Trials / Completed
CompletedNCT00063622
Pioglitazone vs Vitamin E vs Placebo for Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS)
Clinical Research Network in Nonalcoholic Steatohepatitis: Pioglitazone vs. Vitamin E vs. Placebo for the Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 247 (actual)
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pioglitazone | 30 mg daily |
| DIETARY_SUPPLEMENT | Vitamin E | 800 IU daily |
| DRUG | Matching placebo | Daily |
Timeline
- Start date
- 2005-01-01
- Primary completion
- 2009-06-01
- Completion
- 2009-09-01
- First posted
- 2003-07-03
- Last updated
- 2018-04-06
- Results posted
- 2012-08-01
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00063622. Inclusion in this directory is not an endorsement.