Trials / Completed
CompletedNCT01376141
Drug Use Investigation for IMIGRAN Tablet
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 3,571 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- —
Summary
The study is designed to detect adverse drug reactions (particularly clinically significant adverse drug reactions) occurring in clinical settings, to examine factors likely to affect the safety and efficacy of sumatriptan tablet, and to discuss the need of special investigation and postmarketing clinical study. A special focus was placed on the investigation of occurrence of "ischaemic heart disease-like events including arrhythmia, angina pectoris, and myocardial infarction" in the present study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sumatriptan |
Timeline
- Start date
- 2001-09-01
- Primary completion
- 2005-02-01
- Completion
- 2005-11-01
- First posted
- 2011-06-20
- Last updated
- 2017-05-22
Source: ClinicalTrials.gov record NCT01376141. Inclusion in this directory is not an endorsement.