Trial Outcomes & Findings for Treatment of OSA Associated Hypertension With Alpha 2 Agonist or Diuretic (NCT NCT02699125)

Last Updated: 2020-12-04

Results Overview

The primary outcome measure is ambulatory systolic and diastolic blood pressure recorded once every 15 minutes during the day and once every 30 minutes during the sleep. The Outcome Measure Data Table present primary outcome as "24-h", "Wake" and "Sleep" Period Systolic and Diastolic Blood Pressure after each of the following three interventions: Placebo, Guanfacine and Hydrochlorothiazide.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

41 participants

Primary outcome timeframe

At the end of 2 weeks of placebo therapy, at the end of 6 weeks of guanfacine therapy and at the end of 6 weeks of hydrochlorothiazide therapy.

Results posted on

2020-12-04

Participant Flow

405 participants were screened for eligibility.

41 participant was enrolled in the study.

Participant milestones

Participant milestones
Measure	Placebo, Then Guanfacine, Then Hydrochlorothiazide Participants first received Placebo for 2 weeks. They then received guanfacine 1 mg for 2 weeks followed by guanfacine 2 mg for 4 weeks. They then received hydrochlotothyazide 12.5 mg for 2 weeks followed by hydrochlorothyazied 25 mg for 4 weeks.	Placebo, Then Hydrochlorothiazide Then Guanfacine. Participants first received Placebo for 2 weeks. They then received hydrochlotothyazide 12.5 mg for 2 weeks followed by hydrochlorothyazied 25 mg for 4 weeks. They then received guanfacine 1 mg for 2 weeks followed by guanfacine 2 mg for 4 weeks.
Placebo STARTED	21	20
Placebo COMPLETED	18	16
Placebo NOT COMPLETED	3	4
First Intervention (6 Weeks). STARTED	18	16
First Intervention (6 Weeks). COMPLETED	18	16
First Intervention (6 Weeks). NOT COMPLETED	0	0
Second Intervention (6 Weeks). STARTED	18	16
Second Intervention (6 Weeks). COMPLETED	11	14
Second Intervention (6 Weeks). NOT COMPLETED	7	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo, Then Guanfacine, Then Hydrochlorothiazide Participants first received Placebo for 2 weeks. They then received guanfacine 1 mg for 2 weeks followed by guanfacine 2 mg for 4 weeks. They then received hydrochlotothyazide 12.5 mg for 2 weeks followed by hydrochlorothyazied 25 mg for 4 weeks.	Placebo, Then Hydrochlorothiazide Then Guanfacine. Participants first received Placebo for 2 weeks. They then received hydrochlotothyazide 12.5 mg for 2 weeks followed by hydrochlorothyazied 25 mg for 4 weeks. They then received guanfacine 1 mg for 2 weeks followed by guanfacine 2 mg for 4 weeks.
Placebo Lost to Follow-up	2	0
Placebo Protocol Violation	1	0
Placebo Withdrawal by Subject	0	4
Second Intervention (6 Weeks). Withdrawal by Subject	7	2

Baseline Characteristics

The Overall Number of Participants Analyzed (18) differs from the Overall Number of Baseline Participants (21) because brachial artery flow mediated dilation data for 3 participants were excluded due to low quality of the ultrasound images.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=21 Participants "Placebo" column have 6 rows of baseline Primary Outcome Values: "24-h", "Wake" and "Sleep" Systolic and Diastolic Blood Pressure. "Placebo" column also have 1 row of baseline Secondary Outcome Value: Brachial Artery Flow Mediated Dilation.
Age, Categorical <=18 years	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=21 Participants
Age, Categorical >=65 years	3 Participants n=21 Participants
Age, Continuous	52 years STANDARD_DEVIATION 11 • n=21 Participants
Sex: Female, Male Female	3 Participants n=21 Participants
Sex: Female, Male Male	18 Participants n=21 Participants
Region of Enrollment United States	21 participants n=21 Participants
24-h, Wake and Sleep Period Systolic and Diastolic Blood Pressure 24-h systolic blood pressure	143 mmHg STANDARD_DEVIATION 19 • n=21 Participants
24-h, Wake and Sleep Period Systolic and Diastolic Blood Pressure 24-h diastolic blood pressure	87 mmHg STANDARD_DEVIATION 11 • n=21 Participants
24-h, Wake and Sleep Period Systolic and Diastolic Blood Pressure Wake systolic blood pressure	147 mmHg STANDARD_DEVIATION 20 • n=21 Participants
24-h, Wake and Sleep Period Systolic and Diastolic Blood Pressure Wake diastolic blood pressure	91 mmHg STANDARD_DEVIATION 12 • n=21 Participants
24-h, Wake and Sleep Period Systolic and Diastolic Blood Pressure Sleep systolic blood pressure	136 mmHg STANDARD_DEVIATION 20 • n=21 Participants
24-h, Wake and Sleep Period Systolic and Diastolic Blood Pressure Sleep diastolic blood pressure	80 mmHg STANDARD_DEVIATION 11 • n=21 Participants
Brachial Artery Flow Mediated Dilation	4.5 percent STANDARD_DEVIATION 3 • n=18 Participants • The Overall Number of Participants Analyzed (18) differs from the Overall Number of Baseline Participants (21) because brachial artery flow mediated dilation data for 3 participants were excluded due to low quality of the ultrasound images.

