臨床試験情報

田辺三菱製薬(以下、当社)は、臨床試験に関する情報の透明性を向上させることに取り組んでいます。詳しくは、臨床試験情報の開示に関するポリシーを、こちらからご覧ください。

本ページでは、当社が実施する臨床試験の概要・結果、研究者とのデータの共有、パブリケーション、ならびに、患者さんへの結果の共有に関する情報を提供いたします。

利用規約

本ページの情報は、当社の医薬品の宣伝・広告を目的とするものではありません。また、適応症以外での使用や、未だ承認されていない使用方法を推奨することを目的とするものでもありません。

当社はここに掲載する全ての臨床試験に関して、最新の情報を提供するよう努めます。ただし、臨床試験結果は変更となることがあり、また、その変更が本ページの臨床試験の概要一覧に反映されない場合がありますのでご了承ください。

なお、臨床試験結果にかかわる情報が、患者さん一人ひとりにとって臨床的にどのような意義を有するかは、その病気の治療経験をお持ちの医師または適切な医療関係者の判断となります。そのため、個別の症状との関わりについてご質問がある場合は、医師または適切な医療関係者にご相談ください。

1. 臨床試験情報の登録と結果の公開

a. 臨床試験情報登録サイトへの情報の登録と結果の公開

当社は、当社が実施中あるいは実施した臨床試験の情報を、ClinicalTrials.gov、JapicCTI、EU Clinical Trials Registerなどの一般に公開されている臨床試験情報登録サイトに登録・公開しています。上記3つの登録サイトは、以下のリンクからご確認いただけます。

リンク

b. 臨床試験の結果概要の公開

当社は、患者さんを対象とした臨床試験の総括報告書の概要を公開します。さらに、研究者以外の方に向けた、分かりやすい結果のまとめを公開します。

対象は、2018年1月以降に初めて、米国、欧州及び日本のうち、承認を目指す全ての地域で承認を取得した製品の承認申請に用いた患者さんを対象とした臨床試験の結果です。ただし、当社において患者さんが特定されるリスクがあると判断した場合には公開しません。また、以下の場合には、公開しないこともあります。

  • 共同開発会社等の第三者との間で、公開の合意が得られていない場合
  • 医学雑誌への発表に支障をきたす場合
  • 知的財産の権利を保護する必要がある場合

分かりやすい結果のまとめは、現在準備中です。

c. 臨床試験の概要一覧

当社は、当社がClinicalTrials.gov、JapicCTIに登録・公開している臨床試験の情報、ならびに、臨床試験の結果概要を「臨床試験の概要一覧」に掲載しています。JapicCTIに登録・公開している試験は、こちらから、「臨床試験情報の検索・閲覧」を選択し、JapicCTI番号を入力して検索し、閲覧してください。

