Lipid Metabolism DisordersPhase 4NCT01551173
Efficacy and Safety of Fluvastatin Sodium Extended Release Tablets 80 mg Once Daily in Chinese Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
A Phase 4 study testing Fluvastatin sodium in people with Lipid Metabolism Disorders, run by Novartis Pharmaceuticals at 1 site in China.
Trial summary
This study is to demonstrate therapeutic comparability of Fluvastatin sodium Extended Release Tablets 80 mg QD and Fluvastatin sodium Immediate Release Capsules 40 mg BID in LDL-C lowering from baseline to week 12 (endpoint) in patients with primary hypercholesterolemia or mixed dyslipidemia at moderate or high CV… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lipid Metabolism Disorders
- What is being tested?
- Fluvastatin sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 436 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to May 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients with primary hypercholesterolemia or mixed dyslipidemia at moderate or high CV risk according to Chinese Dyslipidemia Guideline (2007).
- Not having achieved lipid treatment goals despite following a cholesterol restrictive diet and/or lipid lowering monotherapy improperly prior to Visit 1 (inclusion in the 6-week open-label study phase).
- Not having achieved lipid treatment goals on a stable dose of Fluvastatin sodium Immediate Release Capsule 40 mg QD during the 6 week open-label study phase (inclusion in the 12-week double-blind study phase).
Who cannot join
- Patients with known hypersensitivity to fluvastatin or any of the excipients.
- Dyslipidemia secondary to other causes.
- Known muscle disease or history of muscle disease and/or serum CPK levels greater than 2 x upper limit of normal (ULN).
- A history or evidence of Acute Myocardial infarction (AMI), unstable angina (UA) or Coronary artery bypass surgery or Percutaneous Coronary Intervention (PCI) within the previous 8 weeks.
- Active liver disease and/or serum transaminase levels (ALT, AST) greater than 1.5 x ULN.
- Patients on a proper lipid lowering monotherapy (defined as at least 12 weeks continuous monotherapy with a recommended dose and administration in the label) within the previous 3 months prior to visit 1.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 12-week, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group Study to Assess the Efficacy and Safety of Fluvastatin Sodium Extended Release Tablets 80 mg Once Daily Compared to Fluvastatin Sodium Immediate Release Capsules 40 mg Twice Daily (BID) in Chinese Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia at Moderate or High Cardiovascular Risk Who Did Not Achieve Their Lipid Goals When Treated With Fluvastatin Sodium Immediate Release Capsules 40 mg QD
This study is to demonstrate therapeutic comparability of Fluvastatin sodium Extended Release Tablets 80 mg QD and Fluvastatin sodium Immediate Release Capsules 40 mg BID in LDL-C lowering from baseline to week 12 (endpoint) in patients with primary hypercholesterolemia or mixed dyslipidemia at moderate or high CV risk who did not achieve their lipid goals when treated with Fluvastatin sodium Immediate Release Capsules 40 mg QD.
- Conditions
- Lipid Metabolism Disorders
- Being tested
- Fluvastatin sodium
- Keywords
- Dyslipidemias, Fluvastatin sodium, Chinese
- Medical subject headings
- Lipid Metabolism Disorders, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluvastatin sodiumDrug
Fluvastatin sodium Extended Release Tablets 80mg
| Study group | Role | What they receive |
|---|---|---|
| Fluvastatin sodium Extended Release Tablet | Experimental | Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks Receives: Drug: Fluvastatin sodium |
| Fluvastatin sodium Immediate Release Capsule | Active comparator | Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks Receives: Drug: Fluvastatin sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Change in LDL-C From Baseline at Study Endpoint, Week 12 (LOCF)
After the patient has been sitting for at least 5 minutes, a 12 hour fasting blood sample will be withdrawn at baseline and endpoint. An analysis of covariance (ANCOVA) with treatment, center, and indication category as factors and baseline LDL-C as a covariate will be used to analyze percent change from baseline in LDL-C.
Measured: Baseline, week 12
Secondary outcomes (2)
Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG)
After the patient has been sitting for at least 5 minutes, a 12 hour fasting blood sample will be withdrawn. An analogous ANCOVA model to that used in the analysis of the primary variable will be used to compare the change in LDL-C, TC, HDL-C, non HDL-C and TG from baseline between treatment groups at Week 4, Week 8, and Week 12
Measured: Baseline, week 4, week 8, week 12, Endpoint
Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint
LDL-C treatment goal is defined as patients at moderate CV risk with LDL-C levels < 3.37 mmol/L (130 mg/dL) or patients at high CV-risk with LDL-C levels < 2.59 mmol/L (100 mg/dL). The proportion of patients in each treatment group achieving their LDL-C goal during the double-blind period will be compared at Week 4, Week 8, Week 12 and Endpoint using a logistic regression model with treatment and center as factors and baseline LDL-C as a covariate. Odds ratio estimates derived from the logistic regression model and 95%CI will be used to quantify the treatment effect.
