Medication ManagementNCT02559193
Pharmacogenetic Testing for Medication Management.
An observational study of Medication Management, run by First Vitals LLC.
Trial summary
The Study is a single-arm prospective trial of patients receiving at least one medication with a known association between genetics and drug metabolism. All patients will undergo genetic testing as determined by their treating physician. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Management
- What is being tested?
- Observational study, data collection only trial.
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to May 2018
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The Study will include male or female patients 18 years of or older who are receiving at least one medication with metabolism known to depend on genetic variation and have the PGx test already performed. The patient must also meet the inclusion/ exclusion criteria established by the protocol.
Who may be able to join
- Patient underwent PGx testing for alleles appropriate to the target drugs within the prior 90 days ("index PGx test");
- Male or female patients 18 years or older who have given their written Informed Consent to participate in a Clinical Study based on voluntary agreement a through explanation of the patient's participation is provided to them. Patients must have adequate reading and writing abilities such that they can comprehend and answer the questions on the patient- completed assessments and Informed Consent Form;
- Patient was receiving at least one medication known to be associated with allelic variation at the time of the index PGx test), including over-the-counter medications;
- 5. Patient has a history of at least one TDAE over the 12-month period preceding receipt of PGx test results, or has experienced inadequate efficacy from a target drug and receiving medical coverage through a private insurance.
Who cannot join
- Patient is currently hospitalized;
- Patient's medical and medication history is unavailable over the 90-day period preceding the receipt of PGx testing;
- 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.
About this study
Official title: Medication Interactions to Detect Adverse Situations
The Study is a single-arm prospective trial of patients receiving at least one medication with a known association between genetics and drug metabolism. All patients will undergo genetic testing as determined by their treating physician. The specific genes tested will, in general, be based upon the drugs the patients are taking or those that the patient's treating physician is considering as potential substitutes for current medications.
Read the detailed description
In this data collection only trial design, the PGx test is not a protocol-specified procedure. Rather, patients are eligible if they have undergone PGx testing within the last 90 days. Thus, PGx testing will not be performed solely for inclusion in this clinical research initiative.
- Conditions
- Medication Management
- Being tested
- Observational study, data collection only trial.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study, data collection only trial.Other
Data collection only trial design.
| Study group | Role | What they receive |
|---|---|---|
| No treatment. | Data collection only trial design. Receives: Other: Observational study, data collection only trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the Study is the binary occurrence of meaningful change in drug regimen.
Measured: 90-day period following receipt of PGx test results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startJan 2016
- Primary completionMay 2018
- Study completionMay 2018
Why it stopped: Loss of funding for the continuation of the Study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- First Vitals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ernie Lee, CHRS, Study director, First Vitals LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559193
- Sponsor's protocol ID
- MIDAS
- Status last verified
- Jul 2019
- First submitted
- 22 Sep 2015
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Interactions to Detect Adverse Situations
- ClinicalTrials.gov ID
- NCT02559193
- Acronym / sponsor ID
- MIDAS
- Conditions
- Medication Management
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Loss of funding for the continuation of the Study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- First Vitals LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Study is a single-arm prospective trial of patients receiving at least one medication with a known association between genetics and drug metabolism. All patients will undergo genetic testing as determined by their treating physician. The specific genes tested will, in general, be based upon the drugs the patients are taking or those that the patient's treating physician is considering as potential substitutes for current medications.
Detailed description
In this data collection only trial design, the PGx test is not a protocol-specified procedure. Rather, patients are eligible if they have undergone PGx testing within the last 90 days. Thus, PGx testing will not be performed solely for inclusion in this clinical research initiative.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment. | – | Other: Observational study, data collection only trial.Data collection only trial design. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Study will include male or female patients 18 years of or older who are receiving at least one medication with metabolism known to depend on genetic variation and have the PGx test already performed. The patient must also meet the inclusion/ exclusion criteria established by the protocol.
Key inclusion criteria (4 listed)
- Patient underwent PGx testing for alleles appropriate to the target drugs within the prior 90 days ("index PGx test");
- Male or female patients 18 years or older who have given their written Informed Consent to participate in a Clinical Study based on voluntary agreement a through explanation of the patient's participation is provided to them. Patients must have adequate reading and writing abilities such that they can comprehend and answer the questions on the patient- completed assessments and Informed Consent Form;
- Patient was receiving at least one medication known to be associated with allelic variation at the time of the index PGx test), including over-the-counter medications;
- 5. Patient has a history of at least one TDAE over the 12-month period preceding receipt of PGx test results, or has experienced inadequate efficacy from a target drug and receiving medical coverage through a private insurance.
Key exclusion criteria (4 listed)
- Patient is currently hospitalized;
- Patient's medical and medication history is unavailable over the 90-day period preceding the receipt of PGx testing;
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study, data collection only trial.Data collection only trial design. | Other | No treatment. |
Primary outcome
The primary endpoint of the Study is the binary occurrence of meaningful change in drug regimen.
Time frame: 90-day period following receipt of PGx test results
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
Related trials for Medication Management
Not yet recruitingObservational study
Development and Prospective Validation of the AutoEIT Foundation Model for ARDS
ARDS (Acute Respiratory Distress Syndrome), Respiratory Failure
Recruiting
Effects of Cartoons & Interactive Storytelling on Fear and Comfort in 6-9 Year Olds During Nebulizer Treatment
Distraction Methods, Nursing Care
Recruiting
IMB-Guided Health Education Intervention for Medication Adherence and Blood Pressure Control in Non-adherent Hypertensive Patients
Hypertension
RecruitingObservational study
Reduction of Adverse Drug Events and Readmissions
Pharmacogenomic Testing for Medication Management
Recruiting
ASCEND-1: Lifestyle Intervention Plus Mazdutide for Weight Management
Obesity, Weight Control
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernie Lee, CHRS study director
First Vitals LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Management, run by First Vitals LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of the Study is the binary occurrence of meaningful change in drug regimen. (time frame: 90-day period following receipt of PGx test results). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2019.