Trial Outcomes & Findings for Efficacy and Safety of Fluvastatin Sodium Extended Release Tablets 80 mg Once Daily in Chinese Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia (NCT NCT01551173)
NCT ID: NCT01551173
Last Updated: 2015-08-13
Results Overview
After the patient has been sitting for at least 5 minutes, a 12 hour fasting blood sample will be withdrawn at baseline and endpoint.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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
436 participants
Primary outcome timeframe
Baseline, week 12
Results posted on
2015-08-13
Participant Flow
Participant milestones
| Measure |
Fluvastatin Sodium Extended Release Tablet
Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
|
Fluvastatin Sodium Immediate Release Capsule
Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
218
|
218
|
|
Overall Study
Full Analysis Set (FAS)
|
210
|
214
|
|
Overall Study
COMPLETED
|
190
|
186
|
|
Overall Study
NOT COMPLETED
|
28
|
32
|
Reasons for withdrawal
| Measure |
Fluvastatin Sodium Extended Release Tablet
Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
|
Fluvastatin Sodium Immediate Release Capsule
Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
16
|
|
Overall Study
Adverse Event
|
7
|
6
|
|
Overall Study
Lost to Follow-up
|
5
|
7
|
|
Overall Study
Other
|
5
|
3
|
Baseline Characteristics
Efficacy and Safety of Fluvastatin Sodium Extended Release Tablets 80 mg Once Daily in Chinese Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
Baseline characteristics by cohort
| Measure |
Fluvastatin Sodium Extended Release Tablet
n=218 Participants
Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
|
Fluvastatin Sodium Immediate Release Capsule
n=218 Participants
Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
|
Total
n=436 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.8 Years
STANDARD_DEVIATION 8.39 • n=99 Participants
|
60.4 Years
STANDARD_DEVIATION 9.30 • n=107 Participants
|
59.6 Years
STANDARD_DEVIATION 8.88 • n=206 Participants
|
|
Sex: Female, Male
Female
|
142 Participants
n=99 Participants
|
154 Participants
n=107 Participants
|
296 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
140 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 12Population: 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
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.
Outcome measures
| Measure |
Fluvastatin Sodium Extended Release Tablet
n=210 Participants
Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
|
Fluvastatin Sodium Immediate Release Capsule
n=214 Participants
Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
|
|---|---|---|
|
Mean Percent Change in LDL-C From Baseline at Study Endpoint, Week 12 (LOCF)
|
-8.692 Percent change
Standard Error 1.4229
|
-7.887 Percent change
Standard Error 1.4258
|
SECONDARY outcome
Timeframe: Baseline, week 4, week 8, week 12, EndpointPopulation: 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
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
Outcome measures
| Measure |
Fluvastatin Sodium Extended Release Tablet
n=210 Participants
Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
|
Fluvastatin Sodium Immediate Release Capsule
n=214 Participants
Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
|
|---|---|---|
|
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)
TG week 8 (n=193,194)
|
-0.065 mmol/L
Standard Error 0.0373
|
-0.134 mmol/L
Standard Error 0.0381
|
|
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)
LDL-C week 4 (n=210,214)
|
-0.447 mmol/L
Standard Error 0.0427
|
-0.438 mmol/L
Standard Error 0.0426
|
|
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)
LDL-C week 8 (n=193,194)
|
-0.418 mmol/L
Standard Error 0.0460
|
-0.408 mmol/L
Standard Error 0.0465
|
|
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)
LDL-C week 12 (n=192,189)
|
-0.353 mmol/L
Standard Error 0.0475
|
-0.377 mmol/L
Standard Error 0.0485
|
|
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)
LDL-C Endpoint (n=210,214)
|
-0.339 mmol/L
Standard Error 0.0483
|
-0.298 mmol/L
Standard Error 0.0484
|
|
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)
TC week 4 (n=205,211)
|
-0.450 mmol/L
Standard Error 0.0497
|
-0.457 mmol/L
Standard Error 0.0495
|
|
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)
TC week week 8 (n=193,194)
|
-0.409 mmol/L
Standard Error 0.0497
|
-0.419 mmol/L
Standard Error 0.0503
|
|
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)
TC week 12 (n=192,189)
|
-0.314 mmol/L
Standard Error 0.0531
|
-0.376 mmol/L
Standard Error 0.0542
|
|
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)
TC Endpoint (n=210,214)
|
-0.294 mmol/L
Standard Error 0.0548
|
-0.290 mmol/L
Standard Error 0.0549
|
|
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)
HDL-C week 4 (n=205,211)
|
-0.004 mmol/L
Standard Error 0.0118
|
0.002 mmol/L
Standard Error 0.0118
|
|
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)
HDL-C week 8 (n=193,194)
|
0.012 mmol/L
Standard Error 0.0128
|
0.016 mmol/L
Standard Error 0.0130
|
|
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)
HDL-C week 12 (n=192,189)
|
0.034 mmol/L
Standard Error 0.0129
|
0.010 mmol/L
Standard Error 0.0132
|
|
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)