治験コード
(一般名)
試験No. 試験の名称
(日本語・英語)
対象疾患
(日本語・英語)
臨床試験情報登録サイトに公開している情報 結果概要 分かりやすい結果のまとめ
ClinicalTrials.gov
(英語)
JapicCTI
(日本語)
試験の状況
MT-1186
(Edaravone)
(エダラボン)
MT-1186-A03 Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS) ALS NCT04577404(Registration Oct 2020) - Not yet recruiting
MT-1186
(Edaravone)
(エダラボン)
MT-1186-A02 Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS ALS NCT04569084(Registration Sep 2020) - Not yet recruiting
MT-7117
(Dersimelagon)
MT-7117-G02 Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis Diffuse Cutaneous Systemic Sclerosis NCT04440592(Update Aug 2020) - Not yet recruiting
MT-7117
(Dersimelagon)
MT-7117-G01 Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Erythropoetic Protoporphyria or X-Linked Protoporphyria
赤芽球性プロトポルフィリン症(EPP)又はX連鎖性プロトポルフィリン症(XLP)の成人患者及び青年患者を対象としてMT-7117の有効性,安全性及び忍容性を評価する第3相,多施設共同,無作為化,二重盲検プラセボ対照試験
EPP, XLP
赤芽球性プロトポルフィリン症又はX連鎖性プロトポルフィリン症
NCT04402489 (Update Sep 2020) JapicCTI-205451
(更新日 2020年10月)
Recruiting
実施中
MT-1186
(Edaravone)
(エダラボン)
MT-1186-J05 Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With Gastrostomy
胃瘻を造設した筋萎縮性側索硬化症患者を対象としたエダラボンの臨床薬理試験
Japanese Patients With ALS
筋萎縮性側索硬化症
NCT04254913 (Update Oct 2020) JapicCTI-205129
(更新日 2020年9月)
Completed
試験完了
MP-513
(Teneligliptin)
(テネリグリプチン臭化水素酸塩水和物)
3000-A4 Efficacy and Safety Study of MP-513 in Patients With Type 2 Diabetes Type 2 Diabetes NCT00628212 (Update May 2013) - Completed
MP-513
(Teneligliptin)
(テネリグリプチン臭化水素酸塩水和物)
3000-A5 Monotherapy Study of MP-513 in Patients With Type 2 Diabetes Type 2 Diabetes Mellitus NCT00998881 (Update Feb 2014) - Completed
MP-513
(Teneligliptin)
(テネリグリプチン臭化水素酸塩水和物)
3000-A6 Efficacy and Safety Study of MP-513 in Combination With Sulfonylurea in Patients With Type 2 Diabetes Type 2 Diabetes Mellitus NCT00974090 (Update May 2014) - Completed
MP-513
(Teneligliptin)
(テネリグリプチン臭化水素酸塩水和物)
3000-A7 Efficacy and Safety Study of MP-513 in Combination With Thiazolidinedione in Patients With Type 2 Diabetes Type 2 Diabetes Mellitus NCT01026194 (Update Jan 2014) - Completed
MP-513
(Teneligliptin)
(テネリグリプチン臭化水素酸塩水和物)
3000-A8 Long-term Safety Study of MP-513 as Monotherapy or in Combination With Sulfonylurea in Japanese Type 2 Diabetic Patients Type 2 Diabetes Mellitus NCT02314637 (Update Aug 2015) - Completed
MP-513
(Teneligliptin)
(テネリグリプチン臭化水素酸塩水和物)
3000-A12 Pharmacokinetic/Pharmacodynamic Study of MP-513 With Type 2 Diabetes Mellitus Type 2 Diabetes Mellitus NCT01072331 (Update Apr 2013) - Completed
MP-513
(Teneligliptin)
(テネリグリプチン臭化水素酸塩水和物)
3000-A14 Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes Type 2 Diabetes Mellitus NCT01301833 (Update Nov 2015) - Completed
MP-513
(Teneligliptin)
(テネリグリプチン臭化水素酸塩水和物)
3000-A15 Efficacy and Safety Study of Teneligliptin (MP-513) in Combination With Insulin in Patients With Type 2 Diabetes Type 2 Diabetes Mellitus NCT02081599 (Update Sep 2017) - Completed
MP-513
(Teneligliptin)
(テネリグリプチン臭化水素酸塩水和物)
MP-513-C02 Efficacy and Safety of Teneligliptin in Chinese Patients With Type 2 Diabetes Mellitus Type 2 Diabetes Mellitus NCT02916706 (Update Nov 2018) - Completed
MP-513
(Teneligliptin)
(テネリグリプチン臭化水素酸塩水和物)
MP-513-C03 Efficacy and Safety of Teneligliptin in Combination With Metformin in Chinese Patients With Type 2 Diabetes Mellitus Type 2 Diabetes Mellitus NCT02924064 (Update Nov 2018) - Completed
MP-513
(Teneligliptin)
(テネリグリプチン臭化水素酸塩水和物)
MP-513-E07 Efficacy and Safety of MP-513 in Combination With Metformin in Patients With Type 2 Diabetes Type 2 Diabetes Mellitus NCT00971243 (Update Sep 2014) - Completed
GMK-527
(Alteplase〔genetical recombination〕)
(アルテプラーゼ
〔遺伝子組換え〕)
527-0611 Post-marketing Clinical Study of Alteplase for Acute Ischemic Stroke (Japan Alteplase Clinical Trial Ⅱ:J-ACT Ⅱ)
アルテプラーゼの虚血性脳血管障害急性期に対する製造販売後臨床試験
Stroke
虚血性脳血管障害急性期
NCT00412867 (Update Jan 2018) JapicCTI-060339
(更新日 2016年1月)
Completed
試験完了
MP-214
(Cariprazine)
(カリプラジン塩酸塩)
A002-A3 Safety, Pharmacokinetics and Efficacy Study of MP-214 in Patients With Schizophrenia Schizophrenia NCT00862992 (Update Sep 2009) - Completed
MP-214
(Cariprazine)
(カリプラジン塩酸塩)
A002-A4 Safety and Efficacy of MP-214 in Patients With Schizophrenia Schizophrenia NCT01625000 (Update Sep 2016) - Completed
MP-214
(Cariprazine)
(カリプラジン塩酸塩)
A002-A5 Long-Term Study of MP-214 in Patients With Schizophrenia Schizophrenia NCT01626872 (Update Apr 2017) - Completed
MP-214
(Cariprazine)
(カリプラジン塩酸塩)
A002-A7 A Long-Term Study of MP-214 in Patients With Chronic Phase or Elderly Schizophrenia Schizophrenia NCT01625897 (Update Apr 2015) - Completed
MP-214
(Cariprazine)
(カリプラジン塩酸塩)
A002-A8 A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia Schizophrenia NCT01626885 (Update Jan 2015) - Completed
MP-214
(Cariprazine)
(カリプラジン塩酸塩)
A002-A11 A Pharmacokinetic Study of MP-214 in Patients With Schizophrenia Schizophrenia NCT01626859 (Update Jun 2014) - Completed
MCI-9038
