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

Target enrollment

2 participants

Primary outcome timeframe

Changes between Baseline and 1 month

Results posted on

2022-12-02

Participant Flow

Participant milestones

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

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

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=5 Participants	—	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Age, Continuous	71.5 years STANDARD_DEVIATION 5.5 • n=5 Participants	—	71.5 years STANDARD_DEVIATION 5.5 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	—	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Changes between Baseline and 1 month

Population: 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 month

Population: 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