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Dose Finding Trial of Rosuvastatin and Atorvastatin Versus Hepatitis C

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
rosuvastatin
atorvastatin
Sponsored by
Bader, Ted, M.D.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hepatitis C

Exclusion Criteria:

  • HIV positivity

Sites / Locations

  • VA Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 11, 2007
Last Updated
September 8, 2008
Sponsor
Bader, Ted, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT00446940
Brief Title
Dose Finding Trial of Rosuvastatin and Atorvastatin Versus Hepatitis C
Official Title
Dose Finding Trial of Rosuvastatin and Atorvastatin Versus Hepatitis C
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bader, Ted, M.D.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Different Doses of rosuvastatin and atorvastatin will be used to see if HCV viral load changes and liver tests change.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
rosuvastatin
Intervention Type
Drug
Intervention Name(s)
atorvastatin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hepatitis C Exclusion Criteria: HIV positivity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ted Bader, MD
Organizational Affiliation
VA Medical Center, Oklahoma City, OK
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Hospital
City
OKlahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

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Dose Finding Trial of Rosuvastatin and Atorvastatin Versus Hepatitis C

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