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NCT01910389 · ClinicalTrials.gov registry record · Phase 3

Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure

A Phase 3 study, sponsored by Carelon Research.

Terminated
Registry status
Phase 3
Development phase
23
Enrollment target

NCT01910389: Clinical Trial Phase 3 study, sponsored by Carelon Research.

NCT01910389 is a Phase 3 study that was terminated before completion, run by Carelon Research. The registered enrollment target is 23 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01910389, a Phase 3 study, was terminated before completion, sponsored by Carelon Research.

TERMINATED
Registry status
Phase 3
Development phase
23 participants
Enrollment target

Study Summary

This study is a multi-center, prospective, randomized, double blind, placebo-controlled clinical trial. Subjects in the study will be adults with New York Heart Association (NYHA) Class II-IV heart failure (HF) due to left ventricular systolic dysfunction (LVSD), left ventricular ejection fraction (LVEF) \<0.40, and secondary pulmonary hypertension (PH). The purpose of the study is to evaluate the safety, effectiveness, and effects of tadalafil compared to placebo on the subjects' functional capacity / quality of life.

Interventions

  • DRUG Tadalafil
  • DRUG Placebo for tadalafil

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2013-11
Est. Completion 2014-02
Phase Phase 3
Carelon Research

50 total trials

Why NCT01910389 stopped before completion

NCT01910389 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).

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

NCT01910389 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01910389 about?

NCT01910389 is a clinical study titled "Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure". This study is a multi-center, prospective, randomized, double blind, placebo-controlled clinical trial. Subjects in the study will be adults with New York Heart Association (NYHA) Class II-IV heart failure (HF) due to left ventricular systolic dysfunction (LVSD), left ventricular ejection fraction (...

What is the current status of trial NCT01910389?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 23 participants. The study started on 2013-11. Estimated completion is 2014-02.

What interventions are being tested in trial NCT01910389?

The interventions under investigation include: Tadalafil (DRUG), Placebo for tadalafil (DRUG).

Who is sponsoring clinical trial NCT01910389?

This trial is sponsored by Carelon Research, which has 50 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01910389's enrollment target sits among peer trials

23 1952nd of 2000 higher than 48 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT01910389, the US trial registry maintained by the National Library of Medicine. NCT01910389 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.