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NCT01399580 · ClinicalTrials.gov registry record · Phase 2

A Prospective, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy and Safety of Atrasentan, Including Thoracic Bioimpedance, in Type 2 Diabetic Subjects With Nephropathy

A Phase 2 study, sponsored by AbbVie (prior sponsor, Abbott).

Completed
Registry status
Phase 2
Development phase
48
Enrollment target

NCT01399580: Completed Phase 2 study, sponsored by AbbVie (prior sponsor, Abbott).

NCT01399580 is a Phase 2 study that has completed, run by AbbVie (prior sponsor, Abbott). The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01399580, a Phase 2 study, has completed, sponsored by AbbVie (prior sponsor, Abbott).

COMPLETED
Registry status
Phase 2
Development phase
48 participants
Enrollment target

Study Summary

Prospective, Randomized, Double-Blind, Parallel Design, Placebo-Controlled Multicenter Study. The study objectives are to evaluate efficacy and safety, including thoracic bioimpedance, of once daily administration of atrasentan tablets (high dose and low dose) compared to placebo in type 2 diabetic subjects with nephropathy who are receiving the maximum tolerated labeled daily dose of a RAS inhibitor.

Interventions

  • DRUG Placebo
  • DRUG Atrasentan

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2011-08
Est. Completion 2012-09
Phase Phase 2
AbbVie (prior sponsor, Abbott)

88 total trials

What the finished NCT01399580 record still lists

NCT01399580 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).

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

NCT01399580 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01399580 about?

NCT01399580 is a clinical study titled "A Prospective, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy and Safety of Atrasentan, Including Thoracic Bioimpedance, in Type 2 Diabetic Subjects With Nephropathy". Prospective, Randomized, Double-Blind, Parallel Design, Placebo-Controlled Multicenter Study. The study objectives are to evaluate efficacy and safety, including thoracic bioimpedance, of once daily administration of atrasentan tablets (high dose and low dose) compared to placebo in type 2 diabetic ...

What is the current status of trial NCT01399580?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2011-08. Estimated completion is 2012-09.

What interventions are being tested in trial NCT01399580?

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

Who is sponsoring clinical trial NCT01399580?

This trial is sponsored by AbbVie (prior sponsor, Abbott), which has 88 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01399580's enrollment target sits among peer trials

48 1265th of 2000 higher than 718 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 NCT01399580, the US trial registry maintained by the National Library of Medicine. NCT01399580 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.