(Argatroban)
(アルガトロバン)
ARG-E07 Clinical Management of Argatroban in Patients With Heparin Induced Thrombocytopenia Type II Heparin-induced Thrombocytopenia Type II NCT00861692 (Update Aug 2016) - Completed
BK1310 BK1310-J01 Phase 3 Study of BK1310 in Healthy Infants Immunization; Infection NCT02992925 (Update Feb 2019) - Completed
BK1310 BK1310-J02 Safety and Efficacy of BK1310 Intramuscular Injection in Healthy Infants Immunization NCT03188692 (Update Feb 2019) - Completed
BK1310 BK1310-J03 Confirmatory Study of BK1310 in Healthy Infants
健康乳幼児におけるアクトヒブ及びテトラビックを比較対照としたBK1310のランダム化,評価者盲検,実薬対照の第3相試験
Tetanus|Diphtheria|Pertussis|Poliomyelitis|Bacterial Meningitis
百日せき,ジフテリア,破傷風,急性灰白髄炎及びHib(インフルエンザ菌b型)による侵襲性感染症の予防
NCT03891758 (Update May 2020) JapicCTI-194682
(更新日 2020年5月)
Active, not recruiting
実施中(参加募集終了)
BK-4SP BK-4SP Confirmatory study of BK-4SP in healthy infants
BK-4SPの健康小児を対象とした検証的試験
Prophylaxis of pertussis, diphtheria, tetanus, and poliomyelitis infection
百日せき、ジフテリア、破傷風及び急性灰白随炎の予防
- JapicCTI-101124
(更新日 2017年5月)
Completed
試験完了
BK1301 BKD1A Study of BK1301 (DTaP Vaccine) as a Booster in Adolescents Diphtheria|Tetanus|Pertussis NCT02118961 (Update Jan 2017) - Completed
FTY720
(Fingolimod hydrochloride)
(フィンゴリモド塩酸塩)
CFTY720D1201 Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis (MS)
FTY720の多発性硬化症患者を対象とした第2相臨床試験
Multiple Sclerosis
再発性多発性硬化症
NCT00537082 (Update Apr 2011) JapicCTI-070462
(更新日 2012年6月)
Completed
試験完了
FTY720
(Fingolimod hydrochloride)
(フィンゴリモド塩酸塩)
CFTY720D1201E1 An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple Sclerosis
FTY720の多発性硬化症患者を対象とした第2相臨床試験の継続投与試験
Multiple Sclerosis
再発性多発性硬化症
NCT00670449 (Update Sep 2013) JapicCTI-080575
(更新日 2015年4月)
Completed
試験完了
MP-424
(Telaprevir)
(テラプレビル)
G060-A3 Safety and PK Study of MP-424 to Treat Chronic Hepatitis C
C型慢性肝炎を対象としたMP-424の臨床薬理試験 (第1相:反復投与試験)
Chronic Hepatitis C
C型慢性肝炎
NCT00591214 (Update May 2014) JapicCTI-080511
(更新日 2015年10月)
Completed
試験完了
MP-424
(Telaprevir)
(テラプレビル)
G060-A5 A Phase 1 Study of MP-424, Peginterferon Alfa 2b, and Ribavirin in Hepatitis C
C型慢性肝炎を対象としたMP-424の臨床薬理試験 ペグインターフェロンアルファ-2b(遺伝子組換え)及びリバビリンとの併用試験(第1相:反復投与試験)
Hepatitis C
C型慢性肝炎
NCT00630058 (Update May 2014) JapicCTI-080538
(更新日 2015年10月)
Completed
試験完了
MP-424
(Telaprevir)
(テラプレビル)
G060-A6 Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naive Patients With Chronic Hepatitis C
C型慢性肝炎(初回治療例)を対象としたMP-424の検証的試験 ペグインターフェロンアルファ-2b(遺伝子組換え)及びリバビリンとの併用試験
Hepatitis C
C型慢性肝炎
NCT00780416 (Update May 2014) JapicCTI-080639
(更新日 2015年10月)
Completed
試験完了
MP-424
(Telaprevir)
(テラプレビル)
G060-A7 Safety and Efficacy of MP-424 to Treat Chronic Hepatitis C
C型慢性肝炎を対象としたMP-424の探索的試験(第2相)
Hepatitis C
C型慢性肝炎
NCT00621296 (Update May 2014) JapicCTI-080532
(更新日 2015年10月)
Completed
試験完了
MP-424
(Telaprevir)
(テラプレビル)
G060-A8 Efficacy and Safety of MP-424, Peginterferon Alfa-2b, and Ribavirin in Patients With Chronic Hepatitis C Who Relapsed After Previous Interferon Based Therapy
C型慢性肝炎(前治療後再燃例)を対象としたMP-424の臨床試験 ペグインターフェロンアルファ-2b(遺伝子組換え)及びリバビリンとの併用試験
Chronic Hepatitis C
C型慢性肝炎
NCT00780910 (Update May 2014) JapicCTI-080641
(更新日 2015年10月)
Completed
試験完了
MP-424
(Telaprevir)
(テラプレビル)
G060-A9 Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Chronic Hepatitis C Who Have Not Achieved an Undetectable HCV RNA Level With Previous Interferon Based Therapy
C型慢性肝炎(前治療無効例)を対象としたMP-424の臨床試験 ペグインターフェロンアルファ-2b(遺伝子組換え)及びリバビリンとの併用試験
Hepatitis C
C型慢性肝炎
NCT00781274 (Update May 2014) JapicCTI-080642
(更新日 2015年10月)
Completed
試験完了
MP-424
(Telaprevir)
(テラプレビル)
G060-A10 Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Relapser Genotype 2 Hepatitis C Infected Patients Chronic Hepatitis C NCT01466192 (Update Nov 2014) - Completed
MP-424
(Telaprevir)
(テラプレビル)
G060-A11 Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Non-responder Genotype 2 Hepatitis C Infected Patients Chronic Hepatitis C NCT01468584 (Update Nov 2014) - Completed
MP-424
(Telaprevir)
(テラプレビル)
G060-A12 Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naive or Relapsed Hepatitis C Chronic Hepatitis C (CHC) NCT01753557 (Update Oct 2016) - Completed
MP-424
(Telaprevir)
(テラプレビル)
G060-F1 Efficacy and Safety of MP-424, Interferon Beta (IFN Beta), and Ribavirin(RBV) in Treatment-Naive or Having Received Interferon Based Therapy With Chronic Hepatitis C (CHC) Chronic Hepatitis C(CHC) NCT01753570 (Update Oct 2018) - Completed
MP-424
(Telaprevir)
(テラプレビル)
MP-424-K01 Clinical Pharmacology Study of MP-424 Chronic Hepatitis C NCT01766167 (Update Jan 2017) - Completed
MP-146 KRM-306 A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease (EPPIC-1) Chronic Kidney Disease NCT00500682 (Update Mar 2015) - Completed
MP-146 KRM-307 A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease Including Assessment of Quality of Life (EPPIC-2) Chronic Kidney Disease NCT00501046 (Update Mar 2015) - Completed
