Trial Outcomes & Findings for Vascular Dysfunction in Human Obesity Hypertension (NCT NCT01983462)

NCT ID: NCT01983462

Last Updated: 2023-04-14

Results Overview

Carotid-femoral pulse wave velocity (PWV)

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 33 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2023-04-14

Participant Flow

Randomized to clonidine, HCTZ or placebo for 4 weeks

Participant milestones

Measure	Clonidine Oral 0.2 mg/day (0.1 mg bid)for 4 weeks Clonidine	Hydrochlorothiazide Oral, 12.5 mg/day qd, 4 weeks Hydrochlorothiazide	Placebo Placebo Placebo
Overall Study STARTED	11	11	11
Overall Study COMPLETED	10	11	11
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Measure	Clonidine Oral 0.2 mg/day (0.1 mg bid)for 4 weeks Clonidine	Hydrochlorothiazide Oral, 12.5 mg/day qd, 4 weeks Hydrochlorothiazide	Placebo Placebo Placebo
Overall Study Adverse Event	1	0	0

Baseline Characteristics

Vascular Dysfunction in Human Obesity Hypertension

Baseline characteristics by cohort

Measure	Clonidine n=11 Participants Oral 0.2 mg/day (0.1 mg bid)for 4 weeks Clonidine	Hydrochlorothiazide n=11 Participants Oral, 12.5 mg/day qd, 4 weeks Hydrochlorothiazide	Placebo n=11 Participants Placebo Placebo	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	11 Participants n=7 Participants	10 Participants n=5 Participants	31 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Age, Continuous	41 years STANDARD_DEVIATION 18 • n=5 Participants	31 years STANDARD_DEVIATION 10 • n=7 Participants	37 years STANDARD_DEVIATION 19 • n=5 Participants	35 years STANDARD_DEVIATION 16 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	8 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	25 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	11 Participants n=7 Participants	10 Participants n=5 Participants	31 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants	22 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	11 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants	33 Participants n=4 Participants

PRIMARY outcome

Timeframe: 4 weeks

Carotid-femoral pulse wave velocity (PWV)

Outcome measures

Measure	Clonidine n=10 Participants Oral 0.2 mg/day (0.1 mg bid)for 4 weeks Clonidine	Hydrochlorothiazide n=11 Participants Oral, 12.5 mg/day qd, 4 weeks Hydrochlorothiazide	Placebo n=11 Participants Placebo Placebo
Aortic Stiffness Baseline	7.9 meters/sec Standard Error 0.7	7.0 meters/sec Standard Error 0.4	8.1 meters/sec Standard Error 1.0
Aortic Stiffness 4 weeks	7.3 meters/sec Standard Error 0.6	7.0 meters/sec Standard Error 0.3	8.0 meters/sec Standard Error 1.2

SECONDARY outcome

Timeframe: 4 weeks

24 hour ambulatory systolic blood pressure

Outcome measures

Measure	Clonidine n=10 Participants Oral 0.2 mg/day (0.1 mg bid)for 4 weeks Clonidine	Hydrochlorothiazide n=11 Participants Oral, 12.5 mg/day qd, 4 weeks Hydrochlorothiazide	Placebo n=9 Participants Placebo Placebo
24 Hour Average Systolic Blood Pressure Baseline	133 mmHg Standard Error 3	135 mmHg Standard Error 2	133 mmHg Standard Error 2
24 Hour Average Systolic Blood Pressure 4 weeks	126 mmHg Standard Error 3	131 mmHg Standard Error 2	134 mmHg Standard Error 2

Adverse Events

Clonidine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Hydrochlorothiazide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Clonidine n=10 participants at risk Oral 0.2 mg/day (0.1 mg bid)for 4 weeks Clonidine	Hydrochlorothiazide n=11 participants at risk Oral, 12.5 mg/day qd, 4 weeks Hydrochlorothiazide	Placebo n=11 participants at risk Placebo Placebo
Cardiac disorders Mild hypotension	10.0% 1/10 • Number of events 1 • 4 weeks	0.00% 0/11 • 4 weeks	0.00% 0/11 • 4 weeks

Additional Information

Gary Pierce, PhD

University of Iowa

Phone: 3193359487

Email: gary-pierce@uiowa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place