Trial Outcomes & Findings for Management of Uncontrolled Hypertension (HTN) (NCT NCT02922023)
NCT ID: NCT02922023
Last Updated: 2022-12-02
Results Overview
changes in blood pressure from baseline vs after 1 month of change in drug therapy for each patient. Measured by T-test
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
2 participants
Primary outcome timeframe
Changes between Baseline and 1 month
Results posted on
2022-12-02
Participant Flow
Participant milestones
| Measure |
Chronotherapy
Chronotherapy group automatically receives a shift in 1 anti-hypertensive medication to night-time without assessment of ambulatory blood pressure monitor results.
Chronotherapy: Chronotherapy group will receive a shift in the timing of one of their antihypertensive medications to nighttime dosing without consulting their ABPM results.
|
ABPM
ABPM group will have their ambulatory blood pressure monitor results reviewed prior to deciding to change regimen.
Ambulatory blood pressure monitor (ABPM): ABPM allows providers to obtain blood pressure readings over a 24 hour period, to assess blood pressure at night to determine "dipping" status, and to evaluate the efficacy of anti-hypertensive therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Chronotherapy
Chronotherapy group automatically receives a shift in 1 anti-hypertensive medication to night-time without assessment of ambulatory blood pressure monitor results.
Chronotherapy: Chronotherapy group will receive a shift in the timing of one of their antihypertensive medications to nighttime dosing without consulting their ABPM results.
|
ABPM
ABPM group will have their ambulatory blood pressure monitor results reviewed prior to deciding to change regimen.
Ambulatory blood pressure monitor (ABPM): ABPM allows providers to obtain blood pressure readings over a 24 hour period, to assess blood pressure at night to determine "dipping" status, and to evaluate the efficacy of anti-hypertensive therapy.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Management of Uncontrolled Hypertension (HTN)
Baseline characteristics by cohort
| Measure |
Chronotherapy
n=2 Participants
Chronotherapy group automatically receives a shift in 1 anti-hypertensive medication to night-time without assessment of ambulatory blood pressure monitor results.
Chronotherapy: Chronotherapy group will receive a shift in the timing of one of their antihypertensive medications to nighttime dosing without consulting their ABPM results.
|
ABPM
ABPM group will have their ambulatory blood pressure monitor results reviewed prior to deciding to change regimen.
Ambulatory blood pressure monitor (ABPM): ABPM allows providers to obtain blood pressure readings over a 24 hour period, to assess blood pressure at night to determine "dipping" status, and to evaluate the efficacy of anti-hypertensive therapy.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Age, Continuous
|
71.5 years
STANDARD_DEVIATION 5.5 • n=99 Participants
|
—
|
71.5 years
STANDARD_DEVIATION 5.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
—
|
2 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Changes between Baseline and 1 monthPopulation: Data were not collected for either subject as they both withdrew from the study.
changes in blood pressure from baseline vs after 1 month of change in drug therapy for each patient. Measured by T-test
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 monthPopulation: Data were not collected for either subject as they both withdrew from the study.
Measured using Chi-square test or Fisher's Exact Test
Outcome measures
Outcome data not reported
Adverse Events
Chronotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ABPM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Katherine Vogel Anderson, Pharm.D., BCACP, FCCP
University of Florida Colleges of Pharmacy and Medicine
Phone: 352-273-6240
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place