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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 is a Phase 2 study that has completed, run by AbbVie (prior sponsor, Abbott). The registered enrollment target is 48 participants.

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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

Sponsor

AbbVie (prior sponsor, Abbott)

88 total trials

What the Registry Record Tells You About NCT01399580

The ClinicalTrials.gov registry entry for NCT01399580 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie (prior sponsor, Abbott), which has 88 total studies on file at ClinicalTrials.gov.

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

NCT01399580 reports 0 study locations.

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.

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.