MedTrace Logo

Dose Ranging Study of Celivarone With Amiodarone as Calibrator for the Prevention of Implantable Cardioverter Defibrillator (ICD) Interventions or Death

NCT00993382 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 486

Last updated 2016-05-30

No results posted yet for this study

Summary

The Primary objective was to assess the efficacy of Celivarone for the prevention of Implantable Cardioverter Defibrillator (ICD) interventions or death.

Secondary objectives were:

* To assess the tolerability and safety of the different dose regimens of Celivarone in the selected population.
* To document Celivarone plasma levels during the study.

Conditions

  • Arrhythmia Prophylaxis
  • Ventricular Arrhythmia

Interventions

DRUG

Celivarone

Pharmaceutical form: capsule Route of administration: oral

DRUG

Amiodarone

Pharmaceutical form: capsule Route of administration: oral

DRUG

Matching placebo

Pharmaceutical form: capsule Route of administration: oral Matching placebo added to active drug if any for a total of 3 capsules per intake

Sponsors & Collaborators

Principal Investigators

  • Peter KOWEY, Pr · Steering Committee Chair Person

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Canada
  • Chile
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • South Africa
  • Spain
  • Sweden
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Companies

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 NCT00993382 on ClinicalTrials.gov