HypertensionPhase 4NCT01235377
Tolerance to Target Doses of Thiazides in Actual Practice: A Feasibility Study
A Phase 4 study testing Favor one of two thiazides for new prescriptions & attempt target dose in people with Hypertension, run by VA Pharmacy Benefits Management Strategic Healthcare Group at 5 sites in United States.
Trial summary
This is a pilot study of a method to compare common, FDA-approved drugs in a clinic. Instead of putting single patients into one of two drug groups, the investigators will assign the doctors who prescribe these drugs for high blood pressure into two groups. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Favor one of two thiazides for new prescriptions & attempt target dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2011to Feb 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- VA prescribers of thiazides for hypertension
Who cannot join
- at non-participating VA sites
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Charles George VAMC
Asheville, North Carolina, 28805
WJB Dorn VA Medical Center
Columbia, South Carolina, 29209
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141
WJB Dorn VAMC/Columbia Orangeburg VA Outpatient Clinic
Orangeburg, South Carolina, 29118
Wilkes-Barre VA Medical Center
Wilkes-Barre, Pennsylvania, 18711
About this study
This is a pilot study of a method to compare common, FDA-approved drugs in a clinic. Instead of putting single patients into one of two drug groups, the investigators will assign the doctors who prescribe these drugs for high blood pressure into two groups. One group of doctors has agreed to prescribe mostly ("favor") one drug, chlorthalidone, if that drug would be a good choice for a patient. The other group has agreed to prescribe mostly hydrochlorothiazide. For both groups, they will try to use the doses that were shown to be protective in other trials. If the doctors mostly prescribe the drug they agreed to favor, the investigators will be able to compare outcomes, like heart attacks, in the two groups.
- Conditions
- Hypertension
- Being tested
- Favor one of two thiazides for new prescriptions & attempt target dose
- Keywords
- prescribing patterns, thiazide, chlorthalidone, hydrochlorothiazide, target dose, cluster randomized trial
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Favor one of two thiazides for new prescriptions & attempt target doseOther
Providers will be randomized to either Favor Chlorthalidone or Favor Hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension, whether the thiazide is 1st line or add-on therapy. Providers will have agreed to adhere to their assignment for patients for whom there is equipoise, but they are free to deviate if medically indicated for individual patients. There is no requirement to maintain the initial thiazide therapy; it is expected that the regimen may require adjustment over time. The cluster assignment is simply to favor a particular thiazide on initiation of thiazide therapy and attempt to reach the target dose.
| Study group | Role | What they receive |
|---|---|---|
| Favor Chlorthalidone | Active comparator | Providers randomized to Favor Chlorthalidone will have agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension, whether the thiazide is 1st line or add-on therapy. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients Receives: Other: Favor one of two thiazides for new prescriptions & attempt target dose |
| Favor Hydrochlorothiazide | Active comparator | Providers randomized to Favor Hydrochlorothiazide will have agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension, whether the thiazide is 1st line or add-on therapy. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients Receives: Other: Favor one of two thiazides for new prescriptions & attempt target dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prescription Rates
rates of provider prescribing of the Cluster Designated drug
Measured: nine months
Secondary outcomes (1)
Factors Associated With Prescribing Patterns
factors (barriers and facilitators) associated with prescribing according to the Cluster Designation
Measured: nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2010 (estimated)
- Study startSep 2011
- Primary completionOct 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Pharmacy Benefits Management Strategic Healthcare Group
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Madeline McCarren, VA Pharmacy Benefits Management Strategic Healthcare Group
- Investigators
- Madeline McCarren, PhD, MPH, Principal investigator, VA Pharmacy Benefits Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235377
- Sponsor's protocol ID
- VMS156
- Status last verified
- Nov 2014
- First submitted
- 4 Nov 2010
- Last updated
- 25 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance to Target Doses of Thiazides in Actual Practice: A Feasibility Study
- ClinicalTrials.gov ID
- NCT01235377
- Acronym / sponsor ID
- VMS156
- Conditions
- Hypertension
- Keywords
- prescribing patterns, thiazide, chlorthalidone, hydrochlorothiazide, target dose, cluster randomized trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- VA Pharmacy Benefits Management Strategic Healthcare GroupUS federal agency
- Study start
- Sep 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 5 Nov 2010 (estimated)
- Results
- Posted 25 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study of a method to compare common, FDA-approved drugs in a clinic. Instead of putting single patients into one of two drug groups, the investigators will assign the doctors who prescribe these drugs for high blood pressure into two groups. One group of doctors has agreed to prescribe mostly ("favor") one drug, chlorthalidone, if that drug would be a good choice for a patient. The other group has agreed to prescribe mostly hydrochlorothiazide. For both groups, they will try to use the doses that were shown to be protective in other trials. If the doctors mostly prescribe the drug they agreed to favor, the investigators will be able to compare outcomes, like heart attacks, in the two groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Favor Chlorthalidone | Active comparator | Other: Favor one of two thiazides for new prescriptions & attempt target doseProviders randomized to Favor Chlorthalidone will have agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension, whether the thiazide is 1st line or add-on therapy. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients |
| Favor Hydrochlorothiazide | Active comparator | Other: Favor one of two thiazides for new prescriptions & attempt target doseProviders randomized to Favor Hydrochlorothiazide will have agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension, whether the thiazide is 1st line or add-on therapy. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- VA prescribers of thiazides for hypertension
Key exclusion criteria (1 listed)
- at non-participating VA sites
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 |
|---|---|---|
| Favor one of two thiazides for new prescriptions & attempt target doseProviders will be randomized to either Favor Chlorthalidone or Favor Hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension, whether the thiazide is 1st line or add-on therapy. Providers will have agreed to adhere to their assignment for patients for whom there is equipoise, but they are free to deviate if medically indicated for individual patients. There is no requirement to maintain the initial thiazide therapy; it is expected that the regimen may require adjustment over time. The cluster assignment is simply to favor a particular thiazide on initiation of thiazide therapy and attempt to reach the target dose. | Other | Favor Chlorthalidone, Favor Hydrochlorothiazide |
Primary outcome
Prescription Rates
Time frame: nine months
rates of provider prescribing of the Cluster Designated drug
1 secondary outcome
Factors Associated With Prescribing Patterns
Time frame: nine months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Madeline McCarren, PhD, MPH principal investigator
VA Pharmacy Benefits Management
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Favor one of two thiazides for new prescriptions & attempt target dose in people with Hypertension, run by VA Pharmacy Benefits Management Strategic Healthcare Group at 5 sites in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 25 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Prescription Rates (time frame: nine months). 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 25 Nov 2014.