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Pharmocogenomic test assessment in the medication regimen and disease management for patients under drugs known with genetic variation.
Pharmocogenomic. A multicenter, observational study to evaluate the use of a Pharmocogenomic test assessment in the medication regimen and disease management for patients under drugs known to be influenced by genetic variation.
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| Measure | Description | Time Frame |
|---|---|---|
| Radar, Pharmocogenomic | The primary endpoint of the study is the binary occurrence of meaningful change in drug regimen, defined in each patient when:
Change in drug dose, substitution, or discontinuation among patients with an identified genotype known to affect a drug the patient is taking as directed. This will be assessed by a quantitative survey. | The period of enrollment is anticipated to be 36 months with a 120- day follow-up period, for total study duration of approximately 40 months from first patient enrolled to completion of follow-up on the last patient in. |
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INCLUSION CRITERIA
Patients may be included in the Study if they meet all of the following inclusion criteria:
EXCLUSION CRITERIA
Patients will be excluded from the Study if any of the following criteria apply:
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Patients who are under treatment with several drugs with any of the sequences of biochemical reactions, catalyzed by enzymes, known to be influenced by genetic variation in a patient population.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diana Messir | Contact | 239-908-0412 | Diana@integritycro.com | |
| Diana M Messir | Contact | 239-908-0412 | Diana.M@Radar-PGxStudy.com |
| Name | Affiliation | Role |
|---|---|---|
| Haleh Farzanmehr, MD | GXL | Principal Investigator |
| Haleh Farzanmehr, MD | GXL | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD@Home | Recruiting | York | Pennsylvania | 17402 | United States |
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