MCC-257 MCC-257-A03 Safety and Efficacy of MCC-257 in the Treatment of Diabetic Polyneuropathy Diabetic Polyneuropathy NCT00307749 (Update Dec 2007) - Completed
MCI-186
(Edaravone)
(エダラボン)
MCI186-13 Edaravone-Sodium Ozagrel Comparative Post-Marketing Study on Acute Ischemic Stroke
エダラボンの脳血栓症急性期に対する市販後臨床試験
Cerebral Infarction
脳血栓症急性期
NCT00200356 (Update Jan 2013) JapicCTI-050129
(更新日 2016年4月)
Completed
試験完了
MCI-186
(Edaravone)
(エダラボン)
MCI186-16 Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS)
筋萎縮性側索硬化症を対象としたMCI-186の二重盲検並行群間比較法による検証的試験
Amyotrophic Lateral Sclerosis (ALS)
筋萎縮性側索硬化症(ALS)
NCT00330681 (Update May 2017) JapicCTI-060256
(更新日 2016年10月)
Completed
試験完了
MCI-186
(Edaravone)
(エダラボン)
MCI186-17 Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis (ALS) NCT00424463 (Update Aug 2018) - Completed
MCI-186
(Edaravone)
(エダラボン)
MCI186-18 Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) Who Met Severity Classification III Amyotrophic Lateral Sclerosis (ALS) NCT00415519 (Update Dec 2017) - Completed
MCI-186
(Edaravone)
(エダラボン)
MCI186-19 Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis (ALS) NCT01492686 (Update Dec 2018) - Completed
MCI-186
(Edaravone)
(エダラボン)
MCI-186-J20 Dose Finding Study of MCI-186 in Acute Ischemic Stroke Acute Ischemic Stroke NCT03346538 (Update Sep 2018) - Terminated
MCI-186
(Edaravone)
(エダラボン)
MCI-186-E04 Safety and Pharmacokinetics of MCI-186 in Subjects With Acute Ischemic Stroke Acute Ischemic Stroke (AIS) NCT00821821 (Update May 2014) - Completed
MT-1186
(Edaravone)
(エダラボン)
MT-1186-A01 Safety Study of Oral Edaravone Administered in Subjects With ALS
筋萎縮性側索硬化症(ALS)患者を対象とした経口エダラボンの多施設共同,非盲検,長期安全性試験(第III 相)
ALS
筋萎縮性側索硬化症
NCT04165824 (Update Oct 2020) JapicCTI-195070
(更新日 2020年10月)
Active, not recruiting
実施中(参加募集終了)
MT-1186
(Edaravone)
(エダラボン)
MT-1186-J04 Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis
筋萎縮性側索硬化症患者を対象としたエダラボンの臨床薬理試験
Japanese Patients With ALS
筋萎縮性側索硬化症
NCT04176224 (Registration Nov 2019) JapicCTI-195050
(登録日 2019年11月)
Completed
試験完了
MCI-196
(Colestimide/
Colestilan)
(コレスチミド/コレスチラン)
MCI196-19 Efficacy and Safety Study of MCI-196 in Patients With Type 2 Diabetes Type 2 Diabetes NCT00497198 (Update Jun 2012) - Completed
MCI-196
(Colestimide/
Colestilan)
(コレスチミド/コレスチラン)
MCI-196-A05 A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia Chronic Kidney Disease|Dialysis|Hyperphosphatemia NCT00506441 (Update Sep 2014) - Completed
MCI-196
(Colestimide/
Colestilan)
(コレスチミド/コレスチラン)
MCI-196-A06 Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia Chronic Kidney Disease|Dialysis|Hyperphosphatemia NCT00772382 (Update Sep 2014) - Completed
MCI-196
(Colestimide/
Colestilan)
(コレスチミド/コレスチラン)
MCI-196-E07 A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia Chronic Kidney Disease|Hyperphosphatemia NCT00416520 (Update Nov 2014) - Completed
MCI-196
(Colestimide/
Colestilan)
(コレスチミド/コレスチラン)
MCI-196-E08 A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia Chronic Kidney Disease|Dialysis|Hyperphosphatemia|Dyslipidemia NCT00542386 (Update Oct 2014) - Completed
MCI-196
(Colestimide/
Colestilan)
(コレスチミド/コレスチラン)
MCI-196-E09 A Phase III, Multi-Centre, Randomised, Placebo-Controlled Study in Combination With Ca-based P Binders in Patients With Hyperphosphatemia Chronic Kidney Disease|Dialysis|Hyperphosphatemia NCT00451295 (Update Nov 2011) - Terminated
MCI-196
(Colestimide/
Colestilan)
(コレスチミド/コレスチラン)
MCI-196-E10 A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia Chronic Kidney Disease|Dialysis|Hyperphosphatemia NCT00542815 (Update Oct 2014) - Completed
MCI-196
(Colestimide/
Colestilan)
(コレスチミド/コレスチラン)
MCI-196-E11 Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis Chronic Kidney Disease NCT00858637 (Update Dec 2014) - Completed
MCI-196
(Colestimide/
Colestilan)
(コレスチミド/コレスチラン)
MCI-196-E14 Dose-finding Study of MCI-196 Chronic Kidney Disease|Dialysis|Hyperphosphatemia|Paediatric NCT01814904 (Update May 2015) - Terminated
MCI-196
(Colestimide/
Colestilan)
(コレスチミド/コレスチラン)
MCI-196-E15 Long-term Extension Study of MCI-196 Chronic Kidney Disease|Dialysis|Hyperphosphatemia|Paediatric NCT01814917 (Update May 2015) - Terminated
MCI-196
(Colestimide/
Colestilan)
(コレスチミド/コレスチラン)
MCI-196-E16 Safety and Tolerability Study of MCI-196 Chronic Kidney Disease|Not on Dialysis|Hyperphosphatemia|Paediatric NCT01818687 (Update May 2015) - Terminated
MCI-9042
(Sarpogrelate)
(サルポグレラート)
MCI9042-15 Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS) Cerebral Infarction NCT00129805 (Update Aug 2008) - Completed
MCI-9042
(Sarpogrelate)
(サルポグレラート)
MCI9042-17 Effect of Sarpogrelate on Platelet Aggregation in Patients With Cerebral Infarction: Dose-responsive Clinical Pharmacology Study Cerebral Infarction NCT00147303 (Update Apr 2015) - Completed
MP-435 MP-435-J04 Efficacy and Safety Study of MP-435 in Combination With Methotrexate (MTX) in Patients With Rheumatoid Arthritis Rheumatoid Arthritis NCT01143337 (Update Oct 2014) - Completed
