Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01984424
First received: November 8, 2013
Last updated: July 16, 2014
Last verified: July 2014

November 8, 2013
July 16, 2014
December 2013
October 2017   (final data collection date for primary outcome measure)
  • Mean percent change from baseline in low density lipoprotein-cholesterol [ Time Frame: 22 and 24 Weeks ] [ Designated as safety issue: No ]
    Mean percent change from baseline in low density lipoprotein-cholesterol
  • Percent change from baseline in low density lipoprotein-cholesterol [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in low density lipoprotein-cholesterol
Same as current
Complete list of historical versions of study NCT01984424 on ClinicalTrials.gov Archive Site
  • Mean change from baseline in low density lipoprotein-cholesterol [ Time Frame: 22 and 24 Weeks ] [ Designated as safety issue: No ]
    Mean change from baseline in low density lipoprotein-cholesterol
  • Change from baseline in low density lipoprotein-cholesterol [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    Change from baseline in low density lipoprotein-cholesterol
  • Mean low density lipoprotein-cholesterol response (low density lipoprotein-cholesterol < 70 mg/dL [1.8 mmol/L]) [ Time Frame: 22 and 24 Weeks ] [ Designated as safety issue: No ]
    Mean low density lipoprotein-cholesterol response (low density lipoprotein-cholesterol < 70 mg/dL [1.8 mmol/L])
  • Low density lipoprotein-cholesterol response (low density lipoprotein-cholesterol < 70 mg/dL [1.8 mmol/L]) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    Low density lipoprotein-cholesterol response (low density lipoprotein-cholesterol < 70 mg/dL [1.8 mmol/L])
  • Mean percent change from baseline in total cholesterol [ Time Frame: 22 and 24 Weeks ] [ Designated as safety issue: No ]
    Mean percent change from baseline in total cholesterol
  • Percent change from baseline in total cholesterol [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in total cholesterol
  • Mean percent change from baseline in non-high density lipoprotein-cholesterol [ Time Frame: 22 and 24 Weeks ] [ Designated as safety issue: No ]
    Mean percent change from baseline in non-high density lipoprotein-cholesterol
  • Percent change from baseline in non-high density lipoprotein-cholesterol [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in non-high density lipoprotein-cholesterol
  • Mean percent change from baseline in apolipoprotein B [ Time Frame: 22 and 24 Weeks ] [ Designated as safety issue: No ]
    Mean percent change from baseline in apolipoprotein B
  • Percent change from baseline in apolipoprotein B [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in apolipoprotein B
  • Mean percent change from baseline in the total cholesterol/high density lipoprotein-cholesterol ratio [ Time Frame: 22 and 24 Weeks ] [ Designated as safety issue: No ]
    Mean percent change from baseline in the total cholesterol/high density lipoprotein-cholesterol ratio
  • Percent change from baseline in the total cholesterol/high density lipoprotein-cholesterol ratio [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in the total cholesterol/high density lipoprotein-cholesterol ratio
  • Mean percent change from baseline in apolipoprotein B/apolipoprotein A1 ratio [ Time Frame: 22 and 24 Weeks ] [ Designated as safety issue: No ]
    Mean percent change from baseline in apolipoprotein B/apolipoprotein A1 ratio
  • Percent change from baseline in apolipoprotein B/apolipoprotein A1 ratio [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in apolipoprotein B/apolipoprotein A1 ratio
  • Mean percent change from baseline in lipoprotein (a) [ Time Frame: 22 and 24 Weeks ] [ Designated as safety issue: No ]
    Mean percent change from baseline in lipoprotein (a)
  • Percent change from baseline in lipoprotein (a) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in lipoprotein (a)
  • Mean percent change from baseline in triglycerides [ Time Frame: 22 and 24 Weeks ] [ Designated as safety issue: No ]
    Mean percent change from baseline in triglycerides
  • Percent change from baseline in triglycerides [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in triglycerides
  • Mean percent change from baseline in high density lipoprotein-cholesterol [ Time Frame: 22 and 24 Weeks ] [ Designated as safety issue: No ]
    Mean percent change from baseline in high density lipoprotein-cholesterol
  • Percent change from baseline in high density lipoprotein-cholesterol [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in high density lipoprotein-cholesterol
  • Mean percent change from baseline in very low density lipoprotein-cholesterol [ Time Frame: 22 and 24 Weeks ] [ Designated as safety issue: No ]
    Mean percent change from baseline in very low density lipoprotein-cholesterol
  • Percent change from baseline in very low density lipoprotein-cholesterol [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in very low density lipoprotein-cholesterol
Same as current
Not Provided
Not Provided
 
