A Study Of The Efficacy Of Atorvastatin For Lowering Cholesterol In High-Risk Patients With High Cholesterol

NCT00644670

Last updated date
Study Location
Pfizer Investigational Site
Antwerpen, , 2018, Belgium
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Dyslipidemias
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
30-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Dyslipidemia

- At a high risk for coronary heart disease

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Use of higher than usual maintenance doses of statin drugs at screening


- Uncontrolled diabetes or high blood pressure


- Impaired liver function

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

DyslipidemiasLipitor Korean Atorvastatin Goal Achievement Across Risk Levels Study
NCT00540293
  1. Daegu, Korea
  2. Seoul, Korea
  3. Busan,
  4. Busan,
  5. Daegu,
  6. Daejeon,
  7. Gwangju,
  8. Gwangju,
  9. Gyeonggi-do,
  10. Gyeonggi-do,
  11. Incheon,
  12. Kyunggi-do,
  13. Seoul,
  14. Seoul,
  15. Seoul,
  16. Seoul,
  17. Seoul,
  18. Seoul,
  19. Seoul,
  20. Seoul,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
DyslipidemiasA Study Of The Efficacy Of Atorvastatin For Lowering Cholesterol In High-Risk Patients With High Cholesterol
NCT00644670
  1. Antwerpen,
  2. Brasschaat,
  3. Brussels,
  4. Edegem,
  5. Genk,
  6. Gent,
  7. Gilly (charleroi),
  8. La Louvière,
  9. Liège,
  10. Mechelen,
  11. Menen,
  12. Merksem,
  13. Mortsel,
  14. Roeselare,
  15. Seraing,
  16. Wilrijk,
  17. Wingene,
ALL GENDERS
30 Years+
years
MULTIPLE SITES
DyslipidemiasA Study Of Atorvastatin For The Treatment Of High Cholesterol In Patients At High Risk Of Coronary Heart Disease (CHD)
NCT00644709
  1. Antwerpen,
  2. Brasschaat,
  3. Brussels,
  4. Genk,
  5. Gent,
  6. Gilly (charleroi),
  7. La Louvière,
  8. Mechelen,
  9. Menen,
  10. Merksem,
  11. Mortsel,
  12. Roeselare,
  13. Seraing,
  14. Wilrijk,
  15. Wingene,
ALL GENDERS
30 Years+
years
MULTIPLE SITES
DyslipidemiasA Study Of The Efficacy Of Atorvastatin In Lowering Cholesterol In Latin American Patients With High Cholesterol
NCT00645151
  1. Belo Horizonte, MG
  2. Curitiba, PR
  3. Porto Alegre, RS
  4. Porto Alegre, RS
  5. São José, SC
  6. São Paulo, SP/Brazil
  7. Campinas, SP
  8. Campinas, SP
  9. Sao Paulo, SP
  10. Sao Paulo, SP
  11. São José do Rio Preto, SP
  12. São Paulo, SP
  13. Rio de Janeiro,
  14. Santiago, Región Metropolitana
  15. Bogota, Cundinamarca
  16. Bogotá, Cundinamarca
  17. Barranquilla,
  18. Bogotá, C/marca,
  19. Cali, Valle,
  20. Quito, Pichincha / Ecuador
  21. Guatemala,
  22. Guadalajara, Jalisco
  23. Zapopan, Jalisco
  24. Monterrey, Nuevo Leon
  25. Monterrey, Nuevo Leon
  26. Chihuahua,
  27. Durango,
  28. Panama,
  29. Dtto. Federal, Caracas
  30. Caracas, Dtto Federal
  31. Caracas, Dtto Federal
  32. Caracas, Edo. Miranda
  33. Caracas,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of The Efficacy Of Atorvastatin For Lowering Cholesterol In High-Risk Patients With High Cholesterol
Official Title  ICMJE A Multicenter, Twelve-Week Treatment, Single-Step Titration, Open-Label Study Assessing The Percentage Of Dyslipidemic High-Risk Patients Achieving LDL Cholesterol Targets With Atorvastatin Starting Doses Of 10 Mg, 20 Mg And 40 Mg.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dyslipidemias
Intervention  ICMJE
  • Drug: Atorvastatin
    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.
  • Drug: Atorvastatin
    In statin-naive patients, starting atorvastatin doses (oral tablets given once daily) of 10 mg (in patients with LDL-C levels between 115 and 164 mg/dL at baseline), 20 mg (in patients with LDL-C levels between 165 and 174 mg/dL at baseline), or 40 mg (in patients with LDL-C levels between 175 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.
Study Arms  ICMJE
  • Experimental: Previous Treatment with a Usual Maintenance Dose of a Statin
    Intervention: Drug: Atorvastatin
  • Experimental: Statin-Naive
    Intervention: Drug: Atorvastatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2008)
232
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Dyslipidemia
  • At a high risk for coronary heart disease

Exclusion Criteria:

  • Use of higher than usual maintenance doses of statin drugs at screening
  • Uncontrolled diabetes or high blood pressure
  • Impaired liver function
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00644670
Other Study ID Numbers  ICMJE A2581099
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP