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NCT00063622 · ClinicalTrials.gov registry record · Phase 3

Pioglitazone vs Vitamin E vs Placebo for Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS)

A Phase 3 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Completed
Registry status
Phase 3
Development phase
247
Enrollment target

NCT00063622 is a Phase 3 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 247 participants.

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The verdict

NCT00063622, a Phase 3 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

COMPLETED
Registry status
Phase 3
Development phase
247 participants
Enrollment target

Study Summary

The purpose of this study is to determine if therapy with pioglitazone or vitamin E will lead to an improvement in liver histology in non-diabetic adult patients with non-alcoholic steatohepatitis (NASH).

Interventions

  • DRUG Matching placebo
  • DRUG Pioglitazone
  • DIETARY_SUPPLEMENT Vitamin E

Trial Details

FieldValue
Enrollment Target 247 participants
Start Date 2005-01
Est. Completion 2009-09
Phase Phase 3

What the Registry Record Tells You About NCT00063622

The ClinicalTrials.gov registry entry for NCT00063622 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 247 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.

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

NCT00063622 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00063622 about?

NCT00063622 is a clinical study titled "Pioglitazone vs Vitamin E vs Placebo for Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS)". The purpose of this study is to determine if therapy with pioglitazone or vitamin E will lead to an improvement in liver histology in non-diabetic adult patients with non-alcoholic steatohepatitis (NASH).

What is the current status of trial NCT00063622?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 247 participants. The study started on 2005-01. Estimated completion is 2009-09.

What interventions are being tested in trial NCT00063622?

The interventions under investigation include: Matching placebo (DRUG), Pioglitazone (DRUG), Vitamin E (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT00063622?

This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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