MT-1303
(Amiselimod)
MT-1303-E03 Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of MT-1303 in Subjects With Inflammatory Bowel Disease Inflammatory Bowel Disease NCT01666327 (Update Sep 2014) - Completed
MT-1303
(Amiselimod)
MT-1303-E04 Dose-finding Study of MT-1303 Relapsing-remitting Multiple Sclerosis NCT01742052 (Update Sep 2016) - Completed
MT-1303
(Amiselimod)
MT-1303-E05 Extension Study of MT-1303 Relapsing-remitting Multiple Sclerosis NCT01890655 (Update Apr 2016) - Completed
MT-1303
(Amiselimod)
MT-1303-E06 Dose-finding Study of MT-1303 in Subjects With Moderate to Severe Chronic Plaque Psoriasis Plaque Psoriasis NCT01987843 (Update Dec 2014) - Completed
MT-1303
(Amiselimod)
MT-1303-E13 Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease Crohn's Disease NCT02378688 (Update Oct 2016) - Completed
MT-1303
(Amiselimod)
MT-1303-E14 Extension Study of MT-1303 in Subjects With Crohn's Disease Crohn's Disease NCT02389790 (Update Sep 2017) - Completed
MT-1303
(Amiselimod)
MT-1303-J02 Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety Study of MT-1303 in Subjects With Crohn's Disease Crohn's Disease NCT02148185 (Update Sep 2014) - Completed
MT-1303
(Amiselimod)
MT-1303-J03 Exploratory Study of MT-1303 in Systemic Lupus Erythematosus Patients Systemic Lupus Erythematosus NCT02307643 (Update Jun 2017) - Completed
MT-2301 MT-2301-J01 Exploratory Clinical Study of MT-2301 Haemophilus Influenza Type b NCT02140047 (Update Oct 2015) - Completed
MT-2412
(Teneligliptin,Canagliflozin)
(テネリグリプチン、
カナグリフロジン)
MT-2412-J01 Long-Term Safety Study of MT-2412 in Japanese Patients With Type 2 Diabetes Type 2 Diabetes Mellitus NCT02220907 (Update Nov 2018) - Completed
MT-2412
(Teneligliptin,Canagliflozin)
(テネリグリプチン、
カナグリフロジン)
MT-2412-J02 Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Teneligliptin) Type 2 Diabetes Mellitus NCT02354222 (Update Nov 2018) - Completed
MT-2412
(Teneligliptin,Canagliflozin)
(テネリグリプチン、
カナグリフロジン)
MT-2412-J03 Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Canagliflozin) Type 2 Diabetes Mellitus NCT02354235 (Update Nov 2018) - Completed
MT-2990 MT-2990-A01 Safety and Efficacy Study of MT-2990 in Women With Endometriosis Endometrial Related Pain NCT03840993 (Update Sep 2020) - Recruiting
MT-2990 MT-2990-J01 A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients
MT-2990の季節性アレルギー性鼻炎患者を対象とした臨床薬理試験(単回投与試験)
Seasonal Allergic Rhinitis
季節性アレルギー性鼻炎
NCT03570957 (Update Jan 2019) JapicCTI-184025
(更新日 2019年1月)
Completed
試験完了 
MT-3921 MT-3921-G01 Safety and Pharmacokinetics Study of MT-3921 in Spinal Cord Injury Spinal Cord Injury NCT04096950 (Update Aug 2020) - Recruiting
MT-3995
(Apararenone)
MT-3995-E06 A Study to Evaluate Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects With Albuminuria Diabetic Nephropathy NCT01756703 (Update Feb 2015) - Completed
MT-3995
(Apararenone)
MT-3995-E07 A Study to Evaluate Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects With Albuminuria and Moderately Decreased GFR Diabetic Nephropathy NCT01756716 (Update Feb 2015) - Completed
MT-3995
(Apararenone)
MT-3995-J03 Safety, Tolerability and Pharmacokinetic Study of MT-3995 in Subjects With Diabetic Nephropathy Diabetic Nephropathy NCT01889277 (Update Jan 2015) - Completed
MT-3995
(Apararenone)
MT-3995-J04 Safety, Tolerability and Pharmacokinetic Study of MT-3995 at a Low Dose in Subjects With Diabetic Nephropathy Diabetic Nephropathy NCT02205372 (Update Sep 2015) - Completed
MT-3995
(Apararenone)
MT-3995-J05 Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy Diabetic Nephropathy NCT02517320 (Update Mar 2017) - Completed
MT-3995
(Apararenone)
MT-3995-J06 An Extended Treatment Study of MT-3995 in Patients With Diabetic Nephropathy Diabetic Nephropathy NCT02676401 (Update Sep 2017) - Completed
MT-3995
(Apararenone)
MT-3995-J07 Efficacy and Safety of MT-3995 in Patients With Non-Alcoholic Steatohepatitis(NASH) NASH NCT02923154 (Update Sep 2019) - Completed
MT-5199
(Valbenazine)
MT-5199-J02 Efficacy and Safety of MT-5199 in Subjects With Tardive Dyskinesia
MT-5199の遅発性ジスキネジア患者を対象とした検証的試験及び継続長期投与試験
Tardive Dyskinesia
遅発性ジスキネジア
NCT03176771 (Update Oct 2020) JapicCTI-184016
(更新日 2020年10月)
Completed
試験完了
MT-5547
(Fasinumab)
(ファシヌマブ)
MT-5547-J01 Efficacy and Safety of MT-5547 in Patients With Osteoarthritis Accompanied by Moderate to Severe Pain Osteoarthritis, Knee / Osteoarthritis, Hip NCT03245008 (Update Oct 2019) - Active, not recruiting
MT-5625 MT-5625-01 Safety and Immunogenicity of MT-5625 in Healthy Adults, Toddlers and Infants Healthy NCT03507738 (Update Aug 2019) - Completed
MT-6548
(Vadadustat)
(バダデュスタット)
MT-6548-J01 Efficacy and Safety Study to Evaluate MT-6548 in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan Anemia; Non-dialysis Dependent Chronic Kidney Disease NCT03329196 (Update Oct 2019) - Completed
