LAPLACE-TIMI 57: LDL-C Assessment Wtih PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy

This study has been completed.

Sponsor:

Collaborator:

TIMI Study Group

Information provided by (Responsible Party):

Amgen

ClinicalTrials.gov Identifier:

NCT01380730

First received: June 23, 2011

Last updated: April 2, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 23, 2011

Last Updated Date

April 2, 2013

Start Date ^ICMJE

July 2011

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary endpoint is the percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

The primary endpoint is the percent change from baseline in LDL-C at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01380730 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Absolute change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in non-High Density Lipoprotein Cholesterol (HDL-C) at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in Apolipoprotein B (ApoB) at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in the total cholesterol/High Density Lipoprotein Cholesterol (HDL-C) ratio at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in Apolipoprotein B (ApoB)/Apolipoprotein A-1 (ApoA1) ratio at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Percent change from baseline in non-HDL-C at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in ApoB at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in the total cholesterol/HDL-C ratio at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in ApoB/ApoA1 ratio at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Absolute change from baseline in LDL-C at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

LAPLACE-TIMI 57: LDL-C Assessment Wtih PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy

Official Title ^ICMJE

TIMI-57 - A Double-blind, Randomized, Placebo-controlled, Multicenter, Dose-ranging Study to Evaluate Tolerability and Efficacy of AMG 145 on Low-Density Lipoprotein Cholesterol (LDL-C) in Combination With HMG-CoA Reductase Inhibitors in Hypercholesterolemic Subjects

Brief Summary

To evaluate the effect of 12 weeks of subcutaneous (SC) AMG 145 every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, or percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) when used in addition to a statin in subjects with hypercholesterolemia.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Hyperlipidemia

Intervention ^ICMJE

Drug: AMG 145
Dose 1 - every 2 weeks
Drug: AMG 145
Dose 2 - every 2 weeks
Drug: AMG 145
Dose 3 - every 2 weeks
Drug: AMG 145
Dose 4 - every 4 weeks
Drug: AMG 145
Dose 5 - every 4 weeks
Drug: AMG 145
Dose 6 - every 4 weeks
Drug: PLACEBO
Dose 7 - every 2 weeks
Drug: PLACEBO
Dose 8 - every 4 weeks

Study Arm (s)

Experimental: Group 4
AMG 145

Intervention: Drug: AMG 145
Placebo Comparator: Group 7
Placebo

Intervention: Drug: PLACEBO
Experimental: Group 1
AMG 145

Intervention: Drug: AMG 145
Experimental: Group 5
AMG 145

Intervention: Drug: AMG 145
Experimental: Group 3
AMG 145

Intervention: Drug: AMG 145
Experimental: Group 6
AMG 145

Intervention: Drug: AMG 145
Placebo Comparator: Group 8
Placebo

Intervention: Drug: PLACEBO
Experimental: Group 2
AMG 145

Intervention: Drug: AMG 145

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

631

Completion Date

May 2012

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or female ≥ 18 to ≤ 80 years of age
On an approved statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks
Fasting Low-Density Lipoprotein Cholesterol (LDL-C) ≥ 85 mg/dL
Fasting triglycerides ≤ 400 mg/dL

Exclusion Criteria:

Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization
Type 1 diabetes; newly diagnosed or poorly controlled type 2 diabetes (Glycated Hemoglobin (HbA1c) > 8.5%)
Uncontrolled hypertension defined
New York Heart Association (NYHA) III or IV heart failure, or known left ventricular ejection fraction < 30%
Uncontrolled cardiac arrhythmia

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, Czech Republic, Denmark, Hungary

Administrative Information

NCT Number ^ICMJE

NCT01380730

Other Study ID Numbers ^ICMJE

20101155

Has Data Monitoring Committee

Yes

Responsible Party

Amgen

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

TIMI Study Group

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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