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Rosiglitazone Versus Rosiglitazone and Metformin Versus Rosiglitazone and Avandia in the Treatment of Nonalcoholic Steatohepatitis (NASH)

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ClinicalTrials.gov Identifier: NCT00699036
Recruitment Status : Unknown
Verified June 2009 by Brooke Army Medical Center.
Recruitment status was:  Recruiting
First Posted : June 17, 2008
Last Update Posted : June 19, 2009
Sponsor:
Information provided by:
Brooke Army Medical Center

Tracking Information
First Submitted Date  ICMJE June 16, 2008
First Posted Date  ICMJE June 17, 2008
Last Update Posted Date June 19, 2009
Study Start Date  ICMJE April 2007
Estimated Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2008)
liver biopsy histologic improvement [ Time Frame: end of study ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00699036 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2008)
serum transaminases [ Time Frame: throughout study (ongoing) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Rosiglitazone Versus Rosiglitazone and Metformin Versus Rosiglitazone and Avandia in the Treatment of Nonalcoholic Steatohepatitis (NASH)
Official Title  ICMJE Rosiglitazone Versus Rosiglitazone and Metformin (Avandamet) Versus Combination Rosiglitazone and Losartan in the Treatment of Nonalcoholic Steatohepatitis (NASH). A Prospective, Open-Label, Randomized Trial
Brief Summary The purpose of this study is to evaluate the efficacy of rosiglitazone alone compared with rosiglitazone plus metformin or rosiglitazone plus losartan in the treatment of biopsy proven nonalcoholic steatohepatitis (NASH). This study was designed to answer the question: are there differences in the efficacy (as measured by histopathology and insulin resistance) of three different therapeutic modalities used to treat NASH?
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Nonalcoholic Steatohepatitis
  • Nonalcoholic Fatty Liver Disease
Intervention  ICMJE
  • Drug: avandia
    4 mg twice daily
  • Drug: metformin
    500 mg twice daily for 48 weeks
  • Drug: losartan
    losartan 50 mg once daily
Study Arms
  • Experimental: 1
    avandia
    Intervention: Drug: avandia
  • Experimental: 2
    avandia plus metformin
    Interventions:
    • Drug: avandia
    • Drug: metformin
  • Experimental: 3
    avandia plus losartan
    Interventions:
    • Drug: avandia
    • Drug: losartan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 16, 2008)
165
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date August 2009
Estimated Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients between 18-70 years old
  2. Negative urine pregnancy test in females
  3. History of elevated liver associated enzymes (ALT > 40)
  4. Liver biopsy within 1 year of screening in this study that shows histopathologic findings consistent with NASH

Exclusion Criteria:

  1. ALT greater than three times normal
  2. NYHA class 3 or 4 heart failure
  3. Any congestive heart failure patient on insulin
  4. Patients on one of the 3 study drugs within the past 3 months prior to enrollment
  5. Alcohol consumption >20 gm/day in a female and > 30 gm/day in a male
  6. Evidence of co-existent chronic liver disease to include viral hepatitis, Wilson's disease, autoimmune hepatitis, hemochromatosis, primary biliary cirrhosis, or primary sclerosing cholangitis
  7. Serum creatinine on initial screening of greater than 1.4
  8. Known hypersensitivity to rosiglitazone, metformin, or losartan
  9. Known history of diabetic ketoacidosis
  10. Female that is breastfeeding
  11. Insulin dependent diabetic
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00699036
Other Study ID Numbers  ICMJE C.2007.066
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dawn M. Torres, MD. Principal Investigator, Brooke Army Medical Center
Study Sponsor  ICMJE Brooke Army Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dawn M Torres, MD Brooke Army Medical Center
PRS Account Brooke Army Medical Center
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP