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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01375764




Registration number
NCT01375764
Ethics application status
Date submitted
16/06/2011
Date registered
17/06/2011
Date last updated
7/11/2022

Titles & IDs
Public title
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects
Scientific title
A Randomized, Multicenter Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor
Secondary ID [1] 0 0
20090159
Universal Trial Number (UTN)
Trial acronym
GAUSS
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 - Ezetimibe
Other interventions - Placebo to Evolocumab

Active comparator: Ezetimibe - Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.

Experimental: Evolocumab + Ezetimibe - Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.

Experimental: Evolocumab 280 mg - Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Experimental: Evolocumab 350 mg - Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Experimental: Evolocumab 420 mg - Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.


Treatment: Other: Evolocumab
Administered by subcutaneous injection

Treatment: Drugs: Ezetimibe
Administered orally once a day

Other interventions: Placebo to Evolocumab
Administered by subcutaneous injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (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 Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
Timepoint [2] 0 0
Baseline and Week 12
Secondary outcome [1] 0 0
Change From Baseline in LDL-C at Week 12
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [2] 0 0
Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
Timepoint [2] 0 0
Baseline and Week 12
Secondary outcome [3] 0 0
Percent Change From Baseline in Non-HDL-C at Week 12
Timepoint [3] 0 0
Baseline and Week 12
Secondary outcome [4] 0 0
Percent Change From Baseline in Non-HDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
Timepoint [4] 0 0
Baseline and Week 12
Secondary outcome [5] 0 0
Percent Change From Baseline in Apolipoprotein B at Week 12
Timepoint [5] 0 0
Baseline and Week 12
Secondary outcome [6] 0 0
Percent Change From Baseline in Apolipoprotein B at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
Timepoint [6] 0 0
Baseline and Week 12
Secondary outcome [7] 0 0
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12
Timepoint [7] 0 0
Baseline and Week 12
Secondary outcome [8] 0 0
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
Timepoint [8] 0 0
Baseline and Week 12
Secondary outcome [9] 0 0
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
Timepoint [9] 0 0
Baseline and Week 12
Secondary outcome [10] 0 0
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
Timepoint [10] 0 0
Baseline and Week 12

Eligibility
Key inclusion criteria
* Male or female = 18 to = 75 years of age
* On a statin or a low dose statin with stable dose for at least 4 weeks
* Lipid lowering therapy has been stable prior to enrollment
* Fasting triglycerides must be < 400 mg/dL.
* Subject not at LDL-C goal
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* New York Heart Association (NYHA) III or IV heart failure or known left ventricular ejection fraction < 30%
* Uncontrolled cardiac arrhythmia
* Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization
* Type 1 diabetes or newly diagnosed type 2 diabetes (HbA1c > 8.5%)
* Uncontrolled hypertension

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 2
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
28/07/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/05/2012
Sample size
Target
Accrual to date
Final
160
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Sydney
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
2022 - Sydney
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
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Montana
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
Tennessee
Country [11] 0 0
Belgium
State/province [11] 0 0
Bruxelles
Country [12] 0 0
Belgium
State/province [12] 0 0
Uccle
Country [13] 0 0
Canada
State/province [13] 0 0
Newfoundland and Labrador
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
Denmark
State/province [15] 0 0
Ballerup
Country [16] 0 0
Denmark
State/province [16] 0 0
Vejle
Country [17] 0 0
Finland
State/province [17] 0 0
Helsinki
Country [18] 0 0
Finland
State/province [18] 0 0
OYS
Country [19] 0 0
Spain
State/province [19] 0 0
Aragón
Country [20] 0 0
Spain
State/province [20] 0 0
Aragón
Country [21] 0 0
Spain
State/province [21] 0 0
Cataluña
Country [22] 0 0
Spain
State/province [22] 0 0
Cataluña
Country [23] 0 0
Sweden
State/province [23] 0 0
Göteborg
Country [24] 0 0
Sweden
State/province [24] 0 0
Göteborg
Country [25] 0 0
Sweden
State/province [25] 0 0
Lund
Country [26] 0 0
Sweden
State/province [26] 0 0
Stockholm

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/NCT01375764