NCT00644670

Brief Summary

The purpose of the study is to evaluate the effectiveness of atorvastatin in lowering cholesterol and getting these high risk patients to their goals of LDL \<115 mg/dl across starting doses of 10 mg, 20 mg, or 40 mg with one step titration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
232

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2003

Shorter than P25 for phase_4

Geographic Reach
1 country

17 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

June 1, 2003

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2008

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

First QC Date

March 24, 2008

Last Update Submit

February 17, 2021

Conditions

Dyslipidemias

Outcome Measures

Primary Outcomes (1)

  • Percentage of subjects in entire group who achieved low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL

    Week 12

Secondary Outcomes (7)

  • Mean percent change from baseline in LDL-C, high-density lipoprotein cholesterol (HDL-C), non-HDL-C (triglycerides of >200 mg/dL), total cholesterol, triglycerides, and apolipoprotein B for statin-naive patients

    Weeks 6 and 12

  • Proportion of subjects across different LDL-C strata who achieved LDL-C target

    Week 6

  • Proportion of diabetic subjects in entire group who achieved LDL-C target

    Week 12

  • Proportion of subject on statin therapy at baseline who achieved LDL-C target and total cholesterol target (<190 mg/dL)

    Week 12

  • Change from baseline in hemoglobin A1c levels

    Week 12

  • +2 more secondary outcomes

Study Arms (2)

Previous Treatment with a Usual Maintenance Dose of a Statin

EXPERIMENTAL
Drug: Atorvastatin

Statin-Naive

EXPERIMENTAL
Drug: Atorvastatin

Interventions

AtorvastatinDRUG

In previously treated patients, starting atorvastatin doses (oral tablets given once daily) of 20 mg (in patients with LDL-C levels between 115 and 164 mg/dL at baseline) or 40 mg (in patients with LDL-C levels between 165 and 235 mg/dL at baseline) were given for 6 weeks. If LDL-C target was achieved at Week 6, doses remained the same. If LDL-C target was not achieved at Week 6, doses were doubled.

Previous Treatment with a Usual Maintenance Dose of a Statin

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dyslipidemia
  • At a high risk for coronary heart disease

You may not qualify if:

  • Use of higher than usual maintenance doses of statin drugs at screening
  • Uncontrolled diabetes or high blood pressure
  • Impaired liver function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Pfizer Investigational Site

Antwerp, 2018, Belgium

Location

Pfizer Investigational Site

Brasschaat, 2930, Belgium

Location

Pfizer Investigational Site

Brussels, 1180, Belgium

Location

Pfizer Investigational Site

Edegem, 2650, Belgium

Location

Pfizer Investigational Site

Genk, B-3600, Belgium

Location

Pfizer Investigational Site

Ghent, 9000, Belgium

Location

Pfizer Investigational Site

Gilly (charleroi), 6060, Belgium

Location

Pfizer Investigational Site

La Louvière, 7100, Belgium

Location

Pfizer Investigational Site

Liège, 4000, Belgium

Location

Pfizer Investigational Site

Mechelen, 2800, Belgium

Location

Pfizer Investigational Site

Menen, 8930, Belgium

Location

Pfizer Investigational Site

Merksem, 2170, Belgium

Location

Pfizer Investigational Site

Mortsel, 2640, Belgium

Location

Pfizer Investigational Site

Roeselare, 8800, Belgium

Location

Pfizer Investigational Site

Seraing, 4100, Belgium

Location

Pfizer Investigational Site

Wilrijk, 2610, Belgium

Location

Pfizer Investigational Site

Wingene, 8750, Belgium

Location

Related Links

MeSH Terms

Conditions

Dyslipidemias

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2008

First Posted

March 27, 2008

Study Start

June 1, 2003

Study Completion

March 1, 2004

Last Updated

February 18, 2021

Record last verified: 2021-02

Locations

BE(17)