PRIMARY outcome

Timeframe: At the end of 2 weeks of placebo therapy, at the end of 6 weeks of guanfacine therapy and at the end of 6 weeks of hydrochlorothiazide therapy.

Outcome measures

Outcome measures
Measure	Placebo n=21 Participants Placebo for 2 weeks	Guanfacine n=21 Participants Guanfacine 1 mg for 2 weeks followed by guanfacine 2 mg for 4 weeks.	Hydrochlorothyazide n=21 Participants Hydrochlorothyazide 12.5 mg for 2 weeks followed by hydrochlorothyazide 25 mg for 4 weeks.
24-h, Wake and Sleep Period Systolic and Diastolic Blood Pressure 24-h systolic blood pressure	143 mmHg Standard Error 4.2	133 mmHg Standard Error 2.9	136 mmHg Standard Error 3.5
24-h, Wake and Sleep Period Systolic and Diastolic Blood Pressure 24-h diastolic blood pressure	87 mmHg Standard Error 2.5	81 mmHg Standard Error 2	83 mmHg Standard Error 2.3
24-h, Wake and Sleep Period Systolic and Diastolic Blood Pressure Wake systolic blood pressure	147 mmHg Standard Error 4.4	137 mmHg Standard Error 3.1	139 mmHg Standard Error 3.9
24-h, Wake and Sleep Period Systolic and Diastolic Blood Pressure Wake diastolic blood pressure	91 mmHg Standard Error 2.7	84 mmHg Standard Error 1.9	86 mmHg Standard Error 2.5
24-h, Wake and Sleep Period Systolic and Diastolic Blood Pressure Sleep systolic blood pressure	136 mmHg Standard Error 4.3	124 mmHg Standard Error 2.6	130 mmHg Standard Error 3.4
24-h, Wake and Sleep Period Systolic and Diastolic Blood Pressure Sleep diastolic blood pressure	80 mmHg Standard Error 2.4	73 mmHg Standard Error 2.3	76 mmHg Standard Error 2.3

SECONDARY outcome

Timeframe: At the end of 2 weeks of placebo therapy, at the end of 6 weeks of guanfacine therapy and at the end of 6 weeks of hydrochlorothiazide therapy.

Brachial Artery Flow Mediated Dilation is upper arm brachial artery dilation during the 3 minutes forearm reactive hyperemia following the release of the 5-minute forearm cuff occlusion.

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants Placebo for 2 weeks	Guanfacine n=18 Participants Guanfacine 1 mg for 2 weeks followed by guanfacine 2 mg for 4 weeks.	Hydrochlorothyazide n=18 Participants Hydrochlorothyazide 12.5 mg for 2 weeks followed by hydrochlorothyazide 25 mg for 4 weeks.
Brachial Artery Flow Mediated Dilation	4.5 percentage of the preoclussion diameter Standard Error 0.8	8.4 percentage of the preoclussion diameter Standard Error 1.1	4.9 percentage of the preoclussion diameter Standard Error 0.7

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Guanfacine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hydrochlorothiazide

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

Michael G. Ziegler, M.D.

University of California San Diego

Phone: 619 543 2885

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place