Trial Outcomes & Findings for Mechanisms of Refractory Hypertension (Reserpine) (NCT NCT03223272)
NCT ID: NCT03223272
Last Updated: 2021-11-30
Results Overview
Twenty-four hour ambulatory systolic blood pressure
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Baseline and 8 weeks
Results posted on
2021-11-30
Participant Flow
Participant milestones
| Measure |
Reserpine
Subjects will receive open-label reserpine 0.1 mg daily for 4 weeks.
Reserpine: Open label reserpine 0.1 mg pill orally
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mechanisms of Refractory Hypertension (Reserpine)
Baseline characteristics by cohort
| Measure |
Reserpine
n=7 Participants
Subjects will receive open-label reserpine 0.1 mg daily for 4 weeks.
Reserpine: Open label reserpine 0.1 mg pill orally
|
|---|---|
|
Age, Continuous
|
49.5 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksTwenty-four hour ambulatory systolic blood pressure
Outcome measures
| Measure |
Reserpine
n=6 Participants
Subjects will receive open-label reserpine 0.1 mg daily for 4 weeks.
Reserpine: Open label reserpine 0.1 mg pill orally
|
|---|---|
|
Change Ambulatory Systolic Blood Pressure
|
-29.3 mmHg
Standard Deviation 22.2
|
Adverse Events
Reserpine
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Reserpine
n=7 participants at risk
Subjects will receive open-label reserpine 0.1 mg daily for 4 weeks.
Reserpine: Open label reserpine 0.1 mg pill orally
|
|---|---|
|
Cardiac disorders
NSTEMI
|
14.3%
1/7 • Number of events 1 • Baseline through 10 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place