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NCT04308434 · ClinicalTrials.gov registry record · NA
CSD190601: A Study to Determine Subject Puffing Patterns of Electronic Nicotine Delivery Systems in an Ambulatory Setting
A NA study, sponsored by RAI Services Company.
- Completed
- Registry status
- NA
- Development phase
- 107
- Enrollment target
NCT04308434: Completed NA study, sponsored by RAI Services Company.
NCT04308434 is a NA study that has completed, run by RAI Services Company. The registered enrollment target is 107 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04308434, a NA study, has completed, sponsored by RAI Services Company.
- COMPLETED
- Registry status
- NA
- Development phase
- 107 participants
- Enrollment target
Study Summary
This study will be a single-center, controlled, open-label, parallel two-study-group investigation to evaluate the puffing patterns of healthy adult consumers of tobacco products switching from a usual brand (UB) Electronic Nicotine Delivery Systems (ENDS) product to one of two different ENDS, Product A with 1.5% nicotine, and Product B with 3.0% nicotine, over a three-week ambulatory period. This study will be conducted in support of a Premarket Tobacco Product Application (PMTA) ENDS submission to the US Food and Drug Administration (FDA) Center for Tobacco Products (CTP).
Primary Outcome
Arithmetic Mean puff duration
Interventions
- OTHER CSD190601-11
- OTHER CSD190601-12
- OTHER CSD190601-13
- OTHER CSD190601-14
- OTHER CSD190601-15
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2020-05-26 |
| Est. Completion | 2020-10-22 |
| Phase | NA |
What the finished NCT04308434 record still lists
NCT04308434 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 5 interventions - of which CSD190601-11 is the first listed.
NCT04308434 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04308434 about?
NCT04308434 is a clinical study titled "CSD190601: A Study to Determine Subject Puffing Patterns of Electronic Nicotine Delivery Systems in an Ambulatory Setting". This study will be a single-center, controlled, open-label, parallel two-study-group investigation to evaluate the puffing patterns of healthy adult consumers of tobacco products switching from a usual brand (UB) Electronic Nicotine Delivery Systems (ENDS) product to one of two different ENDS, Produ...
What is the current status of trial NCT04308434?
This trial is currently completed. It is a NA study. The enrollment target is 107 participants. The study started on 2020-05-26. Estimated completion is 2020-10-22.
What interventions are being tested in trial NCT04308434?
The interventions under investigation include: CSD190601-11 (OTHER), CSD190601-12 (OTHER), CSD190601-13 (OTHER), CSD190601-14 (OTHER), CSD190601-15 (OTHER).
Who is sponsoring clinical trial NCT04308434?
This trial is sponsored by RAI Services Company, which has 42 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04308434's enrollment target sits among peer trials
107 830th of 2000 higher than 1,171 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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