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3
A Double-blind, Randomized, Multicenter Study to Evaluate the Safety and Efficacy of Evolocumab, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor Due to Muscle Related Side Effects

The study is divided into 3 parts (A, B, C). Part A is a double-blind, placebo-controlled, two-period cross-over rechallenge of atorvastatin 20 mg. Part B is a 24-week double-blind, double-dummy comparison of evolocumab and ezetimibe. Part C is a 2-year open-label evolocumab extension. The primary hypothesis is that evolocumab will be well tolerated and will result in greater reduction of LDL-C than ezetimibe, defined by the mean percent change from baseline at Weeks 22 and 24 of Part B and percent change from baseline at Week 24 of Part B, in statin-intolerant hypercholesterolemic subjects.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hyperlipidemia
  • Drug: Part A, Atorvastatin
    Subjects will receive atorvastatin daily
  • Other: Part A, Placebo (administered orally)
    Subjects will receive oral placebo daily
  • Drug: Part B, Evolocumab
    Subjects will receive subcutaneous evolocumab every month
  • Other: Part B, Placebo (administered orally)
    Subjects will receive oral placebo every day
  • Drug: Part B, Ezetimibe
    Subjects will receive oral ezetimibe daily
  • Other: Part B, Placebo (administered subcutaneously)
    Subjects will receive subcutaneous placebo every month.
  • Drug: Part C, Evolocumab
    Subjects will receive subcutaneous evolocumab every 2 weeks or monthly
  • Experimental: Part A (two-period cross-over), Arm 1
    Atorvastatin
    Interventions:
    • Drug: Part A, Atorvastatin
    • Other: Part A, Placebo (administered orally)
  • Placebo Comparator: Part A (two-period cross-over), Arm 2
    Placebo
    Interventions:
    • Drug: Part A, Atorvastatin
    • Other: Part A, Placebo (administered orally)
  • Experimental: Part B, Arm 1
    Evolocumab
    Interventions:
    • Drug: Part B, Evolocumab
    • Other: Part B, Placebo (administered orally)
  • Active Comparator: Part B, Arm 2
    Ezetimbe
    Interventions:
    • Drug: Part B, Ezetimibe
    • Other: Part B, Placebo (administered subcutaneously)
  • Experimental: Part C, Arm 1
    Evolocumab
    Intervention: Drug: Part C, Evolocumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
April 2018
October 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female ≥ 18 to ≤ 80 years of age
  • Subject not at LDL-C goal
  • History of statin intolerance
  • Lipid lowering therapy has been stable prior to enrolment for at least 4 weeks
  • Fasting triglycerides ≤ 400 mg/dL

Exclusion Criteria:

  • NYHA III or IV heart failure
  • Uncontrolled cardiac arrhythmia
  • Uncontrolled hypertension
  • Type 1 diabetes
  • Poorly controlled type 2 diabetes
  • Uncontrolled hypothyroidism or hyperthyroidism
Both
18 Years to 80 Years
No
Contact: Amgen Call Center 866-572-6436
United States,   Australia,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Italy,   Netherlands,   Norway,   South Africa,   United Kingdom
 
NCT01984424
20120332
Yes
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
July 2014

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