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Tolerance to Target Doses of Thiazides in Actual Practice: A Feasibility Study

NCT01235377 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-11-25

Study results available
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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. 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

Interventions

OTHER

Favor one of two thiazides for new prescriptions & attempt target dose

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.

Sponsors & Collaborators

  • VA Pharmacy Benefits Management Strategic Healthcare Group

    lead FED

Principal Investigators

  • Madeline McCarren, PhD, MPH · VA Pharmacy Benefits Management

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-10-31
Completion
2014-02-28

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01235377 on ClinicalTrials.gov