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A Swiss Study With Atorvastatin in Hyperlipidemic Patients Measuring LDL-Cholesterol (ACTFAST SWISS)

Primary Purpose

Hyperlipidemia

Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Atorvastatin
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Risk factors and diagnosis of dyslipidemia according to the AGLA-recommendations (see appendix B) at screening LDL-C < 6.0 mmol/l Triglyceride level < 5.0 mmol/l. Exclusion Criteria: Subjects receiving higher than "usual maintenance" doses of Lipid Lowering Therapy (LLT) at screening.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

The proportion of patients achieving LDL-C target as defined by local swiss AGLArecommendations across starting doses of 10 mg, 20 mg, 40 mg, and 80 mg of atorvastatin.

Secondary Outcome Measures

The proportion of patients across different AGLA-categories (primary and secondary prevention) achieving LDL-C target as defined by AGLA-recommendations across starting doses of 10 mg, 20 mg, 40 mg, and 80 mg of atorvastatin.

Full Information

First Posted
August 25, 2005
Last Updated
February 17, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00136942
Brief Title
A Swiss Study With Atorvastatin in Hyperlipidemic Patients Measuring LDL-Cholesterol
Acronym
ACTFAST SWISS
Official Title
A Multicenter, 6-Week-Treatment, Open-Label Study Assessing The Percentage Of Hyperlipidemic Patients Achieving Low Density Lipoprotein Cholesterol Target With Atorvastatin
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

Brief Summary
The proportion of patients achieving LDL-C target as defined by Swiss cholesterol recommendations (AGLA-recommendations) across starting doses of 10 mg, 20 mg, 40 mg, and 80 mg of atorvastatin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
370 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Primary Outcome Measure Information:
Title
The proportion of patients achieving LDL-C target as defined by local swiss AGLArecommendations across starting doses of 10 mg, 20 mg, 40 mg, and 80 mg of atorvastatin.
Secondary Outcome Measure Information:
Title
The proportion of patients across different AGLA-categories (primary and secondary prevention) achieving LDL-C target as defined by AGLA-recommendations across starting doses of 10 mg, 20 mg, 40 mg, and 80 mg of atorvastatin.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Risk factors and diagnosis of dyslipidemia according to the AGLA-recommendations (see appendix B) at screening LDL-C < 6.0 mmol/l Triglyceride level < 5.0 mmol/l. Exclusion Criteria: Subjects receiving higher than "usual maintenance" doses of Lipid Lowering Therapy (LLT) at screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Langenthal
State/Province
BE
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Thun
State/Province
BE
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Binningen
State/Province
BL
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Liestal
State/Province
BL
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Basel
State/Province
BS
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Duedingen
State/Province
FR
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Geneve
State/Province
GE
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Onex
State/Province
GE
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Pfaeffikon
State/Province
SZ
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Siebnen
State/Province
SZ
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Lugano
State/Province
TI
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Malvaglia
State/Province
TI
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Melide
State/Province
TI
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Vezia
State/Province
TI
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Ecublens
State/Province
VD
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Lausanne
State/Province
VD
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Prilly
State/Province
VD
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Unteraegeri
State/Province
ZG
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Zug
State/Province
ZG
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Zuerich
State/Province
ZH
Country
Switzerland

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2581089&StudyName=ACTFAST+Swiss%3A+a+Swiss+Study+with+Atorvastatin+in+Hyperlipidemic+Patients+measuring+LDL%2DCholesterol
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Swiss Study With Atorvastatin in Hyperlipidemic Patients Measuring LDL-Cholesterol

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