Measured: Baseline, week 4, week 8, week 12, Endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lipid Metabolism DisordersStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Who is masked
- Participant, Investigator
- Enrolment
- 436 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551173
- Sponsor's protocol ID
- CXUO320BCN01
- Status last verified
- Aug 2015
- First submitted
- 8 Mar 2012
- Last updated
- 13 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group Study to Assess the Efficacy and Safety of Fluvastatin Sodium Extended Release Tablets 80 mg Once Daily Compared to Fluvastatin Sodium Immediate Release Capsules 40 mg Twice Daily (BID) in Chinese Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia at Moderate or High Cardiovascular Risk Who Did Not Achieve Their Lipid Goals When Treated With Fluvastatin Sodium Immediate Release Capsules 40 mg QD
- ClinicalTrials.gov ID
- NCT01551173
- Acronym / sponsor ID
- CXUO320BCN01
- Conditions
- Lipid Metabolism Disorders
- Keywords
- Dyslipidemias, Fluvastatin sodium, Chinese
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 436 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 12 Mar 2012 (estimated)
- Results
- Posted 11 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to demonstrate therapeutic comparability of Fluvastatin sodium Extended Release Tablets 80 mg QD and Fluvastatin sodium Immediate Release Capsules 40 mg BID in LDL-C lowering from baseline to week 12 (endpoint) in patients with primary hypercholesterolemia or mixed dyslipidemia at moderate or high CV risk who did not achieve their lipid goals when treated with Fluvastatin sodium Immediate Release Capsules 40 mg QD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluvastatin sodium Extended Release Tablet | Experimental | Drug: Fluvastatin sodiumOral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks |
| Fluvastatin sodium Immediate Release Capsule | Active comparator | Drug: Fluvastatin sodiumOral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with primary hypercholesterolemia or mixed dyslipidemia at moderate or high CV risk according to Chinese Dyslipidemia Guideline (2007).
- Not having achieved lipid treatment goals despite following a cholesterol restrictive diet and/or lipid lowering monotherapy improperly prior to Visit 1 (inclusion in the 6-week open-label study phase).
- Not having achieved lipid treatment goals on a stable dose of Fluvastatin sodium Immediate Release Capsule 40 mg QD during the 6 week open-label study phase (inclusion in the 12-week double-blind study phase).
Key exclusion criteria (7 listed)
- Patients with known hypersensitivity to fluvastatin or any of the excipients.
- Dyslipidemia secondary to other causes.
- Known muscle disease or history of muscle disease and/or serum CPK levels greater than 2 x upper limit of normal (ULN).
- A history or evidence of Acute Myocardial infarction (AMI), unstable angina (UA) or Coronary artery bypass surgery or Percutaneous Coronary Intervention (PCI) within the previous 8 weeks.
- Active liver disease and/or serum transaminase levels (ALT, AST) greater than 1.5 x ULN.
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 |
|---|---|---|
| Fluvastatin sodiumFluvastatin sodium Extended Release Tablets 80mg | Drug | Fluvastatin sodium Extended Release Tablet, Fluvastatin sodium Immediate Release Capsule |
Primary outcome
Mean Percent Change in LDL-C From Baseline at Study Endpoint, Week 12 (LOCF)
Time frame: Baseline, week 12
After the patient has been sitting for at least 5 minutes, a 12 hour fasting blood sample will be withdrawn at baseline and endpoint. An analysis of covariance (ANCOVA) with treatment, center, and indication category as factors and baseline LDL-C as a covariate will be used to analyze percent change from baseline in LDL-C.
2 secondary outcomes
Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG)
Time frame: Baseline, week 4, week 8, week 12, Endpoint
Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint
Time frame: Baseline, week 4, week 8, week 12, Endpoint
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluvastatin sodium in people with Lipid Metabolism Disorders, run by Novartis Pharmaceuticals at 1 site in China.
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 3 inclusion and 7 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 13 Aug 2015. 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 China. 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 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?
Yes. Results are posted in the registry (first posted 11 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Percent Change in LDL-C From Baseline at Study Endpoint, Week 12 (LOCF) (time frame: Baseline, week 12). 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 13 Aug 2015.