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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluvastatin sodium Extended Release Tablet | Experimental | Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks |
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| Fluvastatin sodium Immediate Release Capsule | Active Comparator | Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluvastatin sodium | Drug | Fluvastatin sodium Extended Release Tablets 80mg |
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| Measure | Description | Time Frame |
|---|---|---|
| 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Week 12 (LOCF) | After the patient has been sitting for at least 5 minutes, a 12 hour fasting blood sample will be withdrawn at baseline and endpoint.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. | Baseline, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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Triglycerides (TG) | After the patient has been sitting for at least 5 minutes, a 12 hour fasting blood sample will be withdrawn.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 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Changsha | Hunan | 410011 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluvastatin Sodium Extended Release Tablet | Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks |
| FG001 | Fluvastatin Sodium Immediate Release Capsule | Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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. | Baseline, week 4, week 8, week 12, Endpoint |
| Full Analysis Set (FAS) |
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| COMPLETED |
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| NOT COMPLETED |
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Randomized Set (RAN)
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluvastatin Sodium Extended Release Tablet | Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks |
| BG001 | Fluvastatin Sodium Immediate Release Capsule | Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | FAS: all randomized patients who received at least one dose of double-blind study medication and one post-randomization efficacy parameter measurement. The intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. Endpoint: final available post-baseline assessment to last scheduled visit | Posted | Mean | Standard Error | Percent change | Baseline, week 12 |
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| Secondary | 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 | FAS: all randomized patients who received at least one dose of double-blind study medication and one post-randomization efficacy parameter measurement. The intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. Endpoint: final available post-baseline assessment to last scheduled visit | Posted | Mean | Standard Error | mmol/L | Baseline, week 4, week 8, week 12, Endpoint |
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| Secondary | 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. | FAS: all randomized patients who received at least one dose of double-blind study medication and one post-randomization efficacy parameter measurement. The intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. Endpoint: final available post-baseline assessment to last scheduled visit | Posted | Number | Percent of participants | Baseline, week 4, week 8, week 12, Endpoint |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LescolXL (Fluvastatin Sodium Extended Release Tablet) | Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks | 4 | 218 | 18 | 218 | ||
| EG001 | LescolIR (Fluvastatin Sodium Immediate Release Capsule) | Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks | 2 | 218 | 14 | 218 | ||
| EG002 | Total | 6 | 436 | 32 | 436 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| Rectal polyp | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Drug administration error | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Lacunar infarction | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Rectal polypectomy | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | trialandresults.registries@novartis.com |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077340 | Fluvastatin |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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| Male |
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