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NCT04325035 · ClinicalTrials.gov registry record · Phase 2

The Safety and Efficacy of Istaroxime for Pre-Cardiogenic Shock

A Phase 2 study, sponsored by Windtree Therapeutics.

Completed
Registry status
Phase 2
Development phase
90
Enrollment target

NCT04325035: Completed Phase 2 study, sponsored by Windtree Therapeutics.

NCT04325035 is a Phase 2 study that has completed, run by Windtree Therapeutics. The registered enrollment target is 90 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04325035, a Phase 2 study, has completed, sponsored by Windtree Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
90 participants
Enrollment target

Study Summary

This is a pilot, multinational, randomized, double-blind, placebo-controlled, 2-part safety and efficacy study. Subjects will consist of patients hospitalized for acute decompensated heart failure with persistent hypotension.

Primary Outcome

Change from baseline AUC for systolic blood pressure

Interventions

  • DRUG Placebo
  • DRUG Istaroxime

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2020-09-28
Est. Completion 2024-10-30
Phase Phase 2
Windtree Therapeutics

11 total trials

What the finished NCT04325035 record still lists

NCT04325035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04325035 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04325035 about?

NCT04325035 is a clinical study titled "The Safety and Efficacy of Istaroxime for Pre-Cardiogenic Shock". This is a pilot, multinational, randomized, double-blind, placebo-controlled, 2-part safety and efficacy study. Subjects will consist of patients hospitalized for acute decompensated heart failure with persistent hypotension.

What is the current status of trial NCT04325035?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2020-09-28. Estimated completion is 2024-10-30.

What interventions are being tested in trial NCT04325035?

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

Who is sponsoring clinical trial NCT04325035?

This trial is sponsored by Windtree Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04325035's enrollment target sits among peer trials

90 772nd of 2000 higher than 1,199 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04325035, the US trial registry maintained by the National Library of Medicine. NCT04325035 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.