January 7, 2013
|
January 9, 2013
|
September 2, 2015
|
December 22, 2015
|
December 22, 2015
|
January 2013
|
November 2013 (Final data collection date for primary outcome measure)
|
- Percent Change From Baseline in LDL-C at Week 12 [ Time Frame: Baseline and Week 12 ]
- Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ]
|
|
Complete list of historical versions of study NCT01763905 on ClinicalTrials.gov Archive Site
|
- Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ]
- Change From Baseline in LDL-C at Week 12 [ Time Frame: Baseline and Week 12 ]
- Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L) [ Time Frame: Weeks 10 and 12 ]
- Percentage of Participants With LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12 [ Time Frame: Week 12 ]
- Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ]
- Percent Change From Baseline in Non-HDL-C at Week 12 [ Time Frame: Baseline and Week 12 ]
- Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ]
- Percent Change From Baseline in Apolipoprotein B at Week 12 [ Time Frame: Baseline and Week 12 ]
- Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ]
- Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at Week 12 [ Time Frame: Baseline and Week 12 ]
- Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ]
- Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 [ Time Frame: Baseline and Week 12 ]
- Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ]
- Percent Change From Baseline in Lipoprotein (a) at Week 12 [ Time Frame: Baseline and Week 12 ]
- Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ]
- Percent Change From Baseline in Triglycerides at Week 12 [ Time Frame: Baseline and Week 12 ]
- Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ]
- Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ]
- Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ]
- Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at Week 12 [ Time Frame: Baseline and Week 12 ]
|
- Mean change from baseline in low density lipoprotein-cholesterol [ Time Frame: 10 and 12 Weeks ]
Mean change from baseline in low density lipoprotein-cholesterol
- Change from baseline in low density lipoprotein-cholesterol [ Time Frame: 12 Weeks ]
Change from baseline in low density lipoprotein-cholesterol
- Mean Low Density Lipoprotein-Cholesterol response (LDL-C < 70 mg/dL [1.8 mmol/L]) [ Time Frame: 10 and 12 Weeks ]
Mean Low Density Lipoprotein-Cholesterol response (LDL-C < 70 mg/dL [1.8 mmol/L])
- Low Density Lipoprotein-Cholesterol response (LDL-C < 70 mg/dL [1.8 mmol/L]) [ Time Frame: 12 Weeks ]
Low Density Lipoprotein-Cholesterol response (LDL-C < 70 mg/dL [1.8 mmol/L])
- Mean percent change from baseline in non-high density lipoprotein-cholesterol [ Time Frame: 10 and 12 Weeks ]
Mean percent change from baseline in non-high density lipoprotein-cholesterol
- Percent change from baseline in non-high density lipoprotein-cholesterol [ Time Frame: 12 Weeks ]
Percent change from baseline in non-high density lipoprotein-cholesterol
- Mean percent change from baseline in apolipoprotein B [ Time Frame: 10 and 12 Weeks ]
Mean percent change from baseline in apolipoprotein B
- Percent change from baseline in apolipoprotein B [ Time Frame: 12 Weeks ]
Percent change from baseline in apolipoprotein B
- Mean percent change from baseline in the total cholesterol/high density lipoprotein-cholesterol ratio [ Time Frame: 10 and 12 Weeks ]
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: 12 Weeks ]
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: 10 and 12 Weeks ]
Mean percent change from baseline in apolipoprotein B/apolipoprotein A1 ratio
- Percent change from baseline in apolipoprotein B/apolipoprotein A1 ratio [ Time Frame: 12 Weeks ]
Percent change from baseline in apolipoprotein B/apolipoprotein A1 ratio
- Mean percent change from baseline in lipoprotein (a) [ Time Frame: 10 and 12 Weeks ]
Mean percent change from baseline in lipoprotein (a)
- Percent change from baseline in lipoprotein (a) [ Time Frame: 12 Weeks ]
Percent change from baseline in lipoprotein (a)
- Mean percent change from baseline in triglycerides [ Time Frame: 10 and 12 Weeks ]
