NCT00125125

Brief Summary

The purpose of the study is to find a good therapy for patients who need to be treated for high cholesterol and who have difficulty tolerating other statins (such as pravastatin, simvastatin, lovastatin, atorvastatin, rosuvastatin) due to muscle pain.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
218

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2005

Shorter than P25 for phase_4

Geographic Reach
2 countries

2 active sites

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

May 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

7 months

First QC Date

July 28, 2005

Last Update Submit

May 15, 2017

Conditions

Dyslipidemia

Keywords

Dyslipidemia, adults, fluvastatin

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in low density lipoprotein cholesterol after 12 weeks

Secondary Outcomes (4)

  • Tolerability as assessed by muscle-related adverse events, and muscle-related adverse events leading to discontinuation

  • Change from baseline in total cholesterol, triglycerides, high density lipoprotein cholesterol, and lipoprotein subtypes after 12 weeks

  • Number of patients who reach target LDL after 12 weeks

  • Change from baseline in marker of inflammation after 12 weeks

Interventions

FluvastatinDRUG

Eligibility Criteria

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

You may qualify if:

  • Dyslipidemia
  • History of Myalgia

You may not qualify if:

  • Previous treatment with fluvastatin
  • Age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novartis

East Hanover, New Jersey, 07936, United States

Location

Unknown Facility

Investigative Centers, Germany

Location

Related Publications (1)

  • Stein EA, Ballantyne CM, Windler E, Sirnes PA, Sussekov A, Yigit Z, Seper C, Gimpelewicz CR. Efficacy and tolerability of fluvastatin XL 80 mg alone, ezetimibe alone, and the combination of fluvastatin XL 80 mg with ezetimibe in patients with a history of muscle-related side effects with other statins. Am J Cardiol. 2008 Feb 15;101(4):490-6. doi: 10.1016/j.amjcard.2007.09.099. Epub 2007 Dec 20.

    PMID: 18312764DERIVED

MeSH Terms

Conditions

Dyslipidemias

Interventions

Fluvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

July 28, 2005

First Posted

July 29, 2005

Study Start

May 1, 2005

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

May 17, 2017

Record last verified: 2017-05

Locations

US(1)DE(1)