A Study to Test the Safety and Efficacy of MK0249 in Patients With ADHD (0249-018)(COMPLETED)

PHASE2CompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

April 30, 2008

Study Completion Date

April 30, 2008

Conditions
Attention-Deficit/Hyperactivity Disorder (ADHD)
Interventions
DRUG

MK0249

MK-0249, 10 mg per day was taken orally daily. If patients were unable to tolerate 10 mg per day, they were allowed to titrate down to 5 mg per day.

DRUG

Concerta (methylphenidate)

Titration of Concerta began with two 18-mg capsules (36 mg) for 3 consecutive days, followed by three 18-mg capsules (54 mg) for another 3 consecutive days, ending with four 18-mg capsules (72 mg) for the remainder of the treatment period. If patients were unable to tolerate 72 mg per day, they were allowed to titrate down to 54 mg per day. Concerta was taken orally once daily.

DRUG

Placebo

For 4 of the 6 treatment sequences, patients had one 4-week treatment period with placebo of MK-0249 (tablets) and placebo of Concerta (capsules). For patients assigned to active treatments of MK-0249 or Concerta, in order to preserve the blind, placebo of the non-active component was provided, ie, if MK was assigned (tablets), then placebo of Concerta (capsules) was also provided. Each patient was to dose with tablets and capsules, either active or placebo. Placebo was taken orally once daily.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT00475735 - A Study to Test the Safety and Efficacy of MK0249 in Patients With ADHD (0249-018)(COMPLETED) | Biotech Hunter | Biotech Hunter