Reduction of Adverse Drug Events and Readmissions (RADAR-PGX)
This study is currently recruiting participants.
Verified May 2017 by MD Global, Inc.
Information provided by (Responsible Party):
MD Global, Inc.
First received: March 28, 2016
Last updated: May 18, 2017
Last verified: May 2017
Pharmocogenomic test assessment in the medication regimen and disease management for patients under drugs known with genetic variation.
Pharmacogenomic Testing for Medication Management
||Observational Model: Other
Time Perspective: Other
|Target Follow-Up Duration:
||Pharmacogenomic Test Assessment for Medication Management in the Advancement of Medicine
Primary Outcome Measures:
- Radar, Pharmocogenomic [ Time Frame: 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. ]
The primary endpoint of the study is the binary occurrence of meaningful change in drug regimen, defined in each patient when:
- A genotype known to affect a drug the patient is taking is identified, *and*
- The patient's treating physician makes at least one target drug regimen change, dose, substitution, or discontinuation.
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.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2019 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||25 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
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.
Patients may be included in the Study if they meet all of the following inclusion criteria:
- Male or female patients of 25 years of age or older who are able to give their written Informed Consent to participate in a Clinical Study based on voluntary agreement with a thorough explanation of the patient's participation will be provided to them.
- Patient underwent PGx testing for alleles appropriate to the target drugs within the prior 120 days ("index PGx test assessment");
- Patient was receiving at least one medication known to be associated with allelic variation at the time of the ("index PGx test assessment"), including over-the- counter medications;
- Patient has a history of at least one TDAE over the 24-month period preceding the PGx test assessment, or has experienced inadequate efficacy from a target drug.
Patients will be excluded from the Study if any of the following criteria apply:
- Patient is currently hospitalized;
- Patient's medical and medication history is unavailable over the 120-day period preceding the PGx test assessment;
- Patient is unable to provide an accurate history due to mental Incapacity;
- Patient is known to have undergone prior PGx testing for genes specific to the target drug(s), exclusive of the PGx test relating to this Study.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02738047
|York, Pennsylvania, United States, 17402 |
|Contact: Marv Inscore 717-840-8686 |
MD Global, Inc.
||Donald Mansfield, MD
||Michael Cohen, PHD
||Clinical Research for Professionals
ClinicalTrials.gov processed this record on June 28, 2017
||MD Global, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 28, 2016
||May 18, 2017
|Individual Participant Data
|Plan to Share IPD: