Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study (DESCARTES)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Amgen

ClinicalTrials.gov Identifier:

NCT01516879

First received: January 18, 2012

Last updated: May 9, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 18, 2012

Last Updated Date

May 9, 2013

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percent change from baseline in LDL-C at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Percent change from baseline in LDL-C at week 52

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01516879 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Percent change from baseline in LDL-C at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in LDL-C at week 12
Percent change from week 12 in LDL-C at week 52 [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
Percent change from week 12 in LDL-C at week 52
Absolute change from baseline in LDL-C at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Absolute change from baseline in LDL-C at week 52
Percent change from baseline in non-HDL-C at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in non-HDL-C at week 52
Percent change from baseline in ApoB at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in ApoB at week 52
Percent change from baseline in the total cholesterol/HDL-C ratio at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in the total cholesterol/HDL-C ratio at week 52
Percent change from baseline in ApoB/ApoA1 ratio at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in ApoB/ApoA1 ratio at week 52
LDL-C response (LDL-C < 70 mg/dL [1.8 mmol/L]) at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
LDL-C response (LDL-C < 70 mg/dL [1.8 mmol/L]) at week 52
Percent change from baseline in TC at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in TC at week 12
Percent change from baseline in TC at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in TC at week 52
Percent change from baseline in Lp(a) at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in Lp(a) at week 52
Percent change from baseline in triglycerides at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in triglycerides at week 52
Percent change from baseline in HDL-C at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in HDL-C at week 52
Percent change from baseline in VLDL-C at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in VLDL-C at week 52

Original Secondary Outcome Measures ^ICMJE

Percent change from baseline in LDL-C at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in LDL-C at week 12
Percent change from week 12 in LDL-C at week 52 [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
Percent change from week 12 in LDL-C at week 52
Absolute change from baseline in LDL-C at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Absolute change from baseline in LDL-C at week 52
Percent change from baseline in non-HDL-C at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in non-HDL-C at week 52
Percent change from baseline in ApoB at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in ApoB at week 52
Percent change from baseline in the total cholesterol/HDL-C ratio at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in the total cholesterol/HDL-C ratio at week 52
Percent change from baseline in ApoB/ApoA1 ratio at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in ApoB/ApoA1 ratio at week 52

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study

Official Title ^ICMJE

A Double-Blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Long-Term Tolerability and Durable Efficacy of AMG 145 on LDL-C in Hyperlipidemic Subjects

Brief Summary

To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC) AMG 145 compared with placebo when added to assigned background lipid-lowering therapy.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

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

Hypercholesterolemia

Intervention ^ICMJE

Drug: AMG 145
Subjects randomized to the AMG 145 arm will receive AMG 145 subcutaneously every 4 weeks
Other: Placebo
Subjects randomized to the placebo arm will receive Placebo subcutaneously every 4 weeks

Study Arm (s)

Experimental: AMG 145
AMG 145

Intervention: Drug: AMG 145
Placebo Comparator: Placebo
Placebo

Intervention: Other: Placebo

Publications *

Not Provided

* 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

Active, not recruiting

Enrollment ^ICMJE

905

Estimated Completion Date

April 2014

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subject has provided informed consent.
Fasting LDL-C ≥ 75 mg/dL and meeting the following LDL-C values on background lipid-lowering therapy:
- < 100 mg/dL for subjects with diagnosed CHD or CHD risk equivalent
- < 130 mg/dL for subjects without diagnosed CHD or CHD risk equivalent
- OR on maximal background lipid-lowering therapy defined as atorvastatin 80 mg PO QD and ezetimibe 10 mg PO QD
Fasting triglycerides ≤ 400 mg/dL

Exclusion Criteria:

NYHA II-IV heart failure, or last known left ventricular ejection fraction < 30%
Uncontrolled cardiac arrhythmia
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
Uncontrolled hypertension

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, Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Hungary, South Africa

Administrative Information

NCT Number ^ICMJE

NCT01516879

Other Study ID Numbers ^ICMJE

20110109

Has Data Monitoring Committee

Yes

Responsible Party

Amgen

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

May 2013

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

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