MT-6548
(Vadadustat)
(バダデュスタット)
MT-6548-J02 Efficacy and Safety Study to Evaluate MT-6548 in Peritoneal Dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan Anemia; Peritoneal Dialysis Dependent Chronic Kidney Disease NCT03402386 (Update Mar 2019) - Completed
MT-6548
(Vadadustat)
(バダデュスタット)
MT-6548-J03 Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Currently Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan Anemia; Hemodialysis Dependent Chronic Kidney Disease NCT03439137 (Update Oct 2019) - Completed
MT-6548
(Vadadustat)
(バダデュスタット)
MT-6548-J04 Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Not Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan Anemia; Hemodialysis Dependent Chronic Kidney Disease NCT03461146 (Update Mar 2019) - Completed
MT-7117
(Dersimelagon)
MT-7117-A01 Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Erythropoietic Protoporphyria Erythropoietic Protoporphyria (EPP) NCT03520036 (Update Sep 2020) - Completed
MT-8554
(Elismetrep)
MT-8554-A01 MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women Menopause Hot Flashes NCT03291067 (Update Oct 2019) - Completed
MT-8554
(Elismetrep)
MT-8554-A02 Long-term Safety and Efficacy Study of MT-8554 in Postmenopausal Women With Vasomotor Symptoms Vasomotor Symptoms (VMS) NCT03541200 (Update Jan 2020) - Completed
MT-8554
(Elismetrep)
MT-8554-E04 A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of MT-8554 in Female Subjects Experiencing Vasomotor Symptoms Vasomotor Symptoms NCT02803268 (Update Feb 2017) - Completed
MT-8554
(Elismetrep)
MT-8554-E06 Study to Assess the Efficacy, Safety and Tolerability of MT- 8554 in Subjects With Painful Diabetic Peripheral Neuropathy Painful Diabetic Peripheral Neuropathy NCT03172598 (Update Aug 2018) - Completed
TA-650
(Infliximab
[recombinant])
(インフリキシマブ
〔遺伝子組換え〕)
TA-650-13 Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis
TA-650の関節リウマチを対象とした増量試験
Rheumatoid Arthritis
関節リウマチ
NCT00691028 (Update Mar 2014) JapicCTI-050146
(更新日 2016年1月)
Completed
試験完了
TA-650
(Infliximab
[recombinant])
(インフリキシマブ
〔遺伝子組換え〕)
TA-650-14 Clinical study to assess the efficacy and safety of TA-650 in patients with active ulcerative colitis
TA-650の潰瘍性大腸炎患者を対象とした検証的試験(プラセボを対照薬とした二重盲検比較試験) 
Ulcerative colitis
潰瘍性大腸炎
- JapicCTI-060298
(更新日 2016年1月)
Completed
試験完了
TA-650
(Infliximab
[recombinant])
(インフリキシマブ
〔遺伝子組換え〕)
TA-650-15 Clinical study to evaluate the efficacy and safety of TA-650 in patients with psoriasis
TA-650の乾癬患者を対象とした検証的試験(プラセボを対照薬とした二重盲検比較試験)
Psoriasis
乾癬
- JapicCTI-060318
(更新日 2016年1月)
Completed
試験完了
TA-650
(Infliximab
[recombinant])
(インフリキシマブ
〔遺伝子組換え〕)
TA-650-17 Long-term study of TA-650 in patients with psoriasis
TA-650の乾癬患者を対象とした長期投与試験
Psoriasis
乾癬
- JapicCTI-060319
(更新日 2016年1月)
Completed
試験完了
TA-650
(Infliximab
[recombinant])
(インフリキシマブ
〔遺伝子組換え〕)
TA-650-18 Clinical study of TA-650 in patients with ankylosing spondylitis
TA-650の強直性脊椎炎患者を対象とした臨床試験
Ankylosing spondylitis
強直性脊椎炎
- JapicCTI-070346
(更新日 2016年1月)
Completed
試験完了
TA-650
(Infliximab
[recombinant])
(インフリキシマブ
〔遺伝子組換え〕)
TA-650-19 Efficacy and Safety of Increased Dose of TA-650 (Infliximab) in Patients With Crohn's Disease (CD)
TA-650のクローン病を対象とした増量試験
Crohn's Disease
市販薬レミケードの投与を受けているクローン病患者
NCT00805766 (Update Feb 2018) JapicCTI-080663
(更新日 2016年1月)
Completed
試験完了
TA-650
(Infliximab
[recombinant])
(インフリキシマブ
〔遺伝子組換え〕)
TA-650-20 Clinical Study of TA-650 in Pediatric Patients With Crohn's Disease Pediatric Crohn's Disease NCT01580670 (Update Jul 2019) - Completed
TA-650
(Infliximab
[recombinant])
(インフリキシマブ
〔遺伝子組換え〕)
TA-650-21 Clinical Study of TA-650 in Pediatric Patients With Ulcerative Colitis Pediatric Ulcerative Colitis NCT01585155 (Update Nov 2019) - Completed
TA-650
(Infliximab
[recombinant])
(インフリキシマブ
〔遺伝子組換え〕)
TA-650-22 Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin NCT01596335 (Update Oct 2018) - Completed
TA-650
(Infliximab
[recombinant])
(インフリキシマブ
〔遺伝子組換え〕)
TA-650-23 Clinical Study of TA-650 in Patients With Behcet's Disease (BD) With Special Lesions Behcet's Disease|Behcet Syndrome|Neuro-Behcet's Disease NCT01532570 (Update Dec 2016) - Completed
TA-650
(Infliximab
[recombinant])
(インフリキシマブ
〔遺伝子組換え〕)
TA-650-24 A Clinical Study of Increased Dose of TA-650 in Patients With Psoriasis Plaque Psoriasis|Psoriatic Arthritis|Pustular Psoriasis (Excluding a Localized)|Psoriatic Erythroderma NCT01680159 (Update Mar 2017) - Completed
TA-7284
(Canagliflozin)
(カナグリフロジン水和物)
TA-7284-02 Safety, Pharmacokinetics and Pharmacodynamics of TA-7284 in Type 2 Diabetic Patients Type 2 Diabetes Mellitus NCT00707954 (Update Apr 2014) - Completed
TA-7284
(Canagliflozin)
(カナグリフロジン水和物)
TA-7284-04 An Efficacy, Safety, and Tolerability Study for TA-7284 in Patients With Type 2 Diabetes Type 2 Diabetes Mellitus NCT01022112 (Update Jun 2014) - Completed
TA-7284
(Canagliflozin)
