Trial record 1 of 1 for:    20120153
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GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound (GLAGOV)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01813422
First received: March 15, 2013
Last updated: October 9, 2014
Last verified: October 2014
  Purpose

This study will evaluate whether low-density lipoprotein (LDL-C) lowering with Evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in subjects with coronary artery disease taking lipid lowering therapy.


Condition Intervention Phase
Hypercholesterolemia
Biological: Evolocumab (AMG 145)
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Multi-center, Placebo-controlled, Parallel-group Study to Determine the Effects of Evolocumab (AMG 145) Treatment on Atherosclerotic Disease Burden as Measured by Intravascular Ultrasound in Subjects Undergoing Coronary Catheterization.

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Nominal change in PAV from baseline to week 78 post randomization, as determined by intravascular ultrasound (IVUS) [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Regression (any reduction from baseline) in PAV [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • Nominal change in total atheroma volume (TAV) from baseline to week 78 [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • Regression (any reduction from baseline) in TAV [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 950
Study Start Date: May 2013
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Evolocumab (AMG 145)
Evolocumab (AMG 145)
Biological: Evolocumab (AMG 145)
Subjects randomized to the Evolocumab (AMG 145) arm will receive Evolocumab (AMG 145) subcutaneously every 4 weeks
Placebo Comparator: Placebo
Placebo
Other: Placebo
Subjects randomized to the placebo arm will receive Placebo subcutaneously every 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female ≥ 18 years of age
  • Clinical indication for coronary angiography
  • Subjects already taking statin therapy, niacin or ezetimibe at screening must have been on a stable dose for at least 4 weeks prior to screening LDL-C. Subjects not taking lipid-regulating therapy must enter the study via a lipid stabilization period. Subjects who are intolerant to statins must meet statin intolerance entry criteria
  • Fasting LDL-C ≥ 80 mg/dL (2.07 mmol/L) with or without additional risk factors, or, LDL-C ≥ 60 -<80 mg/dL (1.55-2.07 mmol/L) in the presence of one major or three minor risk factors as defined below.

Major Risk Factors (1 required):

  1. Non coronary atherosclerotic vascular disease (documented peripheral arterial disease (PAD), abdominal aortic aneurysm (AAA) or cerebrovascular disease (CD)).
  2. Documented history of myocardial infarction or hospitalization for unstable angina within the last 2 years
  3. Documented Type 2 diabetes mellitus Minor Risk factors (three required): Current cigarette smoker, Hypertension, Low HDL cholesterol, Family history of premature CHD, age or hs-CRP ≥ 2 mg/dL

Subjects must meet the following criteria at the qualifying coronary catheterization procedure:

  • Evidence of coronary heart disease (at least one lesion in a native coronary artery that has >20% reduction in lumen diameter) or prior PCI
  • Left main coronary artery <50% reduction in lumen diameter by visual estimation
  • Target Coronary Artery for IVUS must be accessible to the IVUS catheter, must not have a >50% reduction in lumen diameter within the target segment (and at least 40mm in length); cannot have undergone prior PCI or CABG and is not a candidate for intervention over the next 18 months. It may not be a bypass graft, bypassed vessel or culprit vessel for previous MI.

Exclusion Criteria:

  • Clinically significant heart disease likely to require intervention during the course of the study
  • Coronary artery bypass graft surgery < 6 weeks prior to the qualifying IVUS
  • NYHA III or IV heart failure, or last known left ventricular ejection fraction less than 30%
  • Uncontrolled cardiac arrhythmia
  • Known hemorrhagic stroke
  • Uncontrolled hypertension at randomization
  • Personal or family history of hereditary muscular disorders
  • Fasting TGs ≥ 400 mg/dL (4.5 mmol/L) at screening
  • Subject has taken a CETP inhibitor in the last 12 months prior to LDL-C screening.
  • Type 1 diabetes or poorly controlled type 2 diabetes (HbA1c > 9%)
  • Treatment for more than 2 weeks in the last 3 months prior to LDL-C screening with systemic cyclosporine/steroids/vitamin A or retinol derivatives for the treatment of dermatologic conditions
  • Thyroid stimulating hormone (TSH) < lower limit of normal or > 1.5x upper limit of normal (unless below LLN, treated and in clinically euthyroid state)
  • Moderate to severe renal dysfunction
  • Active liver disease or hepatic dysfunction
  • CK > 3 times the ULN at screening or at end of lipid stabilization period
  • Known active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction
  • Baseline IVUS does not meet IVUS Core Lab technical standards
  • Unreliability as a study participant
  • Currently enrolled in or < 30 days since ending another investigational device / drug study
  • Female subject who has not used an acceptable method(s) of birth control for at least 1 month prior to screening, or who is not willing to inform her partner or her participation in the study, unless the female subject is sterilized or postmenopausal
  • Subject is pregnant or breast feeding, planning to become pregnant, or planning to breastfeed during the study
  • History of malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma)
  • Subject has previously received AMG 145 or any other investigational therapy to inhibit PCSK9
  • Known sensitivity to any of the active substances or their excipients
  • Subject will not be available for protocol-required study visits or procedures
  • Subject is not suitable in the opinion of the investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01813422

Contacts
Contact: Amgen Call Center 866-572-6436

  Show 224 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01813422     History of Changes
Other Study ID Numbers: 20120153
Study First Received: March 15, 2013
Last Updated: October 9, 2014
Health Authority: Argentina: AMAT (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica)
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: ANVISA (Agencia Nacional de Vigilancia Sanitária)
Canada: Health Canada
Chile: Instituto de Salud Publica
Czech Republic: State Institute for Drug Control
Denmark: Danish Health and Medicines Authority (Sundhedsstyrelsen)
Finland: Finnish Medicines Agency (Fimea)
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Greece: National Drug Organization (NOF)
Hungary: National Institute of Pharmacy
Iceland: Icelandic Medicines Agency (Lyfjastofnun)
Ireland: Irish Medicines Board
Israel: Ministry of Health
Italy: Ministry of Health
Malaysia: Ministry of Health
Mexico: Federal Commission for Sanitary Risks Protection
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency (Statens legemiddelverk)
Philippines : Food and Drug Administration
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Switzerland: Swissmedic
Taiwan: Taiwan Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Amgen:
Cholesterol
High Cholesterol
Elevated Cholesterol
Raised Cholesterol

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 29, 2014