Home
Search
Study Topics
Glossary
|
|
|
|
|
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date † | February 23, 2009 | ||||
Last Updated Date | April 14, 2009 | ||||
Start Date † | February 2009 | ||||
Current Primary Outcome Measures † |
Mean change in the QTcF (Fridericia's correction) between each active treatment and placebo [ Time Frame: Following four days of dosing ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00850746 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
|
||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | A Study to Evaluate the Effect of Repeat Oral Doses of YM443 on Cardiac Repolarization in Healthy Adults | ||||
Official Title † | A Phase 1, Randomized, Double-Blind, Placebo- and Active- Controlled, Crossover Study to Evaluate the Effect of Repeat Oral Doses of YM443 on Cardiac Repolarization in Healthy Male and Female Adult Subjects | ||||
Brief Summary | This study evaluates whether YM443 causes any changes in the electrocardiogram of healthy adults. |
||||
Detailed Description | Each subject participates in all four treatment periods separated by washout periods. In order to maintain the blind between arms, all subjects will receive the same number of tablets per day in each period of either active drug or placebo. |
||||
Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Other, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Safety Study | ||||
Condition † | Cardiac Repolarization | ||||
Intervention † |
|
||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 80 | ||||
Completion Date | April 2009 | ||||
Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||
Gender | Both | ||||
Ages | 18 Years to 50 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00850746 | ||||
Responsible Party | Sr Manager Clincal Trials Registry, Astellas Pharma Global Development | ||||
Secondary IDs †† | |||||
Study Sponsor † | Astellas Pharma Inc | ||||
Collaborators †† | |||||
Investigators † |
|
||||
Information Provided By | Astellas Pharma Inc | ||||
Verification Date | April 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |