Fredrickson Type IIa & Type IIb DyslipidaemiaPhase 3NCT00654446
IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin
A Phase 3 study testing Rosuvastatin and Simvastatin in people with Fredrickson Type IIa & Type IIb Dyslipidaemia, run by AstraZeneca.
Trial summary
The purpose of this study is to assess the effects on the kidney of rosuvastatin and simvastatin in subjects with Fredrickson Type IIa \& Type IIb Dyslipidaemia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fredrickson Type IIa & Type IIb Dyslipidaemia
- What is being tested?
- Rosuvastatin and Simvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- No sites listed yet
- Study dates
- Sep 2002to Apr 2004
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fasting low density lipoprotein level as defined by the protocol.
- Fasting triglyceride level as defined by the protocol.
Who cannot join
- The use of lipid lowering drugs or dietary supplements after Visit 1.
- Active arterial disease eg Unstable angina, or recent arterial surgery
- Blood creatine levels above the limits defined in the protocol or +4 proteinuria during dietary lead in period.
- Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.
About this study
Official title: A 6-wk Open-Label, Randomised, Multicentre, Phase IIIb, Parallel-Group Study, Which Describes the Renal Effects of the Lipid-Regulating Agents Rosuvastatin and Simvastatin in the Treatment of Sub's With Fredrickson Type IIa & Type IIb Dyslipidaemia, Inc. Heterozygous Familial Hypercholesterolaemia
The purpose of this study is to assess the effects on the kidney of rosuvastatin and simvastatin in subjects with Fredrickson Type IIa \& Type IIb Dyslipidaemia
- Being tested
- Rosuvastatin, Simvastatin
- Keywords
- Cholesterol, low density lipoproteins, dyslipidaemia, Rosuvastatin, Crestor, Simvastatin, Zocor, Renal, kidney
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
SimvastatinDrug
Also called Zocor
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Rosuvastatin Receives: Drug: Rosuvastatin |
| 2 | Active comparator | Simvastatin Receives: Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Proteinuria
Measured: 2 weekly
Secondary outcomes (3)
Renal effects of rosuvastatin and simvastatin
Measured: 2 weekly
Low density lipoproteins cholesterol levels
Measured: 2 weekly
Safety: adverse events & abnormal laboratory markers
Measured: 2 weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2008 (estimated)
- Study startSep 2002
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fredrickson Type IIa & Type IIb DyslipidaemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 442 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Evan Stein, Principal investigator, Metabolic & Athersclerotic research centre, Cincinatti, USARussell Esterline, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00654446
- Sponsor's protocol ID
- 4522IL/0099
- Status last verified
- Mar 2009
- First submitted
- 3 Apr 2008
- Last updated
- 16 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-wk Open-Label, Randomised, Multicentre, Phase IIIb, Parallel-Group Study, Which Describes the Renal Effects of the Lipid-Regulating Agents Rosuvastatin and Simvastatin in the Treatment of Sub's With Fredrickson Type IIa & Type IIb Dyslipidaemia, Inc. Heterozygous Familial Hypercholesterolaemia
- ClinicalTrials.gov ID
- NCT00654446
- Acronym / sponsor ID
- 4522IL/0099
- Keywords
- Cholesterol, low density lipoproteins, dyslipidaemia, Rosuvastatin, Crestor, Simvastatin, Zocor, Renal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Study completion
- Apr 2004 (actual)
- First posted
- 8 Apr 2008 (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.
The purpose of this study is to assess the effects on the kidney of rosuvastatin and simvastatin in subjects with Fredrickson Type IIa \& Type IIb Dyslipidaemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RosuvastatinRosuvastatin |
| 2 | Active comparator | Drug: SimvastatinSimvastatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fasting low density lipoprotein level as defined by the protocol.
- Fasting triglyceride level as defined by the protocol.
Key exclusion criteria (4 listed)
- The use of lipid lowering drugs or dietary supplements after Visit 1.
- Active arterial disease eg Unstable angina, or recent arterial surgery
- Blood creatine levels above the limits defined in the protocol or +4 proteinuria during dietary lead in period.
- Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.
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 |
|---|---|---|
| RosuvastatinAlso: Crestor | Drug | 1 |
| SimvastatinAlso: Zocor | Drug | 2 |
Primary outcome
Development of Proteinuria
Time frame: 2 weekly
3 secondary outcomes
Renal effects of rosuvastatin and simvastatin
Time frame: 2 weekly
Low density lipoproteins cholesterol levels
Time frame: 2 weekly
Safety: adverse events & abnormal laboratory markers
Time frame: 2 weekly
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 16 Mar 2009.
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.
Evan Stein principal investigator
Metabolic & Athersclerotic research centre, Cincinatti, USA
Russell Esterline study director
AstraZeneca
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rosuvastatin and Simvastatin in people with Fredrickson Type IIa & Type IIb Dyslipidaemia, run by AstraZeneca.
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 4 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 16 Mar 2009. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Development of Proteinuria (time frame: 2 weekly). It is what the study was designed to measure, not a finding.
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 16 Mar 2009.