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NCT04800211 · ClinicalTrials.gov registry record · NA
Biomarkers of Exposure and Biomarkers of Potential Harm in Adult Smokers Who Completely Switch to E-vapor Products
A NA study, sponsored by Altria Client Services.
- Completed
- Registry status
- NA
- Development phase
- 450
- Enrollment target
NCT04800211: Completed NA study, sponsored by Altria Client Services.
NCT04800211 is a NA study that has completed, run by Altria Client Services. The registered enrollment target is 450 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04800211, a NA study, has completed, sponsored by Altria Client Services.
- COMPLETED
- Registry status
- NA
- Development phase
- 450 participants
- Enrollment target
Study Summary
The purpose of this study was to estimate changes in biomarkers of exposure (BoE) and biomarkers of potential harm (BoPH) in adult cigarette smokers (AS) who switched to using an e-vapor product (EVP) relative to adult smokers who continue smoking exclusively.
Primary Outcome
Summary of urine total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (ng/g) and absolute change from Baseline in Weeks 6 and 12 are presented (Study ALCS-RA-16-06-EV). Baseline / Visit 3 (Week 1) = Day 1 Visit 5 (Week 6) = Day 42 ± 3 Visit 7 (Week 12) = Day 84 ± 3 The first urine void of the day was collected at Visits 3, 5 and 7. Urine creatinine concentration was measured in the urine collection and used to adjust the urine biomarker concentration values as follows: Urine biomarker
Interventions
- OTHER Experimental: Test Product 1
- OTHER Experimental: Test Product 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2017-01-17 |
| Est. Completion | 2018-11-06 |
| Phase | NA |
What the finished NCT04800211 record still lists
NCT04800211 is an interventional study that assigns participants to a tested intervention. The registered 450 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 (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Experimental: Test Product 1 is the first listed.
NCT04800211 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04800211 about?
NCT04800211 is a clinical study titled "Biomarkers of Exposure and Biomarkers of Potential Harm in Adult Smokers Who Completely Switch to E-vapor Products". The purpose of this study was to estimate changes in biomarkers of exposure (BoE) and biomarkers of potential harm (BoPH) in adult cigarette smokers (AS) who switched to using an e-vapor product (EVP) relative to adult smokers who continue smoking exclusively.
What is the current status of trial NCT04800211?
This trial is currently completed. It is a NA study. The enrollment target is 450 participants. The study started on 2017-01-17. Estimated completion is 2018-11-06.
What interventions are being tested in trial NCT04800211?
The interventions under investigation include: Experimental: Test Product 1 (OTHER), Experimental: Test Product 2 (OTHER).
Who is sponsoring clinical trial NCT04800211?
This trial is sponsored by Altria Client Services, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04800211's enrollment target sits among peer trials
450 225th of 2000 higher than 1,768 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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