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Efficacy and Safety of Fluvastatin Sodium Extended Release Tablets 80 mg Once Daily in Chinese Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

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ClinicalTrials.gov Identifier: NCT01551173
Recruitment Status : Completed
First Posted : March 12, 2012
Results First Posted : June 11, 2014
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Lipid Metabolism Disorders
Intervention Drug: Fluvastatin sodium
Enrollment 436
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fluvastatin Sodium Extended Release Tablet Fluvastatin Sodium Immediate Release Capsule
Hide Arm/Group Description Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
Period Title: Overall Study
Started 218 [1] 218
Full Analysis Set (FAS) 210 [2] 214
Completed 190 186
Not Completed 28 32
Reason Not Completed
Withdrawal by Subject             11             16
Adverse Event             7             6
Lost to Follow-up             5             7
Not specified             5             3
[1]
"Started" indicates randomized
[2]
Patients took at least 1 dose of study drug & had at least 1 post-randomization efficacy parameter
Arm/Group Title Fluvastatin Sodium Extended Release Tablet Fluvastatin Sodium Immediate Release Capsule Total
Hide Arm/Group Description Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 218 218 436
Hide Baseline Analysis Population Description
Randomized Set (RAN)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 218 participants 218 participants 436 participants
58.8  (8.39) 60.4  (9.30) 59.6  (8.88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 218 participants 218 participants 436 participants
Female
142
  65.1%
154
  70.6%
296
  67.9%
Male
76
  34.9%
64
  29.4%
140
  32.1%
1.Primary Outcome
Title Mean Percent Change in LDL-C From Baseline at Study Endpoint, Week 12 (LOCF)
Hide Description 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.
Time Frame Baseline, week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Fluvastatin Sodium Extended Release Tablet Fluvastatin Sodium Immediate Release Capsule
Hide Arm/Group Description:
Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
Overall Number of Participants Analyzed 210 214
Mean (Standard Error)
Unit of Measure: Percent change
-8.692  (1.4229) -7.887  (1.4258)
2.Secondary Outcome
Title 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)
Hide Description 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
Time Frame Baseline, week 4, week 8, week 12, Endpoint
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Fluvastatin Sodium Extended Release Tablet Fluvastatin Sodium Immediate Release Capsule
Hide Arm/Group Description:
Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
Overall Number of Participants Analyzed 210 214
Mean (Standard Error)
Unit of Measure: mmol/L
LDL-C week 4 (n=210,214) -0.447  (0.0427) -0.438  (0.0426)
LDL-C week 8 (n=193,194) -0.418  (0.0460) -0.408  (0.0465)
LDL-C week 12 (n=192,189) -0.353  (0.0475) -0.377  (0.0485)
LDL-C Endpoint (n=210,214) -0.339  (0.0483) -0.298  (0.0484)
TC week 4 (n=205,211) -0.450  (0.0497) -0.457  (0.0495)
TC week week 8 (n=193,194) -0.409  (0.0497) -0.419  (0.0503)
TC week 12 (n=192,189) -0.314  (0.0531) -0.376  (0.0542)
TC Endpoint (n=210,214) -0.294  (0.0548) -0.290  (0.0549)
HDL-C week 4 (n=205,211) -0.004  (0.0118) 0.002  (0.0118)
HDL-C week 8 (n=193,194) 0.012  (0.0128) 0.016  (0.0130)
HDL-C week 12 (n=192,189) 0.034  (0.0129) 0.010  (0.0132)
HDL-C Endpoint (n=210,214) 0.030  (0.0123) 0.012  (0.0124)
non HDL-C week 4 (n=205,211) -0.447  (0.0488) -0.461  (0.0487)
non HDL-C week 8 (n=193,194) -0.422  (0.0484) -0.438  (0.0490)
non HDL-C week 12 (192,189) -0.350  (0.0528) -0.388  (0.0540)
non-HDL Endpoint (n=210,214) -0.325  (0.0550) -0.305  (0.0551)
TG week 4(n=205,211) -0.055  (0.0550) -0.096  (0.0554)
TG week 8 (n=193,194) -0.065  (0.0373) -0.134  (0.0381)
TG week 12 (n=192,189) -0.056  (0.0498) -0.124  (0.0514)
TG Endpoint (n=210,214) -0.031  (0.0559) -0.088  (0.0566)
3.Secondary Outcome
Title Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint
Hide Description 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.
