Phase 2 Completed N=87 Randomized Quadruple-blind Treatment

Study of Cardiovascular Disease and Obstructive Sleep Apnea

Severe Obstructive Sleep Apnea (Apnea Hypopnea Index > 30 Events/Hour) · Hypertension

Source: ClinicalTrials.gov NCT01637623 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2020

Primary outcomePrimary: Change in Muscle Sympathetic Nerve Activity Responses During Hypoxia — -0.54; -0.84; -0.71; -0.69 bursts/minute*%SaO2

Summary

The purpose of this study is to determine if two medicines (allopurinol and losartan) can influence heart and blood vessel health compared to placebo in patients with sleep apnea who are using continuous positive airway pressure (CPAP).

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Muscle Sympathetic Nerve Activity Responses During Hypoxia	-0.54; -0.84; -0.71; -0.69; -0.66; -0.61	—
SECONDARY Change in Aortic Pulse Wave Velocity	-0.6; -0.03; 0.2	—
SECONDARY Cerebrovascular Conductance	0.32; 0.27; 0.33; 0.36; 0.31; 0.34	—
SECONDARY Forearm Vascular Conductance	0.41; 0.43; 0.49; 0.42; 0.55; 0.51	—
SECONDARY Change in Minute Ventilation at Normoxia	8.9; 9.3; 9.3; 8.9; 9.8; 8.8	—
SECONDARY Change in Minute Ventilation During Hypoxia	-0.41; -0.53; -0.44; -0.37; -0.43; -0.48	—
SECONDARY Aortic Augmentation Index	17.3; 18.8; 21.5; 16.1; 16.7; 22.5	—
SECONDARY Mean Change in PERCENT Vasodilation	1.38; 0.18; -1.06	—
SECONDARY Apnea-Hypopnea Index	46; 33; 35; 44; 45; 26	—
SECONDARY PERCENT Time Spent Below 88 PERCENT Oxygen Saturation	10; 5; 5; 12; 8; 3	—
SECONDARY Change in Mean 24-Hour Blood Pressure (Mean Arterial Pressure)	-4.73; -2.58; 1.02	—

Eligibility Criteria

Inclusion Criteria

Males and females between ages of 21 and 65 years
Apnea hypopnea index or respiratory disturbance index greater than or equal to 25 events per hour
Subjects eligible for CPAP or BiPAP therapy
Hypertension by clinical history/diagnosis (may be controlled with non- exclusionary medications) or average blood pressure > 140/90 mm Hg (using last two measurements in prior 12 months - or 1 prior blood pressure and 1 blood pressure at screening)

Exclusion Criteria

If subject not using CPAP, having AHI > 60 events/hour or oxygen saturation ≤ 65% during sleep
Presence of clinical CV disease (coronary artery disease, angina, arrhythmias (subjects with sinus arrhythmias will be reviewed by PI for enrollment), stroke, TIA, cor pulmonale, etc.), heart failure, bruits, or diabetes mellitus by clinical diagnosis/history
Presence of pulmonary disease that results in significant hypoxemia (resting SaO2 300 mg/dL), diabetes or impaired glucose tolerance (fasting plasma glucose > 125 mg/dL)
Patients taking angiotensin converting enzyme inhibitors, angiotensin receptor antagonists, potassium-sparing diuretics (without accompanying loop/thiazide diuretic), allopurinol, oxypurinol, febuxostat, amoxicillin, ampicillin, azathioprine or mercaptopurine.
Patients with chronic kidney disease (Serum creatinine >1.5 mg/dL) or history of significant hyperkalemia (Serum potassium > 5.2 mEq/L) with ARB therapy
Patients with history of angioedema
Patients with bilateral, modified radical or radical mastectomies
Patients who have a Serum potassium > 5.0 mEq/L at the screening visit
Female patients who are pregnant (determined by urine pregnancy test) or breastfeeding
Patients with active MRSA or VRE (vancomycin resistant enterococcus) infection
History of adverse reaction to allopurinol, losartan, or zolpidem**
Patients who cannot swallow oral capsules
Patients who are hospitalized or who have been recently hospitalized (last 2 weeks)
Inability to comply with or complete the protocol or other reasons at the discretion of the investigators

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01637623). 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. Informational only — not medical advice.