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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01763905




Registration number
NCT01763905
Ethics application status
Date submitted
7/01/2013
Date registered
9/01/2013
Date last updated
20/07/2020

Titles & IDs
Public title
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2
Scientific title
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
Secondary ID [1] 0 0
2012-001364-30
Secondary ID [2] 0 0
20110116
Universal Trial Number (UTN)
Trial acronym
GAUSS-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperlipidemia 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Evolocumab
Treatment: Drugs - Placebo to Evolocumab
Treatment: Drugs - Ezetimibe
Treatment: Drugs - Placebo to Ezetimibe

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.

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.

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.

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.


Treatment: Other: Evolocumab
Subcutaneous injection

Treatment: Drugs: Placebo to Evolocumab
Subcutaneous injection

Treatment: Drugs: Ezetimibe
Tablet for oral administration

Treatment: Drugs: Placebo to Ezetimibe
Tablet for oral administration
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline in LDL-C at Week 12
Timepoint [1] 0 0
Baseline and Week 12
Primary outcome [2] 0 0
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Timepoint [2] 0 0
Baseline and Weeks 10 and 12
Secondary outcome [1] 0 0
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Timepoint [1] 0 0
Baseline and Weeks 10 and 12
Secondary outcome [2] 0 0
Change From Baseline in LDL-C at Week 12
Timepoint [2] 0 0
Baseline and Week 12
Secondary outcome [3] 0 0
Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L)
Timepoint [3] 0 0
Weeks 10 and 12
Secondary outcome [4] 0 0
Percentage of Participants With LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12
Timepoint [5] 0 0
Baseline and Weeks 10 and 12
Secondary outcome [6] 0 0
Percent Change From Baseline in Non-HDL-C at Week 12
Timepoint [6] 0 0
Baseline and Week 12
Secondary outcome [7] 0 0
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
Timepoint [7] 0 0
Baseline and Weeks 10 and 12
Secondary outcome [8] 0 0
Percent Change From Baseline in Apolipoprotein B at Week 12
Timepoint [8] 0 0
Baseline and Week 12
Secondary outcome [9] 0 0
Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at the Mean of Weeks 10 and 12
Timepoint [9] 0 0
Baseline and Weeks 10 and 12
Secondary outcome [10] 0 0
Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at Week 12
Timepoint [10] 0 0
Baseline and Week 12
Secondary outcome [11] 0 0
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12
Timepoint [11] 0 0
Baseline and Weeks 10 and 12
Secondary outcome [12] 0 0
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
Timepoint [12] 0 0
Baseline and Week 12
Secondary outcome [13] 0 0
Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12
Timepoint [13] 0 0
Baseline and Weeks 10 and 12
Secondary outcome [14] 0 0
Percent Change From Baseline in Lipoprotein (a) at Week 12
Timepoint [14] 0 0
Baseline and Week 12
Secondary outcome [15] 0 0
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
Timepoint [15] 0 0
Baseline and Weeks 10 and 12
Secondary outcome [16] 0 0
Percent Change From Baseline in Triglycerides at Week 12
Timepoint [16] 0 0
Baseline and Week 12
Secondary outcome [17] 0 0
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12
Timepoint [17] 0 0
Baseline and Weeks 10 and 12
Secondary outcome [18] 0 0
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12
Timepoint [18] 0 0
Baseline and Week 12
Secondary outcome [19] 0 0
Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at the Mean of Weeks 10 and 12
Timepoint [19] 0 0
Baseline and Weeks 10 and 12
Secondary outcome [20] 0 0
Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at Week 12
Timepoint [20] 0 0
Baseline and Week 12

Eligibility
Key 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/11/2013
Sample size
Target
Accrual to date
Final
307
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Milton
Recruitment hospital [3] 0 0
Research Site - Melbourne
Recruitment hospital [4] 0 0
Research Site - Perth
Recruitment postcode(s) [1] 0 0
2015 - Camperdown
Recruitment postcode(s) [2] 0 0
4064 - Milton
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Maine
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
Nevada
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Belgium
State/province [12] 0 0
Brussels
Country [13] 0 0
Belgium
State/province [13] 0 0
Gent
Country [14] 0 0
Belgium
State/province [14] 0 0
La Louvière
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Denmark
State/province [17] 0 0
Aalborg
Country [18] 0 0
Denmark
State/province [18] 0 0
Ballerup
Country [19] 0 0
Denmark
State/province [19] 0 0
Vejle
Country [20] 0 0
France
State/province [20] 0 0
Lille Cedex
Country [21] 0 0
France
State/province [21] 0 0
Paris Cedex 13
Country [22] 0 0
France
State/province [22] 0 0
Vénissieux
Country [23] 0 0
Germany
State/province [23] 0 0
Bad Krozingen
Country [24] 0 0
Germany
State/province [24] 0 0
Dresden
Country [25] 0 0
Germany
State/province [25] 0 0
Heppenheim
Country [26] 0 0
Hong Kong
State/province [26] 0 0
Hong Kong
Country [27] 0 0
Hong Kong
State/province [27] 0 0
New Territories
Country [28] 0 0
Netherlands
State/province [28] 0 0
Alkmaar
Country [29] 0 0
Netherlands
State/province [29] 0 0
Amsterdam
Country [30] 0 0
Netherlands
State/province [30] 0 0
Groningen
Country [31] 0 0
Poland
State/province [31] 0 0
Lodz
Country [32] 0 0
Poland
State/province [32] 0 0
Warszawa
Country [33] 0 0
South Africa
State/province [33] 0 0
Gauteng
Country [34] 0 0
South Africa
State/province [34] 0 0
Western Cape
Country [35] 0 0
Spain
State/province [35] 0 0
Andalucía
Country [36] 0 0
Spain
State/province [36] 0 0
Aragón
Country [37] 0 0
Spain
State/province [37] 0 0
Cataluña
Country [38] 0 0
Switzerland
State/province [38] 0 0
Lugano
Country [39] 0 0
Switzerland
State/province [39] 0 0
Reinach
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Liverpool
Country [41] 0 0
United Kingdom
State/province [41] 0 0
London
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Telford
Country [43] 0 0
United Kingdom
State/province [43] 0 0
West Bromwich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01763905