Hepatitis CPhase 2NCT00446940
Dose Finding Trial of Rosuvastatin and Atorvastatin Versus Hepatitis C
A Phase 2 study testing rosuvastatin and atorvastatin in people with Hepatitis C, run by Bader, Ted, M.D. at 1 site in United States.
Trial summary
Different Doses of rosuvastatin and atorvastatin will be used to see if HCV viral load changes and liver tests change. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- rosuvastatin and atorvastatin
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Mar 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hepatitis C
Who cannot join
- HIV positivity
Trial locations and contacts
1 site in 1 country.
About this study
Different Doses of rosuvastatin and atorvastatin will be used to see if HCV viral load changes and liver tests change.
- Conditions
- Hepatitis C
- Being tested
- rosuvastatin, atorvastatin
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosuvastatinDrug
atorvastatinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2007 (estimated)
- Study startDec 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bader, Ted, M.D.
- Investigators
- Ted Bader, MD, Principal investigator, VA Medical Center, Oklahoma City, OK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446940
- Sponsor's protocol ID
- 13133
- Status last verified
- Sep 2008
- First submitted
- 11 Mar 2007
- Last updated
- 9 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Finding Trial of Rosuvastatin and Atorvastatin Versus Hepatitis C
- ClinicalTrials.gov ID
- NCT00446940
- Acronym / sponsor ID
- 13133
- Conditions
- Hepatitis C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Bader, Ted, M.D.
- Study start
- Dec 2006
- Study completion
- Mar 2007 (actual)
- First posted
- 13 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Different Doses of rosuvastatin and atorvastatin will be used to see if HCV viral load changes and liver tests change.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hepatitis C
Key exclusion criteria (1 listed)
- HIV positivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rosuvastatin | Drug | – |
| atorvastatin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ted Bader, MD principal investigator
VA Medical Center, Oklahoma City, OK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rosuvastatin and atorvastatin in people with Hepatitis C, run by Bader, Ted, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2008.