Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities (TESLA)

This study is currently recruiting participants.

Verified May 2013 by Amgen

Sponsor:

Information provided by (Responsible Party):

Amgen

ClinicalTrials.gov Identifier:

NCT01588496

First received: February 27, 2012

Last updated: May 6, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

February 27, 2012

Last Updated Date

May 6, 2013

Start Date ^ICMJE

April 2012

Estimated Primary Completion Date

October 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percent change from baseline in low density lipoprotein cholesterol at week 12 for Part A and Part B [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Percent change from baseline in low density lipoprotein-cholesterol at week 12 for Part A and Part B

Original Primary Outcome Measures ^ICMJE

Percent change from baseline in low density lipoprotein cholesterol (LDL-C) at week 12 for Part A and Part B. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01588496 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in low density lipoprotein at week 12 for Part A and Part B [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change from baseline in low density lipoprotein at week 12 for Part A and Part B
Percent change from baseline in non-high density lipoprotein cholesterol at week 12 for Part A and Part B [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in non-high density lipoprotein cholesterol at week 12 for Part A and Part B
Percent change from baseline in apolipoprotein B at week 12 for Part A and Part B [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in apolipoprotein B at week 12 for Part A and Part B
Percent change from baseline in the total cholesterol/high density lipoprotein-cholesterol ratio at week 12 for Part A and Part B [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in the total cholesterol/high density lipoprotein-cholesterol ratio at week 12 for Part A and Part B
Percent change from baseline in apolipoprotein B/apolipoprotein A1 ratio at week 12 for Part A and Part B [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in apolipoprotein B/apolipoprotein A1 ratio at week 12 for Part A and Part B
Response rate of subjects with 15% or greater reduction in low density lipoportein-cholesterolfrom baseline to Week 12 (Part A only). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Response rate of subjects with 15% or greater reduction in low density lipoportein-cholesterol from baseline to Week 12 (Part A only)
Change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) at week 12 for Part A and Part B [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) at week 12 for Part A and Part B

Original Secondary Outcome Measures ^ICMJE

Change from baseline in LDL-C at week 12 for Part A and Part B. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in non-high density lipoprotein cholesterol (non-HDL-C) at week 12 for Part A and Part B. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in apolipoprotein B (ApoB) at week 12 for Part A and Part B. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in the total cholesterol/HDL-C ratio at week 12 for Part A and Part B. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in ApoB/apolipoprotein A-1 (ApoA1) ratio at week 12 for Part A and Part B. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Response rate of subjects with 15% or greater reduction in LDL-C from baseline to Week 12 (Part A only). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change from baseline in PCSK9 at week 12 for Part A and Part B. [ 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

Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities

Official Title ^ICMJE

A 2 Part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety, Tolerability, and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia Part B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia

Brief Summary

A study to determine the safety, tolerability, and efficacy of AMG 145 in subjects with homozygous familial hypercholesterolemia.

Detailed Description

Study Masking:

Part A: Open Label Part B: Double Blind

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
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

Homozygous Familial Hypercholesterolemia

Intervention ^ICMJE

Biological: AMG 145
AMG 145 Open Label
Biological: AMG 145
AMG 145
Other: Placebo
Placebo

Study Arm (s)

Active Comparator: Part A: AMG 145
Open Label

Intervention: Biological: AMG 145
Active Comparator: Part B: AMG 145
AMG 145

Intervention: Biological: AMG 145
Placebo Comparator: Part B: 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

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2014

Estimated Primary Completion Date

October 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Males and females ≥ 12 to ≤ 65 years of age
Diagnosis of homozygous familial hypercholesterolemia
Stable lipid-lowering therapies for at least 4 weeks
LDL cholesterol >130 mg/dl (3.4 mmol/L)
Triglyceride < 400 mg/dL(4.5 mmol/L)
Bodyweight of > 40 kg or greater at screening.

Exclusion Criteria:

LDL or plasma apheresis within 8 weeks prior to randomization
New York Heart Failure Association (NYHA) class III or IV or last known left ventricular ejection fraction < 30%
Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months of randomization
Planned cardiac surgery or revascularization
Uncontrolled cardiac arrhythmia
Uncontrolled hypertension

Gender

Both

Ages

12 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Amgen Call Center

866-572-6436

Location Countries ^ICMJE

United States, Belgium, New Zealand, South Africa

Administrative Information

NCT Number ^ICMJE

NCT01588496

Other Study ID Numbers ^ICMJE

20110233

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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