Clinical trial NCT00645151: A Study Of The Efficacy Of Atorvastatin In Lowering Cholesterol In Latin American Patients With High Cholesterol
Official title: A Multicenter, Eight-Week Treatment, Single Step Titration, Open-Label Study Assessing The Percentage Of Subjects Achieving Low Density Lipoprotein Cholesterol Target With Atorvastatin Starting Doses Of 10 Mg, 20 Mg, 40 Mg, And 80 Mg (Latin American Atorvastatin ATGOAL Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyslipidemias
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 512
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Responder rate in patients who achieved low-density lipoprotein cholesterol (LDL-C) level
timeFrame: Week 8
Secondary outcomes:
measure: Percentage of patients achieving LDL goal at 2 and 4 weeks
timeFrame: Weeks 2 and 4
measure: Lipid changes at week 4 & 8
timeFrame: Weeks 4 and 8
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Pfizer Investigational Site
state: MG
city: Curitiba
country: Brazil
facility: Pfizer Investigational Site
state: PR
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: São José
country: Brazil
facility: Pfizer Investigational Site
state: SC
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP/Brazil
city: Campinas
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Campinas
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: São José do Rio Preto
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
city: Santiago
country: Chile
facility: Pfizer Investigational Site
state: Región Metropolitana
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: Bogotá
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: Barranquilla
country: Colombia
facility: Pfizer Investigational Site
city: Bogotá, C/marca
country: Colombia
facility: Pfizer Investigational Site
city: Cali, Valle
country: Colombia
facility: Pfizer Investigational Site
city: Quito
country: Ecuador
facility: Pfizer Investigational Site
state: Pichincha / Ecuador
city: Guatemala
country: Guatemala
facility: Pfizer Investigational Site
city: Guadalajara
country: Mexico
facility: Pfizer Investigational Site
state: Jalisco
city: Zapopan
country: Mexico
facility: Pfizer Investigational Site
state: Jalisco
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon
city: Chihuahua
country: Mexico
facility: Pfizer Investigational Site
city: Durango
country: Mexico
facility: Pfizer Investigational Site
city: Panama
country: Panama
facility: Pfizer Investigational Site
city: Dtto. Federal
country: Venezuela
facility: Pfizer Investigational Site
state: Caracas
city: Caracas
country: Venezuela
facility: Pfizer Investigational Site
state: Dtto Federal
city: Caracas
country: Venezuela
facility: Pfizer Investigational Site
state: Dtto Federal
city: Caracas
country: Venezuela
facility: Pfizer Investigational Site
state: Edo. Miranda
city: Caracas
country: Venezuela
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: