NCT01551173

Brief 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 risk who did not achieve their lipid goals when treated with Fluvastatin sodium Immediate Release Capsules 40 mg QD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
436

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 11, 2014

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

1.3 years

First QC Date

March 8, 2012

Results QC Date

May 13, 2014

Last Update Submit

August 10, 2015

Conditions

Lipid Metabolism Disorders

Keywords

DyslipidemiasFluvastatin sodiumChinese

Outcome Measures

Primary Outcomes (1)

  • 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    After the patient has been sitting for at least 5 minutes, a 12 hour fasting blood sample will be withdrawn at baseline and endpoint.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

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)

    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

    Baseline, week 4, week 8, week 12, Endpoint

Study Arms (2)

Fluvastatin sodium Extended Release Tablet

EXPERIMENTAL

Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks

Drug: Fluvastatin sodium

Fluvastatin sodium Immediate Release Capsule

ACTIVE COMPARATOR

Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks

Drug: Fluvastatin sodium

Interventions

Fluvastatin sodiumDRUG

Fluvastatin sodium Extended Release Tablets 80mg

Fluvastatin sodium Extended Release TabletFluvastatin sodium Immediate Release Capsule

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with primary hypercholesterolemia or mixed dyslipidemia at moderate or high CV risk according to Chinese Dyslipidemia Guideline (2007).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Changsha, Hunan, 410011, China

Location

MeSH Terms

Conditions

Lipid Metabolism DisordersDyslipidemias

Interventions

Fluvastatin

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
trialandresults.registries@novartis.com
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2012

First Posted

March 12, 2012

Study Start

January 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

August 13, 2015

Results First Posted

June 11, 2014

Record last verified: 2015-08

Locations

CN(1)