HDL-C Endpoint (n=210,214)
|
0.030 mmol/L
Standard Error 0.0123
|
0.012 mmol/L
Standard Error 0.0124
|
|
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)
non HDL-C week 4 (n=205,211)
|
-0.447 mmol/L
Standard Error 0.0488
|
-0.461 mmol/L
Standard Error 0.0487
|
|
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)
non HDL-C week 8 (n=193,194)
|
-0.422 mmol/L
Standard Error 0.0484
|
-0.438 mmol/L
Standard Error 0.0490
|
|
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)
non HDL-C week 12 (192,189)
|
-0.350 mmol/L
Standard Error 0.0528
|
-0.388 mmol/L
Standard Error 0.0540
|
|
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)
non-HDL Endpoint (n=210,214)
|
-0.325 mmol/L
Standard Error 0.0550
|
-0.305 mmol/L
Standard Error 0.0551
|
|
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)
TG week 4(n=205,211)
|
-0.055 mmol/L
Standard Error 0.0550
|
-0.096 mmol/L
Standard Error 0.0554
|
|
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)
TG week 12 (n=192,189)
|
-0.056 mmol/L
Standard Error 0.0498
|
-0.124 mmol/L
Standard Error 0.0514
|
|
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)
TG Endpoint (n=210,214)
|
-0.031 mmol/L
Standard Error 0.0559
|
-0.088 mmol/L
Standard Error 0.0566
|
SECONDARY outcome
Timeframe: Baseline, week 4, week 8, week 12, EndpointPopulation: 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
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.
Outcome measures
| Measure |
Fluvastatin Sodium Extended Release Tablet
n=210 Participants
Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
|
Fluvastatin Sodium Immediate Release Capsule
n=214 Participants
Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
|
|---|---|---|
|
Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint
Moderate cardiovascular risk at week 4
|
50 Percent of participants
|
57.1 Percent of participants
|
|
Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint
Moderate cardiovascular risk at week 8
|
70 Percent of participants
|
58.3 Percent of participants
|
|
Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint
Moderate cardiovascular risk at week 12
|
50 Percent of participants
|
54.5 Percent of participants
|
|
Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint
Moderate cardiovascular risk Endpoint
|
50 Percent of participants
|
42.9 Percent of participants
|
|
Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint
high cardiovascular risk at week 4
|
27.2 Percent of participants
|
25.9 Percent of participants
|
|
Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint
high cardiovascular risk at week 8
|
27.9 Percent of participants
|
29.1 Percent of participants
|
|
Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint
high cardiovascular risk at week 12
|
33 Percent of participants
|
26.4 Percent of participants
|
|
Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint
high cardiovascular risk at Endpoint
|
31.5 Percent of participants
|
24.5 Percent of participants
|
Adverse Events
LescolXL (Fluvastatin Sodium Extended Release Tablet)
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
LescolIR (Fluvastatin Sodium Immediate Release Capsule)
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Total
Serious events: 6 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LescolXL (Fluvastatin Sodium Extended Release Tablet)
n=218 participants at risk
Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
|
LescolIR (Fluvastatin Sodium Immediate Release Capsule)
n=218 participants at risk
Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
|
Total
n=436 participants at risk
|
|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.46%
1/218
|
0.00%
0/218
|
0.23%
1/436
|
|
Gastrointestinal disorders
Rectal polyp
|
0.46%
1/218
|
0.00%
0/218
|
0.23%
1/436
|
|
Injury, poisoning and procedural complications
Drug administration error
|
0.00%
0/218
|
0.46%
1/218
|
0.23%
1/436
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.46%
1/218
|
0.00%
0/218
|
0.23%
1/436
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/218
|
0.46%
1/218
|
0.23%
1/436
|
|
Nervous system disorders
Lacunar infarction
|
0.46%
1/218
|
0.00%
0/218
|
0.23%
1/436
|
|
Surgical and medical procedures
Rectal polypectomy
|
0.46%
1/218
|
0.00%
0/218
|
0.23%
1/436
|
Other adverse events
| Measure |
LescolXL (Fluvastatin Sodium Extended Release Tablet)
n=218 participants at risk
Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
|
LescolIR (Fluvastatin Sodium Immediate Release Capsule)
n=218 participants at risk
Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
|
Total
n=436 participants at risk
|
|---|---|---|---|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.92%
2/218
|
1.4%
3/218
|
1.1%
5/436
|
|
Infections and infestations
Urinary tract infection
|
1.8%
4/218
|
1.4%
3/218
|
1.6%
7/436
|
|
Investigations
Blood creatine phosphokinase increased
|
1.8%
4/218
|
0.92%
2/218
|
1.4%
6/436
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.92%
2/218
|
1.4%
3/218
|
1.1%
5/436
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.4%
3/218
|
1.4%
3/218
|
1.4%
6/436
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
3/218
|
0.00%
0/218
|
0.69%
3/436
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER