NCT00644709

Brief Summary

A study of the long-term (1 year) effectiveness of atorvastatin to keep patients of high cardiovascular risk at the LDL cholesterol goal of \<115 mg/dL

Trial Health

87
On Track

Trial Health Score

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

Enrollment
196

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2003

Geographic Reach
1 country

15 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

September 1, 2003

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2008

Completed
2 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 25, 2008

Last Update Submit

February 17, 2021

Conditions

Dyslipidemias

Outcome Measures

Primary Outcomes (1)

  • Achievement of low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL

    Week 52

Secondary Outcomes (7)

  • Achievement of LDL-C target and total cholesterol target (<190 mg/dL) concomitantly

    Week 52

  • LDL-C, high-density lipoprotein cholesterol (HDL-C), total cholesterol, and triglyceride levels

    Baseline and Week 6 for base study; Baseline and Weeks 17, 34, and 52 for extension study

  • Percent change from baseline of base study in LDL-C, HDL-C, non-HDL-C (triglycerides of >200 mg/dL), total cholesterol, and triglycerides in patients who were statin-naive at baseline of base study

    Baseline and Weeks 17, 34, and 52

  • Achievement of LDL-C target grouped according to whether patients had achieved target at the start of this extension study

    Week 52

  • Adverse events and laboratory test changes

    Weeks 17, 34, and 52

  • +2 more secondary outcomes

Study Arms (1)

Arm A

EXPERIMENTAL
Drug: Atorvastatin

Interventions

AtorvastatinDRUG

Atorvastatin tablets at starting doses of 10, 20, 40, or 80 mg once daily. Three dose adjustments were allowed at baseline, Week 17, and Week 34. Patients who did not meet the LDL-C target at any of these time points had their doses doubled except for those who were on the 80 mg dose. Treatment was given for 52 weeks.

Arm A

Eligibility Criteria

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

You may qualify if:

  • Completion of base study
  • Dyslipidemia and at high risk of CHD

You may not qualify if:

  • Impaired liver function
  • Gastrointestinal disease that could limit drug absorption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Pfizer Investigational Site

Antwerp, 2018, Belgium

Location

Pfizer Investigational Site

Brasschaat, 2930, Belgium

Location

Pfizer Investigational Site

Brussels, 1180, 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

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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2008

First Posted

March 27, 2008

Study Start

September 1, 2003

Study Completion

March 1, 2005

Last Updated

February 18, 2021

Record last verified: 2021-02

Locations

BE(15)