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A Study Of Atorvastatin For The Treatment Of High Cholesterol In Patients At High Risk Of Coronary Heart Disease (CHD)

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:

Completion of base study
Dyslipidemia and at high risk of CHD

Exclusion Criteria:

Impaired liver function
Gastrointestinal disease that could limit drug absorption

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm A

Arm Description

Outcomes

Primary Outcome Measures

Achievement of low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL

Secondary Outcome Measures

Achievement of LDL-C target and total cholesterol target (<190 mg/dL) concomitantly

LDL-C, high-density lipoprotein cholesterol (HDL-C), total cholesterol, and triglyceride levels

Percent change from baseline of base study in LDL-C, HDL-C, non-HDL-C (triglycerides of >200 mg/dL), total cholesterol, and triglycerides in patients who were statin-naive at baseline of base study

Achievement of LDL-C target grouped according to whether patients had achieved target at the start of this extension study

Adverse events and laboratory test changes

Achievement of LDL-C target

Achievement of LDL-C target by diabetic patients

Full Information

NCT ID

NCT00644709

First Posted

March 25, 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

NCT00644709

Brief Title

A Study Of Atorvastatin For The Treatment Of High Cholesterol In Patients At High Risk Of Coronary Heart Disease (CHD)

Official Title

A Multicenter, Open-Label Extension Study Of High-Risk Hyperlipidemic Patients Treated With An Atorvastatin Starting Dose Adapted To Their Baseline LDL-C Level

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

September 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2005 (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

A study of the long-term (1 year) effectiveness of atorvastatin to keep patients of high cardiovascular risk at the LDL cholesterol goal of <115 mg/dL

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

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

196 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Atorvastatin

Intervention Description

Atorvastatin tablets at starting doses of 10, 20, 40, or 80 mg once daily. Three dose adjustments were allowed at baseline, Week 17, and Week 34. Patients who did not meet the LDL-C target at any of these time points had their doses doubled except for those who were on the 80 mg dose. Treatment was given for 52 weeks.

Primary Outcome Measure Information:

Title

Achievement of low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL

Time Frame

Week 52

Secondary Outcome Measure Information:

Title

Achievement of LDL-C target and total cholesterol target (<190 mg/dL) concomitantly

Time Frame

Week 52

Title

LDL-C, high-density lipoprotein cholesterol (HDL-C), total cholesterol, and triglyceride levels

Time Frame

Baseline and Week 6 for base study; Baseline and Weeks 17, 34, and 52 for extension study

Title

Percent change from baseline of base study in LDL-C, HDL-C, non-HDL-C (triglycerides of >200 mg/dL), total cholesterol, and triglycerides in patients who were statin-naive at baseline of base study

Time Frame

Baseline and Weeks 17, 34, and 52

Title

Achievement of LDL-C target grouped according to whether patients had achieved target at the start of this extension study

Time Frame

Week 52

Title

Adverse events and laboratory test changes

Time Frame

Weeks 17, 34, and 52

Title

Achievement of LDL-C target

Time Frame

Weeks 17 and 34

Title

Achievement of LDL-C target by diabetic patients

Time Frame

Week 52

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: Completion of base study Dyslipidemia and at high risk of CHD Exclusion Criteria: Impaired liver function Gastrointestinal disease that could limit drug absorption

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

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

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=A2581112&StudyName=A%20Study%20Of%20Lipitor%20For%20The%20Treatment%20Of%20High%20Cholesterol%20In%20Patients%20At%20High%20Risk%20Of%20Coronary%20Heart%20Disease%20%28CHD%29

Description

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Learn more about this trial

A Study Of Atorvastatin For The Treatment Of High Cholesterol In Patients At High Risk Of Coronary Heart Disease (CHD)

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A Study Of Atorvastatin For The Treatment Of High Cholesterol In Patients At High Risk Of Coronary Heart Disease (CHD)

Dyslipidemias

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

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