Effect of Ezetimibe Treatment on Low-density Lipoprotein Cholesterol (LDL-C) Levels in Participants With Coronary Heart Disease (CHD) Already Treated With a Statin (MK-0653A-205 AM1)

NCT01381679 | Completed Results

• 1 other identifier: 0653A-205
• Study Type: observational
• Target: 1,682
• Locations: 0 countries
• Sites: N/A

Brief Summary

This non-interventional longitudinal study is a follow-up of the Austrian Cholesterol Screening and Treatment project (ACT I), which assessed the cholesterol status, including achievement of the target levels applicable at that time (LDL levels \<100 mg/dL), in participants with coronary heart disease (CHD) already being treated with a statin. In this study, participants without adequate LDL-cholesterol reduction with a statin underwent extension of therapy with ezetimibe with the goal of achieving target levels.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level

  Individual LDL-C target values were set according to the Austrian Cholesterol Consensus (ACC) 2007 for patients for patients suffering from coronary heart disease (CHD) or CHD equivalent in an office-based, routine medical care setting. Participants were categorized as either high-risk or very high-risk based on ACC criteria. The LDL-C target levels for each category were 100 mg/dL and 70 mg/dL, respectively

  Up to 12 months

Secondary Outcomes (8)

• Change From Baseline in Total Cholesterol (TC) at Month 3

  Baseline and Month 3

• Change From Baseline in TC at Month 12

  Baseline and Month 12

• Change From Baseline in LDL-C at Month 3

  Baseline and Month 3

• Change From Baseline in LDL-C at Month 12

  Baseline and Month 12

• Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3

  Baseline and Month 3

Study Arms (1)

All participants

Participants in whom LDL-C target levels have not been achieved and for whom ezetimibe therapy has been chosen.

Drug: Ezetimibe

Interventions

Ezetimibe DRUG

Ezetimibe was not mandatory and was prescribed as per routine prescription by physician.

All participants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants without adequate LDL-cholesterol reduction with a statin, representative cross-section across all regions/parts of Austria (federal provinces, urban/rural areas, office-based internists/general practitioners)

You may qualify if:

• Participants in whom LDL-cholesterol target levels have not been achieved.
• Participants in whom a decision has been made by the physician to initiate treatment
• with ezetimibe (longitudinal analyses). The treatment decision will be made prior to
• \- Participants with LDL cholesterol levels ≤113 mg/dl and a very high risk, which led to case-by-case approval of medication may be documented.

You may not qualify if:

• Any condition which, in the opinion of the treating physician, precludes treatment with ezetimibe.
• In order not to interfere with data collection it is recommended not to include participants currently in a clinical trial.
• Previous and ongoing treatment with ezetimibe.

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (2)

• Pichler M, Lautsch D, Adler C, Bogl K, Drexel H, Eber B, Fauer C, Fochterle J, Foger B, Gansch K, Grafinger P, Lechleitner M, Ludvik B, Maurer G, Morz R, Paulweber B, Pfeiffer KP, Prager R, Stark G, Toplak H, Traindl O, Weitgasser R. Are there differences in LDL-C target value attainment in Austrian federal states? Yes! Wien Med Wochenschr. 2013 Dec;163(23-24):528-35. doi: 10.1007/s10354-013-0219-z. Epub 2013 Aug 27.

  PMID: 23979353 DERIVED

• Eber B, Lautsch D, Fauer C, Drexel H, Pfeiffer KP, Traindl O, Pichler M. Can LDL-cholesterol targets be achieved in a population at high risk? Results of the non-interventional study ACT II. Curr Med Res Opin. 2012 Sep;28(9):1447-54. doi: 10.1185/03007995.2012.717919. Epub 2012 Aug 16.

  PMID: 22856551 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Ezetimibe

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: June 27, 2011
• Study Start: May 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 9, 2022
• Results First Posted: March 22, 2012

Record last verified: 2022-02