Phase 4 N=41 Randomized Triple-blind Treatment

Treatment of OSA Associated Hypertension With Alpha 2 Agonist or Diuretic

Obstructive Sleep Apnea

Bottom Line

View on ClinicalTrials.gov: NCT02699125 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2020

Primary outcome: Primary: 24-h, Wake and Sleep Period Systolic and Diastolic Blood Pressure — 143; 133; 136; 87 mmHg

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Guanfacine (Drug); Hydrochlorothiazide (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: University of California, San Diego
Primary completion: Jun 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY 24-h, Wake and Sleep Period Systolic and Diastolic Blood Pressure	143; 133; 136; 87; 81; 83	—
SECONDARY Brachial Artery Flow Mediated Dilation	4.5; 8.4; 4.9	—

Summary

Patients who have obstructive sleep apnea (OSA) frequently stop breathing while they sleep. They often develop high blood pressure. We are not sure what drug is best to treat the high blood pressure. This study will give the patients guanfacine or hydrochlorothiazide (HCTZ) for 6 weeks after 2 weeks of placebo. The blood pressure response will be evaluated by 24 hour monitoring.

Eligibility Criteria

Inclusion Criteria

Patients ranging from 20 - 80 years
Body mass index (BMI) of 20-38 to include the typical obese OSA patients and avoid the practical difficulties in blood drawing from the massively obese
Hypertension with blood pressures > 140/90 but less than 180/105 mmHg.
Apnea-hypopnea index above 10

Exclusion Criteria

Receiving medications other than anti-hypertensives known to influence the sympathetic nervous system, sleep medicines (including heavy alcohol use) or drugs with adverse interactions with study medication.
Women who have premenstrual syndrome, or those who are pregnant or capable of pregnancy and unwilling to use effective non-hormonal contraception
Shift workers or have symptoms of narcolepsy, restless legs syndrome or insomnia, in order to minimize confounding effects of other sleep disorders
Have apneas which are primarily central
Have sleep fragmentation caused by syndromes such as chronic pain or movement disorders
Have diseases such as asthma or chronic obstructive pulmonary disease that compromises respiration.
Have known coronary or cerebral vascular disease, history of arrhythmias, cardiomyopathy, history of psychosis, current alcohol or drug abuse.
Have any contraindications to any study materials, such as heart block.
Have secondary hypertension
Have creatinine levels above 2.5 mg %, more than 1+ proteinuria by dipstick, hematuria or electrolyte disorders.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02699125). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.