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

Primary Purpose

Dyslipidemias

Status

Completed

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

Atorvastatin

About this trial

This is an interventional treatment trial for Dyslipidemias

Eligibility Criteria

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

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Previous Treatment with a Usual Maintenance Dose of a Statin

Statin-Naive

Arm Description

Outcomes

Primary Outcome Measures

Percentage of subjects in entire group who achieved low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL

Secondary Outcome Measures

Mean percent change from baseline in LDL-C, high-density lipoprotein cholesterol (HDL-C), non-HDL-C (triglycerides of >200 mg/dL), total cholesterol, triglycerides, and apolipoprotein B for statin-naive patients

Proportion of subjects across different LDL-C strata who achieved LDL-C target

Proportion of diabetic subjects in entire group who achieved LDL-C target

Proportion of subject on statin therapy at baseline who achieved LDL-C target and total cholesterol target (<190 mg/dL)

Change from baseline in hemoglobin A1c levels

Adverse events and laboratory test changes

Proportion of subjects in entire group who achieved LDL-C target

Full Information

NCT ID

NCT00644670

First Posted

March 24, 2008

Last Updated

February 17, 2021

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00644670

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

June 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2004 (Actual)

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

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

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

Dyslipidemias

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

232 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Previous Treatment with a Usual Maintenance Dose of a Statin

Arm Type

Experimental

Arm Title

Statin-Naive

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Atorvastatin

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Atorvastatin

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percentage of subjects in entire group who achieved low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Time Frame

Weeks 6 and 12

Title

Proportion of subjects across different LDL-C strata who achieved LDL-C target

Time Frame

Week 6

Title

Proportion of diabetic subjects in entire group who achieved LDL-C target

Time Frame

Week 12

Title

Proportion of subject on statin therapy at baseline who achieved LDL-C target and total cholesterol target (<190 mg/dL)

Time Frame

Week 12

Title

Change from baseline in hemoglobin A1c levels

Time Frame

Week 12

Title

Adverse events and laboratory test changes

Time Frame

Weeks 6 and 12

Title

Proportion of subjects in entire group who achieved LDL-C target

Time Frame

Week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

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

Antwerpen

ZIP/Postal Code

2018

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Brasschaat

ZIP/Postal Code

2930

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Brussels

ZIP/Postal Code

1180

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Genk

ZIP/Postal Code

B-3600

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Gilly (charleroi)

ZIP/Postal Code

6060

Country

Belgium

Facility Name

Pfizer Investigational Site

City

La Louvière

ZIP/Postal Code

7100

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Mechelen

ZIP/Postal Code

2800

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Menen

ZIP/Postal Code

8930

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Merksem

ZIP/Postal Code

2170

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Mortsel

ZIP/Postal Code

2640

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Seraing

ZIP/Postal Code

4100

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Wilrijk

ZIP/Postal Code

2610

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Wingene

ZIP/Postal Code

8750

Country

Belgium

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2581099&StudyName=A%20Study%20Of%20The%20Efficacy%20Of%20Lipitor%20For%20Lowering%20Cholesterol%20In%20High-Risk%20Patients%20With%20High%20Cholesterol

Description

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

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

Dyslipidemias

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial