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NCT04098003 · ClinicalTrials.gov registry record · Phase 4
Investigation of the Gut Microbiome and Statin Response
A Phase 4 study of Healthy Volunteers, sponsored by Sony Tuteja.
- Active
- Registry status
- Phase 4
- Development phase
- 62
- Enrollment target
- 1
- Study location
NCT04098003: Active Phase 4 study of Healthy Volunteers, sponsored by Sony Tuteja.
NCT04098003 is a Phase 4 study of Healthy Volunteers that is active but no longer recruiting, run by Sony Tuteja. The registered enrollment target is 62 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04098003, a Phase 4 study of Healthy Volunteers, is active but no longer recruiting, sponsored by Sony Tuteja.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 62 participants
- Enrollment target
- 1
- Study location
Study Summary
There is evidence that the bacteria that naturally reside in the gut can influence how well we respond to medications. Therefore this study will look at how rosuvastatin, a medication used to lower cholesterol levels, may change the bacteria in the gut. Investigators will also examine how the gut bacteria will affect the ability of rosuvastatin to lower cholesterol levels. There will be 4 study visits over the course of about 16 weeks.The expected duration of the study is 2 years. Investigators plan to enroll 100 healthy volunteers during that time.
Primary Outcome
Change in relative abundance (8 weeks - baseline) = The percentage of total sequenced microbial reads assigned to a bacterial taxon (based on log 10 transformed values) at baseline were subtracted from the percentage of total sequenced microbial reads assigned to a taxon at 8 weeks. Negative values signify that the % of reads belonging to a particular species is decreasing.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Rosuvastatin
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Phildelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2020-02-06 |
| Est. Completion | 2026-03-01 |
| Phase | Phase 4 |
What the registry record for NCT04098003 still lists
NCT04098003 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04098003 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04098003 about?
NCT04098003 is a clinical study titled "Investigation of the Gut Microbiome and Statin Response". There is evidence that the bacteria that naturally reside in the gut can influence how well we respond to medications. Therefore this study will look at how rosuvastatin, a medication used to lower cholesterol levels, may change the bacteria in the gut. Investigators will also examine how the gut ba...
What is the current status of trial NCT04098003?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 62 participants. The study started on 2020-02-06. Estimated completion is 2026-03-01.
What conditions does trial NCT04098003 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT04098003?
The interventions under investigation include: Placebo (DRUG), Rosuvastatin (DRUG).
Who is sponsoring clinical trial NCT04098003?
This trial is sponsored by Sony Tuteja, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04098003 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Volunteers
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04098003's enrollment target sits among peer trials
62 107th of 283 higher than 176 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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.
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