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NCT04535934 · ClinicalTrials.gov registry record
Novel Approaches for Quantitative Assessment of Adherence
A clinical trial, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- 15
- Enrollment target
NCT04535934 is a clinical trial that has completed, run by University of Colorado, Denver. The registered enrollment target is 15 participants.
The verdict
NCT04535934 has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- 15 participants
- Enrollment target
Study Summary
Approximately 12 adults subjects will be enrolled. Participants will be randomized to one of two directly observed dosing regimens with 2mg adenine 5+ (five stable-labeled nitrogens) as follows: 1 dose/week followed by 4 doses/week OR 3 doses/week followed by 7 doses/week. Each dose regimen will have a duration of approximately 12 weeks and will be separated by a 12-week washout period for a total study duration of approximately 36 weeks. Dried blood spots (DBS) and whole blood will be collect weekly. Urine will be collected less frequently, about every 2 weeks. The ratio of ATP 5+ to naturally occurring ATP 2+ is dried blood spots will be the primary outcome, as adenine is phosphorylated to ATP in red blood cells. Breakdown products will be measured in urine. Investigators will allow flexibility in terms of which days are used for dosing for the 1, 3, and 4 dose(s)/week regimens. This is scientifically justified as investigators expect a 20-30 day half-life of ATP 5+ in DBS.
Interventions
- OTHER Adenine 5+ (five stable-labeled nitrogens)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2020-08-31 |
| Est. Completion | 2022-11-15 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04535934
The ClinicalTrials.gov registry entry for NCT04535934 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Adenine 5+ (five stable-labeled nitrogens) is the first listed.
NCT04535934 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04535934 about?
NCT04535934 is a clinical study titled "Novel Approaches for Quantitative Assessment of Adherence". Approximately 12 adults subjects will be enrolled. Participants will be randomized to one of two directly observed dosing regimens with 2mg adenine 5+ (five stable-labeled nitrogens) as follows: 1 dose/week followed by 4 doses/week OR 3 doses/week followed by 7 doses/week. Each dose regimen will hav...
What is the current status of trial NCT04535934?
This trial is currently completed. The enrollment target is 15 participants. The study started on 2020-08-31. Estimated completion is 2022-11-15.
What interventions are being tested in trial NCT04535934?
The interventions under investigation include: Adenine 5+ (five stable-labeled nitrogens) (OTHER).
Who is sponsoring clinical trial NCT04535934?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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