(カナグリフロジン水和物)
TA-7284-05 Efficacy and Safety Study of TA-7284 in Patients With Type 2 Diabetes Type 2 Diabetes Mellitus NCT01413204 (Update Jun 2014) - Completed
TA-7284
(Canagliflozin)
(カナグリフロジン水和物)
TA-7284-06 Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus Type 2 Diabetes Mellitus NCT01387737 (Update Jun 2014) - Completed
TA-7284
(Canagliflozin)
(カナグリフロジン水和物)
TA-7284-07 A Study to Evaluate the PK/PD and Safety of TA-7284 in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment Type 2 Diabetes Mellitus NCT01512849 (Update Jun 2014) - Completed
TA-7284
(Canagliflozin)
(カナグリフロジン水和物)
TA-7284-11 Efficacy and Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus Type 2 Diabetes Mellitus NCT02220920 (Update Dec 2016) - Completed
TA-7284
(Canagliflozin)
(カナグリフロジン水和物)
TA-7284-12 Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus Type 2 Diabetes Mellitus NCT02227849 (Update Apr 2019) - Completed
TA-7284
(Canagliflozin)
(カナグリフロジン水和物)
TA-7284-13 Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus Type 2 Diabetes Mellitus NCT02622113 (Update Apr 2019) - Completed
TA-7284
(Canagliflozin)
(カナグリフロジン水和物)
TA-7284-14 Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy Diabetic Nephropathy NCT03436693 (Update Apr 2020) - Active, not recruiting
TAU-284
(Bepotastine)
(ベポタスチンベシル酸塩)
TAU-284-17 A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis Perennial Allergic Rhinitis NCT01425632 (Update Dec 2015) - Completed
TAU-284
(Bepotastine)
(ベポタスチンベシル酸塩)
TAU-284-18 A Long-Term Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis Perennial Allergic Rhinitis NCT01900054 (Update Apr 2016) - Completed
TAU-284
(Bepotastine)
(ベポタスチンベシル酸塩)
TAU-284-19 A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis Dermatitis|Atopic NCT01840605 (Update May 2018) - Completed
TAU-284
(Bepotastine)
(ベポタスチンベシル酸塩)
TAU-284-20 The Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis Perennial Allergic Rhinitis NCT01861522 (Update Dec 2015) - Completed
AFT-801 Phase 3 clinical study of AFT-801(confirmatory study 0305) Double-blind, placebo-controlled study for excessive daytime sleepiness accompanying obstructive sleep apnea syndrome in CPAP-treated patients
AFT-801の第3相臨床試験(検証的試験0305) CPAP治療中の閉塞性睡眠時無呼吸症候群に伴う日中の過度の眠気に対するプラセボを対照とした二重盲検比較試験
Excessive daytime sleepiness accompanying obstructive sleep apnea syndrome in CPAP-treated patients
CPAP治療中の閉塞性睡眠時無呼吸症候群に伴う日中の過度の眠気
- JapicCTI-090777
(更新日 2015年10月)
Completed
試験完了
AFT-801 Phase III clinical study of AFT-801 (long-term administration study) Open-label study for excessive daytime sleepiness accompanying obstructive sleep apnea syndrome in CPAP-treated patients
AFT-801の第3相臨床試験(長期投与試験)CPAP治療中の閉塞性睡眠時無呼吸症候群に伴う日中の過度の眠気に対するオープンラベル試験
Excessive daytime sleepiness accompanying obstructive sleep apnea syndrome in CPAP-treated patients
CPAP治療中の閉塞性睡眠時無呼吸症候群に伴う日中の過度の眠気
- JapicCTI-070362
(更新日 2015年10月)
Completed
試験完了
AFT-801 Phase III clinical study of AFT-801 (confirmatory study) Double-blind, placebo-controlled study for excessive daytime sleepiness accompanying obstructive sleep apnea syndrome in CPAP-treated patients
AFT-801の第3相臨床試験(検証的試験)CPAP治療中の閉塞性睡眠時無呼吸症候群に伴う日中の過度の眠気に対するプラセボを対照とした二重盲検比較試験
Excessive daytime sleepiness accompanying obstructive sleep apnea syndrome in CPAP-treated patients
CPAP治療中の閉塞性睡眠時無呼吸症候群に伴う日中の過度の眠気
- JapicCTI-070361
(更新日 2015年10月)
Completed
試験完了
CNTO148
(Golimumab)
(ゴリムマブ)
CNTO148(Golimumab)の関節リウマチ患者を対象とした単剤投与試験 関節リウマチ(DMARD治療にも関わらず活動性を有する患者) - JapicCTI-080595
(更新日 2015年6月)
Completed
試験完了
CNTO148
(Golimumab)
(ゴリムマブ)
CNTO148(Golimumab)の関節リウマチ患者を対象としたMTX併用投与試験 関節リウマチ(MTX治療にも関わらず活動性を有する患者) - JapicCTI-080594
(更新日 2015年6月)
Completed
試験完了
MCC-847
(Masilukast)
(マシルカスト)
Confirmatory Study of MCC-847 for the treatment of adult asthma
成人気管支喘息を対象としたMCC-847の二重盲検群間比較による検証的試験
Adult asthma
成人気管支喘息
- JapicCTI-050054
(更新日 2015年10月)
Completed
試験完了
TA-4708
(Bisoprolol Fumarate)
(ビソプロロールフマル酸塩)
A Clinical Study of TA-4708 in Patients with Chronic Atrial Fibrillation
慢性心房細動患者を対象としたTA-4708(ビソプロロールフマル酸塩)の臨床試験
chronic atrial fibrillation
慢性心房細動
- JapicCTI-111562
(更新日 2015年10月)
Completed
試験完了
TA-4708
(Bisoprolol Fumarate)
(ビソプロロールフマル酸塩)
Phase 3 Clinical Study of TA-4708 (Bisoprolol Fumarate) in Patients with Chronic Heart Failure
TA-4708(ビソプロロールフマル酸塩)の慢性心不全患者を対象とした第III相検証的試験
chronic heart failure
慢性心不全
- JapicCTI-101045
(更新日 2015年10月)
Terminated
試験中止(恒久的)
TA-8317 Long-term study of TA-8317 in patients with cancer breakthrough pain
 TA-8317のがん疼痛を有する患者を対象とした長期投与試験 
Cancer breakthrough pain
がん性突出痛
- JapicCTI-060307
(更新日 2015年10月)
Completed
試験完了
TA-8317 Confirmatory study of TA-8317 in patients with cancer breakthrough pain Open-label, crossover, comparative study using a comparator, morphine used as rescue medication
TA-8317のがん疼痛を有する患者を対象とした検証的試験(モルヒネレスキューを対照薬とした非盲検クロスオーバー比較試験)
Cancer breakthrough pain
がん性突出痛
- JapicCTI-060306
(更新日 2015年10月)
Completed
試験完了

