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Effects of Zolpidem CR® in Sleep and Heart Recovery in Cardiac Intensive Care Unit Patients

NCT01920334 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-08-12

No results posted yet for this study

Summary

A double blind, randomized, placebo-controlled study will be conducted in cardiac ICU patients who had been diagnosed with acute coronary syndrome, using a sleep promoting drug (zolpidem controlled release).

The study hypothesis is that sleeping better can improve the heart recovery in patients with a diagnosis of acute coronary syndrome.

Conditions

  • Acute Coronary Syndrome
  • Sleep Deprivation

Interventions

DRUG

Zolpidem CR 12.5mg

Patients will be given zolpidem CR 12.5mg each night for, at least, 3 consecutive nights, including the first night on the Cardiac ICU, when the undergo a full-night polysomnography

DRUG

Placebo

Patients will receive placebo pills at night, according to their usual sleep time, from the first night on the Cardiac ICU, until their hospital discharge

Sponsors & Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • Associação Fundo de Incentivo à Pesquisa

    lead OTHER

Principal Investigators

  • Patrick R Burke, MD · Associação Fundo de Incentivo à Pesquisa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2013-10-31
Completion
2014-01-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

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 NCT01920334 on ClinicalTrials.gov