Trials / Completed
CompletedNCT01074255
Re-examination Study of EMEND (Aprepitant) (MK-0869-184)
Re-examination Study For General Drug Use to Assess the Safety and Efficacy Profile of EMEND in Usual Practice
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 3,546 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation. Its aim is to reconfirm the clinical usefulness of EMEMD (aprepitant) through collecting the safety information according to the Re-examination Regulation for New Drugs.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | EMEND | EMEND (Aprepitant,125 mg oral capsules) is administered 1 hour prior to chemotherapy on treatment Day 1. EMEND (80 mg) is administered on the morning of Days 2 and 3. EMEND is concomitantly administered with a regimen of a corticosteroid and a 5-HT3 antagonist. |
Timeline
- Start date
- 2007-04-01
- Primary completion
- 2011-10-01
- Completion
- 2011-10-01
- First posted
- 2010-02-24
- Last updated
- 2015-04-21
- Results posted
- 2012-10-05
Source: ClinicalTrials.gov record NCT01074255. Inclusion in this directory is not an endorsement.