HypercholesterolemiaPhase 4NCT00529178
Pravastatin Efficacy and Safety Trial in Hypercholesterolemic Patients With Chronic Liver Disease
A Phase 4 study testing Pravastatin in people with Hypercholesterolemia, run by Bristol-Myers Squibb.
Trial summary
To determine in hypercholesterolemic subjects with chronic, well-compensated liver disease, the percent change from baseline to Week 12 in serum LDL-C of pravastatin 80 mg compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Pravastatin
- How many people
- 232 participants
- Where
- No sites listed yet
- Study dates
- Dec 2002to Mar 2005
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic, well-compensated stable liver
- Hypercholesterolemia
Who cannot join
- Signs or symptoms of ascites, jaundice, or cirrhosis with a Child-Pugh Score > 5
- History of disorders affecting serum bilirubin levels, more than 1 chronic liver disease, significant endocrine, renal, or gastrointestinal disease, or uncontrolled hypertension
- Treatment with lipid-lowering drugs, unless they have been withdrawn within the timeframe specified in the protocol
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Study to Determine the Efficacy and Safety of Pravastatin 80 mg Administered Once Daily to Hypercholesterolemic Subjects With Chronic, Well Compensated Liver Disease
To determine in hypercholesterolemic subjects with chronic, well-compensated liver disease, the percent change from baseline to Week 12 in serum LDL-C of pravastatin 80 mg compared to placebo.
- Conditions
- Hypercholesterolemia
- Being tested
- Pravastatin
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PravastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
serum LDL-C
Measured: at week 12
ALT value
Secondary outcomes (2)
change in HDL-C, TC and TG
Measured: at week 12
clinical symptoms related to acute hepatic injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startDec 2002
- Primary completionMar 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529178
- Sponsor's protocol ID
- CV123-246
- Status last verified
- Apr 2011
- First submitted
- 13 Sep 2007
- Last updated
- 25 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lewis JH, Mortensen ME, Zweig S, Fusco MJ, Medoff JR, Belder R; Pravastatin in Chronic Liver Disease Study Investigators. Efficacy and safety of high-dose pravastatin in hypercholesterolemic patients with well-compensated chronic liver disease: Results of a prospective, randomized, double-blind, placebo-controlled, multicenter trial. Hepatology. 2007 Nov;46(5):1453-63. doi: 10.1002/hep.21848.
PubMed 17668878
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Study to Determine the Efficacy and Safety of Pravastatin 80 mg Administered Once Daily to Hypercholesterolemic Subjects With Chronic, Well Compensated Liver Disease
- ClinicalTrials.gov ID
- NCT00529178
- Acronym / sponsor ID
- CV123-246
- Conditions
- Hypercholesterolemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 14 Sep 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.
To determine in hypercholesterolemic subjects with chronic, well-compensated liver disease, the percent change from baseline to Week 12 in serum LDL-C of pravastatin 80 mg compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic, well-compensated stable liver
- Hypercholesterolemia
Key exclusion criteria (3 listed)
- Signs or symptoms of ascites, jaundice, or cirrhosis with a Child-Pugh Score > 5
- History of disorders affecting serum bilirubin levels, more than 1 chronic liver disease, significant endocrine, renal, or gastrointestinal disease, or uncontrolled hypertension
- Treatment with lipid-lowering drugs, unless they have been withdrawn within the timeframe specified in the protocol
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 |
|---|---|---|
| Pravastatin | Drug | – |
Primary outcome
serum LDL-C
Time frame: at week 12
ALT value
2 secondary outcomes
change in HDL-C, TC and TG
Time frame: at week 12
clinical symptoms related to acute hepatic injury
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 25 Apr 2011.
- Derived from this study: PubMed 17668878Lewis JH, Mortensen ME, Zweig S, Fusco MJ, Medoff JR, Belder R; Pravastatin in Chronic Liver Disease Study Investigators. Efficacy and safety of high-dose pravastatin in hypercholesterolemic patients with well-compensated chronic liver disease: Results of a prospective, randomized, double-blind, placebo-controlled, multicenter trial. Hepatology. 2007 Nov;46(5):1453-63. doi: 10.1002/hep.21848.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pravastatin in people with Hypercholesterolemia, run by Bristol-Myers Squibb.
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 2 inclusion and 3 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 25 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
What does the primary outcome measure?
serum LDL-C (time frame: at week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00529178, which also lists 1 linked publication.
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 25 Apr 2011; AzTrials last refreshed its copy on 7 Nov 2026.