NCT00645151

Brief Summary

The purpose of this study is to determine the percentage of patients who would reach a cholesterol goal after atorvastatin treatment.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
512

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2004

Shorter than P25 for phase_4

Geographic Reach
8 countries

33 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

April 1, 2004

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 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)

  • Responder rate in patients who achieved low-density lipoprotein cholesterol (LDL-C) level

    Week 8

Secondary Outcomes (2)

  • Percentage of patients achieving LDL goal at 2 and 4 weeks

    Weeks 2 and 4

  • Lipid changes at week 4 & 8

    Weeks 4 and 8

Study Arms (3)

High Risk

EXPERIMENTAL
Drug: Atorvastatin

Low Risk

EXPERIMENTAL
Drug: Atorvastatin

Medium Risk

EXPERIMENTAL
Drug: Atorvastatin

Interventions

AtorvastatinDRUG

Atorvastatin calcium 10, 20, 40, or 80 mg tablets (dose dependent on individual risk factors and baseline LDL-C level) once daily for 4 weeks. After 4 weeks of treatment, subjects who did not achieve the LDL-C target goal were up-titrated to 20, 40, or 80 mg and subjects who achieved their LDL-target goal remained on the same dose for the following 4 weeks.

High Risk

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with high cholesterol eligible for treatment with baseline LDL-C level of less than or equal to 220 mg/dL
  • Willingness to follow diet

You may not qualify if:

  • Triglycerides less than or equal to 400 mg/dL
  • Hemoglobin A1c \>10%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

Pfizer Investigational Site

Belo Horizonte, Minas Gerais, Brazil

Location

Pfizer Investigational Site

Curitiba, Paraná, 80540-010, Brazil

Location

Pfizer Investigational Site

Porto Alegre, Rio Grande do Sul, 90035-170, Brazil

Location

Pfizer Investigational Site

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Pfizer Investigational Site

São José, Santa Catarina, 88103-460, Brazil

Location

Pfizer Investigational Site

São Paulo, SP/Brazil, 04039-001, Brazil

Location

Pfizer Investigational Site

Campinas, São Paulo, 13012-000, Brazil

Location

Pfizer Investigational Site

Campinas, São Paulo, 13059-740, Brazil

Location

Pfizer Investigational Site

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 01244-030, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 04012-180, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, Brazil

Location

Pfizer Investigational Site

Rio de Janeiro, 20550-030, Brazil

Location

Pfizer Investigational Site

Santiago, Santiago Metropolitan, Chile

Location

Pfizer Investigational Site

Bogota, Cundinamarca, Colombia

Location

Pfizer Investigational Site

Bogotá, Cundinamarca, Colombia

Location

Pfizer Investigational Site

Barranquilla, Colombia

Location

Pfizer Investigational Site

Bogotá, C/marca, Colombia

Location

Pfizer Investigational Site

Cali, Valle, Colombia

Location

Pfizer Investigational Site

Quito, Pichincha / Ecuador, Ecuador

Location

Pfizer Investigational Site

Guatemala City, 01015, Guatemala

Location

Pfizer Investigational Site

Guadalajara, Jalisco, 44290, Mexico

Location

Pfizer Investigational Site

Zapopan, Jalisco, 45200, Mexico

Location

Pfizer Investigational Site

Monterrey, Nuevo León, 64060, Mexico

Location

Pfizer Investigational Site

Monterrey, Nuevo León, 64410, Mexico

Location

Pfizer Investigational Site

Chihuahua City, 31238, Mexico

Location

Pfizer Investigational Site

Durango, 34300, Mexico

Location

Pfizer Investigational Site

Panama City, Panama

Location

Pfizer Investigational Site

Caracas, Dtto Federal, 1061, Venezuela

Location

Pfizer Investigational Site

Caracas, Dtto Federal, 1081, Venezuela

Location

Pfizer Investigational Site

Caracas, Edo. Miranda, 1061, Venezuela

Location

Pfizer Investigational Site

Dtto. Federal, Miranda, 1020, Venezuela

Location

Pfizer Investigational Site

Caracas, 1020, Venezuela

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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2008

First Posted

March 27, 2008

Study Start

April 1, 2004

Study Completion

February 1, 2005

Last Updated

February 18, 2021

Record last verified: 2021-02

Locations

CL(1)EC(1)GU(1)CO(5)VE(5)PA(1)ME(6)BR(13)