Official title: A Phase II Tolerability and Efficacy Study of PDC-1421 Treatment in Adult Patients With Attention-Deficit Hyperactivity Disorder (ADHD), Part II
Clinical Trial Summary
Part II is a double-blind, randomized, parallel-group, placebo-controlled study. The primary
objective of this trial is to determine the effective doses and treatment period of PDC-1421
Capsule in subjects with ADHD. The secondary objective is to evaluate the safety of PDC-1421
Capsule in subjects receiving PDC-1421 at various dose levels.
Clinical Trial Description
The screening phase is intended for diagnosing and assessing the patient for possible
inclusion in the study and for providing an adequate washout period.
At the first stage, a number of 69 subjects will be randomly assigned on a 1:1:1 basis to one
of the three arms (1 PDC-1421 Capsule plus 1 placebo TID, 2 PDC-1421 Capsules TID, 2 placebo
TID) for 8 weeks and evaluated the safety and efficacy every two weeks during the treatment
period. An interim analysis will be conducted to evaluate the efficacy of PDC-1421 and to
decide whether it is necessary to enter the second stage of the Part II study in which 30
subjects will be randomly assigned on a 1:1:1 basis to one of the three treatment arms and
receive the same treatment.
Simple descriptive statistics with a 95% confidence interval will be performed with data
collected in this study wherever applicable. The safety and efficacy data will be analyzed
using the non-parametric method wherever appropriate.
The primary endpoint will be analyzed by chi-square test, while the secondary endpoints will
be analyzed using the ANOVA or Kruskal-Wallis non-parametric ANOVA test for continuous
endpoints and chi-square test for binary endpoints.
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Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.