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NCT01300013 · ClinicalTrials.gov registry record · Phase 2

Study to Evaluate the Safety and Efficacy of IV Infusion Treatment With Omecamtiv Mecarbil in Subjects With Left Ventricular Systolic Dysfunction Hospitalized for Acute Heart Failure (ATOMIC-AHF)

A Phase 2 study of Heart Failure, sponsored by Cytokinetics.

Completed
Registry status
Phase 2
Development phase
614
Enrollment target
20
Study locations

NCT01300013 is a Phase 2 study of Heart Failure that has completed, run by Cytokinetics. The registered enrollment target is 614 participants, below the 2,047-participant average among 397 other Heart Failure trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT01300013, a Phase 2 study of Heart Failure, has completed, sponsored by Cytokinetics.

COMPLETED
Registry status
Phase 2
Development phase
614 participants
Enrollment target
20
Study locations

Study Summary

The primary objective of the study is to evaluate the effect of 48 hours of intravenous (IV) omecamtiv mecarbil compared with placebo on dyspnea in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure. This is a multicenter, randomized, double-blind, placebo-controlled study with 3 dose cohorts enrolled sequentially in order of ascending dose strength of omecamtiv mecarbil. In each cohort, subjects are randomized 1:1 to omecamtiv mecarbil or placebo.

Conditions Studied

Heart Failure

Interventions

  • DRUG Placebo
  • DRUG Omecamtiv mecarbil

Study Locations (20)

Florida

  • Research Site - Atlantis
  • Research Site - Clearwater
  • Research Site - Fort Lauderdale
  • Research Site - Miami
  • Research Site - Orlando

California

  • Research Site - Inglewood
  • Research Site - La Jolla
  • Research Site - San Francisco

Michigan

  • Research Site - Detroit
  • Research Site - Detroit
  • Research Site - Novi

Illinois

  • Research Site - Chicago
  • Research Site - Peoria

Alabama

  • Research Site - Mobile

Connecticut

  • Research Site - Danbury

Delaware

  • Research Site - Newark

Georgia

  • Research Site - Atlanta

Trial Details

FieldValue
Enrollment Target 614 participants
Start Date 2011-04
Est. Completion 2013-09
Phase Phase 2

Sponsor

Cytokinetics

31 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01300013

The ClinicalTrials.gov registry entry for NCT01300013 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 614 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,047-participant average among 397 other Heart Failure trials with a reported enrollment target (70% lower). The listed sponsor is Cytokinetics, which has 31 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01300013 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, California, Michigan.

Frequently Asked Questions

What is clinical trial NCT01300013 about?

NCT01300013 is a clinical study titled "Study to Evaluate the Safety and Efficacy of IV Infusion Treatment With Omecamtiv Mecarbil in Subjects With Left Ventricular Systolic Dysfunction Hospitalized for Acute Heart Failure (ATOMIC-AHF)". The primary objective of the study is to evaluate the effect of 48 hours of intravenous (IV) omecamtiv mecarbil compared with placebo on dyspnea in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure. This is a multicenter, randomized, double-blind, placebo-contr...

What is the current status of trial NCT01300013?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 614 participants. The study started on 2011-04. Estimated completion is 2013-09.

What conditions does trial NCT01300013 study?

This clinical trial studies the following conditions: Heart Failure.

What interventions are being tested in trial NCT01300013?

The interventions under investigation include: Placebo (DRUG), Omecamtiv mecarbil (DRUG).

Who is sponsoring clinical trial NCT01300013?

This trial is sponsored by Cytokinetics, which has 31 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01300013 being conducted?

This trial has 20 study locations across Alabama, California, Connecticut, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.