Sep 2023)
Recruiting
Amyotrophic Lateral Sclerosis: ALS Phase 3 NCT04577404
(Update Oct 2023)
Completed
Amyotrophic Lateral Sclerosis: ALS Phase 3 NCT04569084
(Update Oct 2023)
Terminated
Diffuse Cutaneous Systemic Sclerosis: dcSSc Phase 2 NCT04440592
(Update May 2023)
Active, not recruiting
Erythropoietic Protoporphyria: EPP, X-Linked Protoporphyria: XLP Phase 3 NCT04402489 (Updated May 2023) Completed
Amyotrophic Lateral Sclerosis: ALS Phase 1 NCT04254913 (Update Oct 2020) Completed
Type 2 Diabetes Mellitus Phase 2 NCT00628212 (Update May 2013) Completed
Type 2 Diabetes Mellitus Phase 3 NCT00998881 (Update Feb 2014) Completed
Type 2 Diabetes Mellitus Phase 3 NCT00974090 (Update May 2014) Completed
Type 2 Diabetes Mellitus Phase 3 NCT01026194 (Update Jan 2014) Completed
Type 2 Diabetes Mellitus Phase 3 NCT02314637 (Update Aug 2015) Completed
Type 2 Diabetes Mellitus Phase 3 NCT01072331 (Update Apr 2013) Completed
Type 2 Diabetes Mellitus Phase 3 NCT01301833 (Update Nov 2015) Completed
Type 2 Diabetes Mellitus Phase 4 NCT02081599 (Update Sep 2017) Completed
Type 2 Diabetes Mellitus Phase 3 NCT02916706 (Update Mar 2022) Completed
Type 2 Diabetes Mellitus Phase 3 NCT02924064 (Update Mar 2022) Completed
Type 2 Diabetes Mellitus Phase 2 NCT00971243 (Update Sep 2014) Completed
Acute Ischemic Stroke: AIS Phase 4 NCT00412867 (Update Jan 2018) Completed
Schizophrenia Phase 2 NCT00862992 (Update Apr 2021) Completed
Schizophrenia Phase 3 NCT01625000 (Update Apr 2021) Completed
Schizophrenia Phase 3 NCT01626872 (Update Apr 2021) Completed
Schizophrenia Phase 3 NCT01625897 (Update Apr 2021) Completed
Schizophrenia Phase 3 NCT01626885 (Update Apr 2021) Completed
Schizophrenia Phase 3 NCT01626859 (Update Apr 2021) Completed
Heparin-induced Thrombocytopenia Type II Phase 2 NCT00861692 (Update Aug 2016) Completed
Immunization; Infection in Healthy Infants Phase 3 NCT02992925 (Update Feb 2019) Completed
Immunization; Infection in Healthy Infants Phase 3 NCT03188692 (Update Feb 2019) Completed
Prophylaxis of tetanus, diphtheria, pertussis, poliomyelitis, and bacterial meningitis in Healthy Infants Phase 3 NCT03891758 (Update Nov 2020) Completed
Prophylaxis of diphtheria, tetanus, and pertussis in Healthy Adolescents Phase 3 NCT02118961 (Update Jan 2017) Completed
Multiple Sclerosis Phase 2 NCT00537082 (Update Apr 2011) Completed
Multiple Sclerosis Phase 2 NCT00670449 (Update Sep 2013) Completed
Chronic Hepatitis C Phase 1 NCT00591214 (Update May 2014) Completed
Chronic Hepatitis C Phase 1 NCT00630058 (Update May 2014) Completed
Chronic Hepatitis C Phase 3 NCT00780416 (Update May 2014) Completed
Chronic Hepatitis C Phase 2 NCT00621296 (Update May 2014) Completed
Chronic Hepatitis C Phase 3 NCT00780910 (Update May 2014) Completed
Chronic Hepatitis C Phase 3 NCT00781274 (Update May 2014) Completed
Chronic Hepatitis C Phase 3 NCT01466192 (Update Nov 2014) Completed
Chronic Hepatitis C Phase 3 NCT01468584 (Update Nov 2014) Completed
Chronic Hepatitis C Phase 3 NCT01753557 (Update Oct 2016) Completed
Chronic Hepatitis C Phase 3 NCT01753570 (Update Oct 2018) Completed
Chronic Hepatitis C Phase 1 NCT01766167 (Update Jan 2017) Completed
Chronic Kidney Disease Phase 3 NCT00500682 (Update Jun 2022) Completed
Chronic Kidney Disease Phase 3 NCT00501046 (Update Jun 2022) Completed
Diabetic Polyneuropathy Phase 2 NCT00307749 (Update Dec 2007) Completed
Cerebral Infarction Phase 4 NCT00200356 (Update Jan 2013) Completed
Amyotrophic Lateral Sclerosis: ALS Phase 3 NCT00330681 (Update May 2017) Completed
Amyotrophic Lateral Sclerosis: ALS Phase 3 NCT00424463 (Update Aug 2018) Completed
Amyotrophic Lateral Sclerosis: ALS Phase 3 NCT00415519 (Update Dec 2017) Completed
Amyotrophic Lateral Sclerosis: ALS Phase 3 NCT01492686 (Update Dec 2018) Completed
Acute Ischemic Stroke: AIS Phase 2 NCT03346538 (Update Sep 2018) Terminated
Acute Ischemic Stroke: AIS Phase 2 NCT00821821 (Update May 2014) Completed
Amyotrophic Lateral Sclerosis: ALS Phase 3 NCT04165824 (Update May 2023) Completed
Amyotrophic Lateral Sclerosis: ALS Phase 1 NCT04176224 (Registration Nov 2019) Completed
Type 2 Diabetes Mellitus Phase 2 NCT00497198 (Update Jun 2012) Completed
Chronic Kidney Disease on Dialysis With Hyperphosphatemia Phase 3 NCT00506441 (Update Sep 2014) Completed
Chronic Kidney Disease on Dialysis With Hyperphosphatemia Phase 3 NCT00772382 (Update Sep 2014) Completed
Chronic Kidney Disease With Hyperphosphatemia Phase 3 NCT00416520 (Update Nov 2014) Completed
Chronic Kidney Disease on Dialysis With Hyperphosphatemia and Dyslipidaemia Phase 3 NCT00542386 (Update Oct 2014) Completed
Chronic Kidney Disease on Dialysis With Hyperphosphatemia Phase 3 NCT00451295 (Update Nov 2011) Terminated
Chronic Kidney Disease on Dialysis With Hyperphosphatemia Phase 3 NCT00542815 (Update Oct 2014) Completed
Chronic Kidney Disease on Dialysis Phase 3 NCT00858637 (Update Dec 2014) Completed
