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Atorvastatin Study For The Treatment Of High Cholesterol In Patients From Thailand

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00647543
First received: March 26, 2008
Last updated: April 28, 2008
Last verified: April 2008
  Purpose

The purpose of this study is to evaluate the efficacy of atorvastatin in lowering cholesterol on patients from Thailand with high cholesterol.


Condition Intervention Phase
Dyslipidemias
Drug: Atorvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Eight-Week Treatment, Single-Step Titration, Open-Label Study Assessing The Percentage Of Dyslipidemic Patients Achieving LDL Cholesterol Target With Atorvastatin Starting Doses Of 10 Mg, 20 Mg, And 40 Mg

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of patients who achieved low-density lipoprotein cholesterol (LDL-C) target [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events and laboratory test changes [ Time Frame: Weeks 2, 4, and 8 ] [ Designated as safety issue: Yes ]
  • Percentage of patients who achieved LDL-C target [ Time Frame: Weeks 2 and 4, and Week 8 with 1 step titration ] [ Designated as safety issue: No ]
  • Change and percent change from baseline in LDL-C [ Time Frame: Weeks 2, 4, and 8 ] [ Designated as safety issue: No ]
  • Change and percent change from baseline in high-density lipoprotein cholesterol (HDL-C) [ Time Frame: Weeks 2, 4, and 8 ] [ Designated as safety issue: No ]
  • Change and percent change from baseline in LDL/HDL ratio [ Time Frame: Weeks 2, 4, and 8 ] [ Designated as safety issue: No ]
  • Change and percent change from baseline in total cholesterol [ Time Frame: Weeks 2, 4, and 8 ] [ Designated as safety issue: No ]
  • Change and percent change from baseline in triglycerides [ Time Frame: Weeks 2, 4, and 8 ] [ Designated as safety issue: No ]

Enrollment: 242
Study Start Date: August 2003
Study Completion Date: April 2004
Arms Assigned Interventions
Experimental: High Risk Drug: Atorvastatin
Atorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks.
Experimental: Low Risk Drug: Atorvastatin
Atorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks.
Experimental: Medium Risk Drug: Atorvastatin
Atorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dyslipidemic patients who were eligible for lipid lowering therapy
  • Willingness to follow study diet for 1 month prior to screening and for the duration of the study

Exclusion Criteria:

  • Use of other lipid lowering agents (6-week washout period)
  • Uncontrolled high blood pressure
  • Impaired liver function
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00647543

Locations
Thailand
Pfizer Investigational Site
Unknown, Bangkok, Thailand, 10400
Pfizer Investigational Site
Unknown, Bangkok, Thailand
Pfizer Investigational Site
Unknown, Bangkok, Thailand, 10330
Pfizer Investigational Site
Bangkok, Thailand, 10400
Pfizer Investigational Site
Bangkok, Thailand, 10700
Pfizer Investigational Site
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00647543     History of Changes
Other Study ID Numbers: A2581111
Study First Received: March 26, 2008
Last Updated: April 28, 2008
Health Authority: Thailand: Food and Drug Administration

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014