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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: Completed NA study, sponsored by Indiana University.

NCT02297126 is a NA study that has completed, run by Indiana University. The registered enrollment target is 4,465 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (218% higher). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Analysis of cost of care (measured in U.S. dollars) data from the Eskenazi and Indiana University Health electronic medical records and billing systems for patients in the study. Charge data collected from monthly Eskenazi and IU Health System reports generated for the state hospital association. Categories of inpatient and outpatient charges include costs for medications, facility, laboratory, treatment, professional, and other sources. Data will be collected for each patient in the control and

Interventions

  • OTHER Pharmacogenetic Intervention Arm (pharmacogenetic testing)

Trial Details

FieldValue
Enrollment Target 4,465 participants
Start Date 2015-03
Est. Completion 2019-05-03
Phase NA
Indiana University

890 total trials

What the finished NCT02297126 record still lists

NCT02297126 is an interventional study that assigns participants to a tested intervention. Its 4,465 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (218% higher).

The record links to 0 conditions, and to 1 intervention - of which Pharmacogenetic Intervention Arm (pharmacogenetic testing) is the first listed.

NCT02297126 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02297126's enrollment target sits among peer trials

4,465 30th of 2000 higher than 1,971 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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Source: ClinicalTrials.gov NCT02297126, the US trial registry maintained by the National Library of Medicine. NCT02297126 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.