Mean percent change from baseline in triglycerides
- Percent change from baseline in triglycerides [ Time Frame: 12 Weeks ]
Percent change from baseline in triglycerides
- Mean percent change from baseline in high density lipoprotein-cholesterol [ Time Frame: 10 and 12 Weeks ]
Mean percent change from baseline in high density lipoprotein-cholesterol
- Percent change from baseline in high density lipoprotein-cholesterol [ Time Frame: 12 Weeks ]
Percent change from baseline in high density lipoprotein-cholesterol
- Mean percent change from baseline in very low density lipoprotein-cholesterol [ Time Frame: 10 and 12 Weeks ]
Mean percent change from baseline in very low density lipoprotein-cholesterol
- Percent change from baseline in very low density lipoprotein-cholesterol [ Time Frame: 12 Weeks ]
Percent change from baseline in very low density lipoprotein-cholesterol
|
Not Provided
|
Not Provided
|
|
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2 |
A Double-blind, Randomized, Multicenter Study to Evaluate Safety and Efficacy of AMG 145, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor |
The primary objective was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable to tolerate an effective dose of a statin (HMG-CoA (5-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors). |
Not Provided |
Interventional |
Phase 3 |
Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Hyperlipidemia |
|
- Active Comparator: Ezetimibe (Q2W)
Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
Interventions:
- Drug: Placebo to Evolocumab
- Drug: Ezetimibe
- Active Comparator: Ezetimibe (QM)
Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
Interventions:
- Drug: Placebo to Evolocumab
- Drug: Ezetimibe
- Experimental: Evolocumab Q2W
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
Interventions:
- Biological: Evolocumab
- Drug: Placebo to Ezetimibe
- Experimental: Evolocumab QM
Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
Interventions:
- Biological: Evolocumab
- Drug: Placebo to Ezetimibe
|
- Cho L, Rocco M, Colquhoun D, Sullivan D, Rosenson RS, Dent R, Xue A, Scott R, Wasserman SM, Stroes E. Design and rationale of the GAUSS-2 study trial: a double-blind, ezetimibe-controlled phase 3 study of the efficacy and tolerability of evolocumab (AMG 145) in subjects with hypercholesterolemia who are intolerant of statin therapy. Clin Cardiol. 2014 Mar;37(3):131-9. doi: 10.1002/clc.22248. Epub 2014 Jan 29.
- Stroes E, Colquhoun D, Sullivan D, Civeira F, Rosenson RS, Watts GF, Bruckert E, Cho L, Dent R, Knusel B, Xue A, Scott R, Wasserman SM, Rocco M; GAUSS-2 Investigators. Anti-PCSK9 antibody effectively lowers cholesterol in patients with statin intolerance: the GAUSS-2 randomized, placebo-controlled phase 3 clinical trial of evolocumab. J Am Coll Cardiol. 2014 Jun 17;63(23):2541-2548. doi: 10.1016/j.jacc.2014.03.019. Epub 2014 Mar 30.
|
|
Completed |
307 |
300 |
November 2013 |
November 2013 (Final data collection date for primary outcome measure) |
Inclusion Criteria:
- Male or female ≥ 18 to ≤ 80 years of age
- Not on a statin or on a low dose statin with stable dose for at least 4 weeks
- History of intolerance to at least 2 statins
- Subject not at LDL-C goal
- Lipid lowering therapy has been stable prior to enrolment for at least 4 weeks.
- Fasting triglycerides ≤ 400 mg/dL
Exclusion Criteria:
- New York Heart Association (NYHA) III or IV heart failure
- Uncontrolled cardiac arrhythmia
- Uncontrolled hypertension
- Type 1 diabetes, poorly controlled type 2 diabetes
- Uncontrolled hypothyroidism or hyperthyroidism
|
Sexes Eligible for Study: |
All |
|
18 Years to 80 Years (Adult, Senior) |
No |
Contact information is only displayed when the study is recruiting subjects |
Australia, Belgium, Canada, Denmark, France, Germany, Hong Kong, Netherlands, Poland, South Africa, Spain, Switzerland, United Kingdom, United States |
|
|
NCT01763905 |
20110116 2012-001364-30 ( EudraCT Number ) |
Yes |
Not Provided |
Not Provided |
Amgen |
Amgen |
Not Provided |
|
Amgen |
November 2015 |