Chronic Kidney Disease on Dialysis With Hyperphosphatemia in paediatric subjects Phase 3 NCT01814904 (Update May 2015) Terminated
Chronic Kidney Disease on Dialysis With Hyperphosphatemia in paediatric subjects Phase 3 NCT01814917 (Update May 2015) Terminated
Chronic Kidney Disease Not on Dialysis With Hyperphosphatemia in paediatric subjects Phase 3 NCT01818687 (Update May 2015) Terminated
Cerebral Infarction Phase 3 NCT00129805 (Update Aug 2008) Completed
Cerebral Infarction Phase 3 NCT00147303 (Update Apr 2015) Completed
Rheumatoid Arthritis Phase 2 NCT01143337 (Update Oct 2014) Completed
Inflammatory Bowel Disease Phase 1 NCT01666327 (Update Sep 2014) Completed
Relapsing-remitting Multiple Sclerosis Phase 2 NCT01742052 (Update Sep 2016) Completed
Relapsing-remitting Multiple Sclerosis Phase 2 NCT01890655 (Update Apr 2016) Completed
Plaque Psoriasis Phase 2 NCT01987843 (Update Dec 2014) Completed
Crohn's Disease Phase 2 NCT02378688 (Update Oct 2016) Completed
Crohn's Disease Phase 2 NCT02389790 (Update Sep 2017) Completed
Crohn's Disease Phase 1 NCT02148185 (Update Sep 2014) Completed
Systemic Lupus Erythematosus Phase 1 NCT02307643 (Update Jun 2017) Completed
Prophylaxis of Haemophilus Influenza Type b in healthy infants Phase 2 NCT02140047 (Update Oct 2015) Completed
Type 2 Diabetes Mellitus Phase 3 NCT02220907 (Update Nov 2018) Completed
Type 2 Diabetes Mellitus Phase 3 NCT02354222 (Update Nov 2018) Completed
Type 2 Diabetes Mellitus Phase 3 NCT02354235 (Update Nov 2018) Completed
Endometrial Related Pain Phase 2 NCT03840993 (Update May 2023) Completed
Seasonal Allergic Rhinitis Phase 1 NCT03570957 (Update Jan 2019) Completed
Spinal Cord Injury Phase 1 NCT04096950 (Update May 2023) Completed
Diabetic Nephropathy Phase 2 NCT01756703 (Update Feb 2015) Completed
Diabetic Nephropathy Phase 2 NCT01756716 (Update Feb 2015) Completed
Diabetic Nephropathy Phase 1, Phase 2 NCT01889277 (Update Jan 2015) Completed
Diabetic Nephropathy Phase 1, Phase 2 NCT02205372 (Update Sep 2015) Completed
Diabetic Nephropathy Phase 2 NCT02517320 (Update Mar 2017) Completed
Diabetic Nephropathy Phase 2 NCT02676401 (Update Sep 2017) Completed
Non-Alcoholic Steatohepatitis: NASH Phase 2 NCT02923154 (Update Sep 2019) Completed
Tardive Dyskinesia Phase 2, Phase 3 NCT03176771 (Update Sep 2023) Completed
Osteoarthritis, Knee / Osteoarthritis, Hip Phase 2, Phase 3 NCT03245008 (Update May 2023) Completed
Prophylaxis of Rotavirus Vaccine in Healthy Adults, Toddlers and Infants Phase 1 NCT03507738 (Update Aug 2019) Completed
Anemia; Non-dialysis Dependent Chronic Kidney Disease Phase 3 NCT03329196 (Update Aug 2021) Completed
Anemia; Peritoneal Dialysis Dependent Chronic Kidney Disease Phase 3 NCT03402386 (Update Aug 2021) Completed
Anemia; Hemodialysis Dependent Chronic Kidney Disease Phase 3 NCT03439137 (Update Aug 2021) Completed
Anemia; Hemodialysis Dependent Chronic Kidney Disease Phase 3 NCT03461146 (Update July 2021) Completed
Erythropoietic Protoporphyria: EPP Phase 2 NCT03520036 (Update May 2023) Completed
Menopause Hot Flashes Phase 2 NCT03291067 (Update May 2023) Completed
Vasomotor Symptoms: VMS Phase 2 NCT03541200 (Update May 2023) Completed
Vasomotor Symptoms: VMS Phase 1 NCT02803268 (Update Feb 2017) Completed
Painful Diabetic Peripheral Neuropathy Phase 2 NCT03172598 (Update Aug 2018) Completed
Rheumatoid Arthritis Phase 3 NCT00691028 (Update Mar 2014) Completed
Crohn's Disease Phase 3 NCT00805766 (Update Feb 2018) Completed
Pediatric Crohn's Disease Phase 3 NCT01580670 (Update Jul 2019) Completed
Pediatric Ulcerative Colitis Phase 3 NCT01585155 (Update Nov 2019) Completed
Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin Phase 3 NCT01596335 (Update Oct 2018) Completed
Behcet's Disease, Behcet Syndrome, Neuro-Behcet's Disease Phase 3 NCT01532570 (Update Dec 2016) Completed
Plaque Psoriasis, Psoriatic Arthritis, Pustular Psoriasis (Excluding a Localized), Psoriatic Erythroderma Phase 3 NCT01680159 (Update Mar 2017) Completed
Type 2 Diabetes Mellitus Phase 1, Phase 2 NCT00707954 (Update Apr 2014) Completed
Type 2 Diabetes Mellitus Phase 2 NCT01022112 (Update Jun 2014) Completed
Type 2 Diabetes Mellitus Phase 3 NCT01413204 (Update Jun 2014) Completed
Type 2 Diabetes Mellitus Phase 3 NCT01387737 (Update Jun 2014) Completed
Type 2 Diabetes Mellitus Phase 1 NCT01512849 (Update Jun 2014) Completed
Type 2 Diabetes Mellitus Phase 4 NCT02220920 (Update Dec 2016) Completed
Type 2 Diabetes Mellitus Phase 4 NCT02227849 (Update Apr 2019) Completed
Type 2 Diabetes Mellitus Phase 4 NCT02622113 (Update Apr 2019) Completed
Diabetic Nephropathy Phase 3 NCT03436693 (Update Sep 2021) Completed
Perennial Allergic Rhinitis in Pediatric Patients Phase 3 NCT01425632 (Update Dec 2015) Completed
Perennial Allergic Rhinitis in Pediatric Patients Phase 3 NCT01900054 (Update Apr 2016) Completed
Atopic Dermatitis in Pediatric Patients Phase 3 NCT01840605 (Update May 2018) Completed
Perennial Allergic Rhinitis in Pediatric Patients Phase 3 NCT01861522 (Update Dec 2015) Completed

