A Study to Evaluate the Safety, Tolerability and Plasma Concentration Profiles of MK0633 in Asthmatic Children Aged 12 to Less Than 16 Years
This study has been completed.
Information provided by:
First received: March 26, 2008
Last updated: May 6, 2009
Last verified: May 2009
To evaluate the safety, tolerability and pharmacokinetics (PK) of MK0633 in adolescent mild-to-moderate asthma patients to permit further clinical investigation.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter, Open-Label, Single Dose Study to Evaluate the Safety, Tolerability and Plasma Concentration Profiles of MK0633 in Asthmatic Children Aged 12 to Less Than 16 Years|
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- To evaluate the safety and tolerability of MK0633 in adolescent asthma patients. [ Time Frame: Blood and urine samples will be collected at specified intervals for 72 hours after study drug administration. ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2008|
|Estimated Study Completion Date:||June 2009|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Drug: Comparator: MK0633
patients will receive single 50mg oral dose with follow-up observation for 5 weeks.
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