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NCT02297126 · ClinicalTrials.gov registry record · NA
A Prospective Trial to Assess Cost and Clinical Outcomes of a Clinical Pharmacogenomic Program
A NA study, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 4,465
- Enrollment target
NCT02297126 is a NA study that has completed, run by Indiana University. The registered enrollment target is 4,465 participants.
The verdict
NCT02297126, a NA study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 4,465 participants
- Enrollment target
Study Summary
The INGenious trial will prospectively enroll a total of 6,000 patients, with 2,000 patients assigned to a pharmacogenetic testing arm and 4,000 to a control arm who will be followed, but not tested. It is randomized between an intervention arm and one that receives no intervention in order that the genotyped group can be compared with one in which undisturbed, routine clinical care is carried out in patients taking the same drugs. Both arms will be followed for a year after being prescribed a targeted medication. Patients randomized into the intervention arm that are prescribed one or more of the 24 targeted index medication will receive pharmacogenomic testing using a custom micro-array measuring 51 Single nucleotide polymorphisms in 16 genes. The study is being conducted by the Indiana University School of Medicine and the Indiana University Institute of Personalized Medicine in collaboration with the Eskenazi and Indiana University Health Systems and will evaluate the economic and clinical outcomes associated with embedding a pharmacogenomics program in a system that serves as the primary health care safety-net in Indianapolis, Indiana. By successfully implementing a pharmacogenomics program and integrating it with the Electronic Health Record and Clinical Decision Support system, physicians will be able to optimize patient care by delivering tailored therapeutic decisions based on the patient's individual genetics.
Interventions
- OTHER Pharmacogenetic Intervention Arm (pharmacogenetic testing)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,465 participants |
| Start Date | 2015-03 |
| Est. Completion | 2019-05-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02297126
The ClinicalTrials.gov registry entry for NCT02297126 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 4,465 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pharmacogenetic Intervention Arm (pharmacogenetic testing) is the first listed.
NCT02297126 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02297126 about?
NCT02297126 is a clinical study titled "A Prospective Trial to Assess Cost and Clinical Outcomes of a Clinical Pharmacogenomic Program". The INGenious trial will prospectively enroll a total of 6,000 patients, with 2,000 patients assigned to a pharmacogenetic testing arm and 4,000 to a control arm who will be followed, but not tested. It is randomized between an intervention arm and one that receives no intervention in order that the...
What is the current status of trial NCT02297126?
This trial is currently completed. It is a NA study. The enrollment target is 4,465 participants. The study started on 2015-03. Estimated completion is 2019-05-03.
What interventions are being tested in trial NCT02297126?
The interventions under investigation include: Pharmacogenetic Intervention Arm (pharmacogenetic testing) (OTHER).
Who is sponsoring clinical trial NCT02297126?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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