Trial record 17 of 103 for:
Open Studies | "Hypercholesterolemia"
Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities (TESLA)
This study is currently recruiting participants.
Verified May 2013 by Amgen
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01588496
First received: February 27, 2012
Last updated: May 6, 2013
Last verified: May 2013
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Purpose
A study to determine the safety, tolerability, and efficacy of AMG 145 in subjects with homozygous familial hypercholesterolemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Homozygous Familial Hypercholesterolemia |
Biological: AMG 145 Other: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Chanarin-Dorfman syndrome
cholesteryl ester storage disease
Farber lipogranulomatosis
hypercholesterolemia
MedlinePlus related topics:
Cholesterol
U.S. FDA Resources
Further study details as provided by Amgen:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 67 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Part A: AMG 145
Open Label
|
Biological: AMG 145
AMG 145 Open Label
|
|
Active Comparator: Part B: AMG 145
AMG 145
|
Biological: AMG 145
AMG 145
|
|
Placebo Comparator: Part B: Placebo
Placebo
|
Other: Placebo
Placebo
|
Detailed Description:
Study Masking:
Part A: Open Label Part B: Double Blind
Eligibility| Ages Eligible for Study: | 12 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588496
Contacts
| Contact: Amgen Call Center | 866-572-6436 |
Locations
| United States, Ohio | |
| Research Site | Recruiting |
| Cincinnati, Ohio, United States, 45227 | |
| Belgium | |
| Research Site | Recruiting |
| Bruxelles, Belgium, 1200 | |
| New Zealand | |
| Research Site | Recruiting |
| Christchurch, New Zealand, 8011 | |
| South Africa | |
| Research Site | Recruiting |
| Johannesburg, Gauteng, South Africa, 2193 | |
| Research Site | Recruiting |
| Observatory, Western Cape, South Africa, 7925 | |
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01588496 History of Changes |
| Other Study ID Numbers: | 20110233 |
| Study First Received: | February 27, 2012 |
| Last Updated: | May 6, 2013 |
| Health Authority: | South Africa: Medicines Control Council Belgium: Federal Agency for Medicinal Products and Health Products Canada: Health Canada United States: Food and Drug Administration New Zealand: Medsafe |
Keywords provided by Amgen:
|
hypercholesterolemia familial hypercholesterolemia homozygous familial hypercholesterolemia |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipoproteinemia Type II Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders |
Metabolic Diseases Lipid Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Hyperlipoproteinemias |
ClinicalTrials.gov processed this record on May 23, 2013