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Trial · NCT00697515

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPermanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase2, 4, 8, 10, 12 and 14 hours post-dose on Day 7Intent to Treat (ITT) population defined as all subjects who are randomized and have at least one post-dose primary efficacy assessment.Units on a scaleLEAST_SQUARES_MEAN
SECONDARYPERMP Total Score by Timepoint in the Crossover Phase2, 4, 8, 10, 12 and 14 hours post-dose on Day 7ITTUnits on a scaleLEAST_SQUARES_MEAN
SECONDARYPERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase2, 4, 8, 10, 12 and 14 hours post-dose on Day 7ITTUnits on a scaleLEAST_SQUARES_MEAN
SECONDARYPERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase2, 4, 8, 10, 12 and 14 hours post-dose on Day 7ITTUnits on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale With Prompts (ADHD-RS) Total Score at up to 28 Days in the Dose Optimization PhaseBaseline and 7, 14, 21 and 28 daysEnrolled Efficacy Population (EEP) defined as all subjects who have taken one dose of study medication in the Dose Optimization Phase and had one post-Baseline efficacy assessment.Units on a scaleMEAN
SECONDARYADHD-RS With Prompts Total Score in the Crossover Phase7 daysITTUnits on a scaleLEAST_SQUARES_MEAN
SECONDARYAssessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization PhaseBaselineEEPParticipantsNUMBER
SECONDARYNumber of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Dose Optimization Phase7, 14, 21 and 28 daysEEPParticipantsNUMBER
SECONDARYNumber of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Crossover Phase7 daysITTParticipantsNUMBER
SECONDARYChange From Baseline in the Brown Attention Deficit Disorder Scale (BADDS) Total Scores at 26 Days in the Dose Optimization PhaseBaseline and 26 daysEEPUnits on a scaleMEAN
SECONDARYLevel of Satisfaction With Study Treatment on Medication Satisfaction Questionnaire (MSQ) in the Dose Optimization Phase26 daysEEPParticipantsNUMBER
SECONDARYChange From Baseline in Adult ADHD Impact Module (AIM-A) Question 1 Score at 26 Days in the Dose Optimization PhaseBaseline and 26 daysEEPUnits on a scaleMEAN
SECONDARYChange From Baseline in AIM-A Question 4 Score at 26 Days in the Dose Optimization PhaseBaseline and 26 daysUnits on a scaleMEAN
SECONDARYChange From Baseline in Systolic Blood Pressure at Up to 28 Days in the Dose Optimization PhaseBaseline and 7, 14, 21 and 28 daysSafety Population (SP) defined as all subjects who received at least one dose of study medication.mmHgMEAN
SECONDARYChange From Baseline in Diastolic Blood Pressure at Up to 28 Days in the Dose Optimization PhaseBaseline and 7, 14, 21 and 28 daysSPmmHgMEAN
SECONDARYChange From Baseline in Pulse Rate at Up to 28 Days in the Dose Optimization PhaseBaseline and 7, 14, 21 and 28 daysSPbpmMEAN
SECONDARYChange From Baseline in Electrocardiogram Results (QTcF Interval) at 7 Days in the Crossover PhaseBaseline and 7 daysSPmsecMEAN

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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