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Study of Cardiovascular Disease and Obstructive Sleep Apnea

NCT01637623 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2020-08-14

Study results available
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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).

Conditions

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

Interventions

DRUG

Losartan

Losartan 50 mg daily for two weeks, then increased to 100mg daily for 4 weeks if asymptomatic. Remain at 50 mg daily for 4 more weeks or removed from study if symptomatic.

DRUG

Allopurinol

Allopurinol 300 mg daily for 6 weeks

DRUG

Placebo

Placebo capsule daily for 6 weeks

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • John Dopp, Pharm.D. · UW Madison School of Pharmacy

  • Barbara J Morgan, PhD, PT · UW Madison School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-06-30
Completion
2015-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01637623 on ClinicalTrials.gov