Trials / Completed
CompletedNCT03605680
A Trial Evaluating the Efficacy, Safety, & Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder
A Phase 3, Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group Trial Evaluating the Efficacy, Safety, and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 604 (actual)
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluates the efficacy, safety, and tolerability of centanafadine sustained-release tablets in adults with attention-deficit/hyperactivity disorder (ADHD). Participants will either receive a twice-daily dose of centanafadine sustained-release tablets, or twice-daily placebo.
Detailed description
Screening \& Washout Period: up to 28 days Investigational Treatment Period: 49 days Follow-up Period : 7 days or 10 days
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Centanafadine SR | 100 mg, BID, oral tablets |
| OTHER | Placebo | BID, oral tablet. |
| DRUG | Centanafadine SR | 200 mg, BID, oral tablets |
Timeline
- Start date
- 2019-01-16
- Primary completion
- 2020-04-11
- Completion
- 2020-04-11
- First posted
- 2018-07-30
- Last updated
- 2022-03-15
- Results posted
- 2021-05-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03605680. Inclusion in this directory is not an endorsement.