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Last Updated: November 18, 2019

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CLINICAL TRIALS PROFILE FOR APREPITANT

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505(b)(2) Clinical Trials for Aprepitant

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Indication NCT00090155 2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-090)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 3 2003-09-01 The purpose of this study is to assess the safety and efficacy of 2 doses of an approved drug for a new indication in the prevention of postoperative nausea and vomiting in patients receiving general anesthesia for open abdominal surgery requiring overnight hospital stay.
New Indication NCT00090246 2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-091) Completed Merck Sharp & Dohme Corp. Phase 3 2004-05-01 The purpose of this study is to assess the safety and efficacy of 2 doses of an approved drug for a new indication in the prevention of postoperative nausea and vomiting in patients receiving general anesthesia for open abdominal surgery requiring overnight hospital stay.
New Combination NCT01012336 Safety and Efficacy of Aprepitant, Ramosetron, and Dexamethasone for Chemotherapy-Induced Nausea and Vomiting in Patients With Ovarian Cancer Treated With Taxane/Carboplatin Completed Merck Sharp & Dohme Corp. Phase 2 2010-05-01 The current recommended guideline for patients receiving moderately emetogenic chemotherapy (MEC) is the combination of a 5-HT3 receptor antagonist and corticosteroid. Incidence of chemotherapy induced nausea and vomiting (CINV) is approximately 50% in patients receiving MEC. An incidence rate of 25-38% for delayed emesis and 55-60% for delayed nausea has been observed. Hence, there is clearly a need for more effective prevention of CINV in patients receiving MEC, especially in women with ovarian carcinoma who are particularly susceptible to these symptoms. Therefore the investigators designed a study with the objective to evaluate if new combination (Aprepitant/Ramosetron/Dexamethasone) may improve actual CINV control in ovarian carcinoma patients treated with taxane/carboplatin.
New Combination NCT01012336 Safety and Efficacy of Aprepitant, Ramosetron, and Dexamethasone for Chemotherapy-Induced Nausea and Vomiting in Patients With Ovarian Cancer Treated With Taxane/Carboplatin Completed Samsung Medical Center Phase 2 2010-05-01 The current recommended guideline for patients receiving moderately emetogenic chemotherapy (MEC) is the combination of a 5-HT3 receptor antagonist and corticosteroid. Incidence of chemotherapy induced nausea and vomiting (CINV) is approximately 50% in patients receiving MEC. An incidence rate of 25-38% for delayed emesis and 55-60% for delayed nausea has been observed. Hence, there is clearly a need for more effective prevention of CINV in patients receiving MEC, especially in women with ovarian carcinoma who are particularly susceptible to these symptoms. Therefore the investigators designed a study with the objective to evaluate if new combination (Aprepitant/Ramosetron/Dexamethasone) may improve actual CINV control in ovarian carcinoma patients treated with taxane/carboplatin.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Aprepitant

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00080444 Study of Aprepitant (MK-0869) for Chemotherapy-Induced Nausea and Vomiting (CINV) in Adolescent Participants (MK-0869-097) Completed Merck Sharp & Dohme Corp. Phase 3 2004-04-01 This study is being conducted to demonstrate that aprepitant (MK-0869) prevents nausea and vomiting caused by emetogenic cancer chemotherapy in adolescent participants. Participants treated with emetogenic cancer chemotherapies that include either cisplatin, cyclophosphamide, or carboplatin, or participants who experienced nausea and/or vomiting when treated with a previously administered chemotherapy regimen that is planned to be repeated will be enrolled in this study. In the double-blind Part 1 of this study, enrolled participants will be randomized to receive either aprepitant or standard therapy. In Part 2 of this study, enrolled participants will receive open-label aprepitant.
NCT00090155 2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-090)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 3 2003-09-01 The purpose of this study is to assess the safety and efficacy of 2 doses of an approved drug for a new indication in the prevention of postoperative nausea and vomiting in patients receiving general anesthesia for open abdominal surgery requiring overnight hospital stay.
NCT00090207 Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Highly Emetogenic Chemotherapy (0869-801)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 4 2004-01-01 A multicenter trial to assess the safety and efficacy of an investigational drug in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with confirmed solid tumors who will be treated with a chemotherapy regimen that includes cisplatin. The study will evaluate the investigational drug for the treatment of CINV during the first cycle of treatment with cisplatin.
NCT00090246 2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-091) Completed Merck Sharp & Dohme Corp. Phase 3 2004-05-01 The purpose of this study is to assess the safety and efficacy of 2 doses of an approved drug for a new indication in the prevention of postoperative nausea and vomiting in patients receiving general anesthesia for open abdominal surgery requiring overnight hospital stay.
NCT00092183 An Investigational Drug for the Prevention of Chemotherapy-Induced Nausea and Vomiting (MK-0869-071) Completed Merck Sharp & Dohme Corp. Phase 4 2002-10-01 This protocol will study an investigational drug treatment plan against standard therapy in the prevention of chemotherapy-induced nausea and vomiting in patients diagnosed with breast cancer who are to be treated with up to 4 cycles of non-cisplatin moderately emetogenic chemotherapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Aprepitant

Condition Name

Condition Name for Aprepitant
Intervention Trials
Vomiting 26
Nausea 25
Chemotherapy-induced Nausea and Vomiting 18
Postoperative Nausea and Vomiting 18
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Condition MeSH

Condition MeSH for Aprepitant
Intervention Trials
Vomiting 87
Nausea 71
Postoperative Nausea and Vomiting 27
Breast Neoplasms 7
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Clinical Trial Locations for Aprepitant

Trials by Country

Trials by Country for Aprepitant
Location Trials
United States 96
Italy 13
Korea, Republic of 7
China 7
Brazil 6
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Trials by US State

Trials by US State for Aprepitant
Location Trials
Pennsylvania 11
North Carolina 8
New York 7
Missouri 6
California 6
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Clinical Trial Progress for Aprepitant

Clinical Trial Phase

Clinical Trial Phase for Aprepitant
Clinical Trial Phase Trials
Phase 4 29
Phase 3 31
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Aprepitant
Clinical Trial Phase Trials
Completed 74
Not yet recruiting 17
Recruiting 15
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Clinical Trial Sponsors for Aprepitant

Sponsor Name

Sponsor Name for Aprepitant
Sponsor Trials
Merck Sharp & Dohme Corp. 46
National Cancer Institute (NCI) 10
National Institute on Drug Abuse (NIDA) 6
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Sponsor Type

Sponsor Type for Aprepitant
Sponsor Trials
Other 147
Industry 56
NIH 20
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