Time Frame Baseline, week 4, week 8, week 12, Endpoint
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Fluvastatin Sodium Extended Release Tablet Fluvastatin Sodium Immediate Release Capsule
Hide Arm/Group Description:
Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
Overall Number of Participants Analyzed 210 214
Measure Type: Number
Unit of Measure: Percent of participants
Moderate cardiovascular risk at week 4 50 57.1
Moderate cardiovascular risk at week 8 70 58.3
Moderate cardiovascular risk at week 12 50 54.5
Moderate cardiovascular risk Endpoint 50 42.9
high cardiovascular risk at week 4 27.2 25.9
high cardiovascular risk at week 8 27.9 29.1
high cardiovascular risk at week 12 33 26.4
high cardiovascular risk at Endpoint 31.5 24.5
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LescolXL (Fluvastatin Sodium Extended Release Tablet) LescolIR (Fluvastatin Sodium Immediate Release Capsule) Total
Hide Arm/Group Description Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks Total of all reporting groups
All-Cause Mortality
LescolXL (Fluvastatin Sodium Extended Release Tablet) LescolIR (Fluvastatin Sodium Immediate Release Capsule) Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
LescolXL (Fluvastatin Sodium Extended Release Tablet) LescolIR (Fluvastatin Sodium Immediate Release Capsule) Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/218 (1.83%)   2/218 (0.92%)   6/436 (1.38%) 
Cardiac disorders       
Coronary artery disease  1  1/218 (0.46%)  0/218 (0.00%)  1/436 (0.23%) 
Gastrointestinal disorders       
Rectal polyp  1  1/218 (0.46%)  0/218 (0.00%)  1/436 (0.23%) 
Injury, poisoning and procedural complications       
Drug administration error  1  0/218 (0.00%)  1/218 (0.46%)  1/436 (0.23%) 
Nervous system disorders       
Cerebral haemorrhage  1  1/218 (0.46%)  0/218 (0.00%)  1/436 (0.23%) 
Cerebral infarction  1  0/218 (0.00%)  1/218 (0.46%)  1/436 (0.23%) 
Lacunar infarction  1  1/218 (0.46%)  0/218 (0.00%)  1/436 (0.23%) 
Surgical and medical procedures       
Rectal polypectomy  1  1/218 (0.46%)  0/218 (0.00%)  1/436 (0.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
LescolXL (Fluvastatin Sodium Extended Release Tablet) LescolIR (Fluvastatin Sodium Immediate Release Capsule) Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   18/218 (8.26%)   14/218 (6.42%)   32/436 (7.34%) 
Hepatobiliary disorders       
Hepatic function abnormal  1  2/218 (0.92%)  3/218 (1.38%)  5/436 (1.15%) 
Infections and infestations       
Urinary tract infection  1  4/218 (1.83%)  3/218 (1.38%)  7/436 (1.61%) 
Investigations       
Blood creatine phosphokinase increased  1  4/218 (1.83%)  2/218 (0.92%)  6/436 (1.38%) 
Gamma-glutamyltransferase increased  1  2/218 (0.92%)  3/218 (1.38%)  5/436 (1.15%) 
Metabolism and nutrition disorders       
Hyperuricaemia  1  3/218 (1.38%)  3/218 (1.38%)  6/436 (1.38%) 
Skin and subcutaneous tissue disorders       
Rash  1  3/218 (1.38%)  0/218 (0.00%)  3/436 (0.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01551173     History of Changes
Other Study ID Numbers: CXUO320BCN01
First Submitted: March 8, 2012
First Posted: March 12, 2012
Results First Submitted: May 13, 2014
Results First Posted: June 11, 2014
Last Update Posted: August 13, 2015