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NCT01356849 · ClinicalTrials.gov registry record · Phase 2
Evaluate the Efficacy and Safety of Once Daily Administration of Atrasentan Tablets (Low and High) Compared to Placebo in Reducing Residual Albuminuria in Type 2 Diabetic Patients With Nephropathy Who Are Treated With the Maximum Tolerated Labeled Dose of a Renin Angiotensin System (RAS) Inhibitor
A Phase 2 study, sponsored by AbbVie (prior sponsor, Abbott).
- Completed
- Registry status
- Phase 2
- Development phase
- 149
- Enrollment target
NCT01356849 is a Phase 2 study that has completed, run by AbbVie (prior sponsor, Abbott). The registered enrollment target is 149 participants.
The verdict
NCT01356849, a Phase 2 study, has completed, sponsored by AbbVie (prior sponsor, Abbott).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 149 participants
- Enrollment target
Study Summary
Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Study. The objective of the study is to evaluate the efficacy and safety of once daily administration of atrasentan tablets (low dose and high dose) compared to placebo in reducing residual albuminuria in Type 2 diabetic patients with nephropathy who are treated with the maximum tolerated labeled dose of a Renin Angiotensin System (RAS) inhibitor. If the patient is already receiving a maximum tolerated labeled daily dose of RAS inhibitor and a diuretic, he/she will complete 4 weeks of the Run-in Period on a dose that has not been adjusted. If the patient is currently not receiving a maximum labeled daily dose of a RAS inhibitor then the dose will be titrated up to the maximum tolerated labeled dose over the course of 4 to 8 weeks during the Run-in Period. It is expected that subjects not receiving a diuretic will have a diuretic added or titrated during this period to maximize RAS inhibition. Following titration to the maximum tolerated labeled dose, the patient will complete an additional 4 weeks of Run-In Period on an unchanged doses of RAS inhibitor and diuretics, unless medically contraindicated. The randomization will be stratified based on country where subjects are enrolled into the study, and the Week -1 Urinary Albumin to Creatinine Ratio (UACR) levels (\< or = 1000 mg/g \[113 mg/mmol\], or \> 1000 mg/g \[113 mg/mmol\]). Within each stratum, subjects will be randomly assigned in a 1:2:2 ratio to one of the following blinded treatment groups: Group A - Placebo once daily (QD) Group B - low dose atrasentan QD Group C - high dose atrasentan QD After the 12 weeks of study drug treatment, subjects will be followed up to 30 days.
Interventions
- DRUG Placebo
- DRUG Atrasentan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 149 participants |
| Start Date | 2011-04 |
| Est. Completion | 2012-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01356849
The ClinicalTrials.gov registry entry for NCT01356849 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 149 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.
NCT01356849 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01356849 about?
NCT01356849 is a clinical study titled "Evaluate the Efficacy and Safety of Once Daily Administration of Atrasentan Tablets (Low and High) Compared to Placebo in Reducing Residual Albuminuria in Type 2 Diabetic Patients With Nephropathy Who Are Treated With the Maximum Tolerated Labeled Dose of a Renin Angiotensin System (RAS) Inhibitor". Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Study. The objective of the study is to evaluate the efficacy and safety of once daily administration of atrasentan tablets (low dose and high dose) compared to placebo in reducing residual albuminuria in Type 2 diabetic patients ...
What is the current status of trial NCT01356849?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 149 participants. The study started on 2011-04. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01356849?
The interventions under investigation include: Placebo (DRUG), Atrasentan (DRUG).
Who is sponsoring clinical trial NCT01356849?
This trial is sponsored by AbbVie (prior sponsor, Abbott), which has 88 total clinical trials registered on ClinicalTrials.gov.
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