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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04098003
The ClinicalTrials.gov registry entry for NCT04098003 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (87% lower). The listed sponsor is Sony Tuteja, which has 2 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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