2. 研究者との臨床試験データの共有

当社は、資格要件を満たす科学・医学分野の研究者の方から要請があり、専門家を含む審査委員会が妥当であると判断した場合は、患者さんごとに得られた個別の臨床試験データを研究者と共有します。共有する臨床試験データは、すべて匿名化した上で提供します。なお患者さんを特定するリスクがあると判断された場合には提供を差し控えます。

共有対象は、2018年1月以降に初めて、米国、欧州及び日本のうち承認を目指す全ての地域で承認を取得した製品の承認申請に用いた患者さんを対象とした臨床試験です。その他の条件は、下記のリンクからご確認いただけます。

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

データの共有を希望される研究者の方は、下記のリンクを通じて、ご依頼ください。

https://vivli.org/

3. 臨床試験結果のパブリケーション

当社は、医学的に重要と考えられる臨床試験の結果について、適切な時期に学会での発表、学術誌への論文投稿を行うよう努めます。論文が公表された場合は、一般に公開されている臨床試験情報登録サイトに、公表先を登録いたします。

4. 臨床試験に参加された患者さんへの臨床試験結果の共有

当社は、当社の臨床試験に参加いただいた患者さんと、患者さんごとの個別の臨床試験結果の共有を予定しており、現在準備中です。

お問い合わせ

臨床試験情報の開示に関するご質問は、以下のメールアドレスからお問い合わせください。

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