2. Sharing Clinical Trial Data with Researchers

When requested by a qualified researcher in the field of science or medicine, MTPC will share clinical trial data that was collected from individual patients in a clinical trial with that researcher after a review committee of experts determines that such sharing is appropriate. Such clinical data will always be anonymized before sharing. MTPC will not share data that MTPC feels may place the patient at risk of being identified.

MTPC will share patient data from clinical trials in patients that form part of the submission package for products initially approved in the United States, Europe, or Japan (in all areas where MTPC intends to obtain marketing approval) in or after January 2018. Please use the following link for other conditions and limitations.

https://vivli.org/ourmember/mitsubishi-tanabe-pharma/

Researchers: Please use the link below to request data sharing.

https://vivli.org/

3. Publication of Clinical Trial Results

MTPC in a timely manner, will endeavor to provide relevant presentations at scientific meetings, or publications in scientific journals, of the clinical trial results where results are considered to be of significant medical importance. When such an article is published, MTPC will cite the publication on publicly accessible clinical trial registries.

4. Sharing Clinical Trial Results with Patients Who Participate in Clinical Trials

MTPC plans to share personal patient results from clinical trials individually with each clinical trial participant. This information-sharing program is currently in the planning stages.

Questions

If you have any questions about disclosure of clinical trial information, please email us:

MTPC-CTDS-office@cc.mt-pharma.co.jp

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