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NCT01807221 · ClinicalTrials.gov registry record · Phase 2

Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone

A Phase 2 study, sponsored by Bayer.

Completed
Registry status
Phase 2
Development phase
1,066
Enrollment target

NCT01807221: Completed Phase 2 study, sponsored by Bayer.

NCT01807221 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 1,066 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (702% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01807221, a Phase 2 study, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 2
Development phase
1,066 participants
Enrollment target

Study Summary

To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses were compared to eplerenone, another marketed drug approved to treat heart failure.

Primary Outcome

N-terminal pro-B type natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute and chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.

Interventions

  • DRUG Placebo
  • DRUG Finerenone (BAY94-8862)
  • DRUG Inspra (eplerenone)

Trial Details

FieldValue
Enrollment Target 1,066 participants
Start Date 2013-06-17
Est. Completion 2014-12-09
Phase Phase 2
Bayer

591 total trials

What the finished NCT01807221 record still lists

NCT01807221 is an interventional study that assigns participants to a tested intervention. Its 1,066 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (702% higher).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT01807221 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01807221 about?

NCT01807221 is a clinical study titled "Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone". To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses were compa...

What is the current status of trial NCT01807221?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,066 participants. The study started on 2013-06-17. Estimated completion is 2014-12-09.

What interventions are being tested in trial NCT01807221?

The interventions under investigation include: Placebo (DRUG), Finerenone (BAY94-8862) (DRUG), Inspra (eplerenone) (DRUG).

Who is sponsoring clinical trial NCT01807221?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01807221's enrollment target sits among peer trials

1,066 24th of 2000 higher than 1,977 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 NCT01807221, the US trial registry maintained by the National Library of Medicine. NCT01807221 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.