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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01609140




Registration number
NCT01609140
Ethics application status
Date submitted
24/05/2012
Date registered
31/05/2012
Date last updated
2/11/2016

Titles & IDs
Public title
A Phase II Study of the Safety and Efficacy of MPSK3169A in Patients With Coronary Heart Disease or High Risk of Coronary Heart Disease
Scientific title
A Phase II, Randomized, Placebo-Controlled, Double-Blind Study of the Safety and Efficacy of MPSK3169A in Patients With Coronary Heart Disease or High Risk of Coronary Heart Disease
Secondary ID [1] 0 0
GC28210
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Heart Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MPSK3169A
Treatment: Drugs - MPSK3169A
Treatment: Drugs - MPSK3169A
Treatment: Drugs - MPSK3169A
Treatment: Drugs - MPSK3169A
Treatment: Drugs - Placebo

Experimental: A -

Experimental: B -

Experimental: C -

Experimental: D -

Experimental: E -

Placebo Comparator: F -


Treatment: Drugs: MPSK3169A
Dose regimen A, repeating subcutaneous injections every 4 weeks

Treatment: Drugs: MPSK3169A
Dose regimen E, repeating subcutaneous injections every 4 weeks

Treatment: Drugs: MPSK3169A
Dose regimen D, repeating subcutaneous injections every 4 weeks

Treatment: Drugs: MPSK3169A
Dose regimen C, repeating subcutaneous injections every 4 weeks

Treatment: Drugs: MPSK3169A
Dose regimen B, repeating subcutaneous injections every 4 weeks

Treatment: Drugs: Placebo
Repeating subcutaneous injections of placebo every 4 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Absolute change from baseline in LDL-c concentration
Timepoint [1] 0 0
at Day 169
Secondary outcome [1] 0 0
Absolute change from baseline in LDL-c concentration for each arm at the nadir for that arm
Timepoint [1] 0 0
over the 24 week treatment period
Secondary outcome [2] 0 0
Average value over time of the change in LDL-c (absolute and percent change) for each arm, up to Day 169, weighted by the number of weeks between consecutive LDL-c measurements
Timepoint [2] 0 0
up to Day 169
Secondary outcome [3] 0 0
Percent change from baseline in LDL-c concentration at Day 169 and at the nadir for each arm
Timepoint [3] 0 0
at Day 169 and over the 24 week treatment period
Secondary outcome [4] 0 0
Percent and absolute change from baseline in LDL-c concentration at all other designated timepoints
Timepoint [4] 0 0
at all other designated timepoints
Secondary outcome [5] 0 0
Percent and absolute change from baseline in total cholesterol, non-HDL-c, and apolipoprotein B (ApoB) at Day 169 and at the nadir for each arm
Timepoint [5] 0 0
at Day 169 and over the 24 week treatment period

Eligibility
Key inclusion criteria
- Use of a standard-of-care statin at a stable dose, or intolerance of statins, without
use of other lipid modifying therapies

- Fasting LDL cholesterol 90-250 mg/dL on the statin regimen above

And at least one of the following:

- Coronary heart disease (CHD) with a history of myocardial infarction (MI),
percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG),
or prior coronary angiography demonstrating coronary atherosclerosis

- A CHD risk equivalent condition, including diabetes mellitus (type 1 or 2), chronic
kidney disease, prior stroke, carotid disease, peripheral arterial disease, or
abdominal aortic aneurism

- >/=2 CHD risk factors (age >/= 45 years for men or >/= 55 years for women; smoking;
hypertension; low HDL cholesterol; family history of premature CHD) and a high risk of
a CV event based on risk estimation systems
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Severe congestive heart failure (NYHA Class III-IV) or left ventricular ejection
fraction </= 35%

- Recent (within 3 months) MI, unstable angina, stroke, transient ischemic attack, CABG,
PCI, hospital admission for heart failure, major surgery, uncontrolled cardiac
arrhythmia (other than atrial fibrillation or flutter), or initiation of renal
replacement therapy (dialysis)

- Fasting serum triglyceride level >/= 400 mg/dL

- Homozygous familial hypercholesterolemia

- Poorly controlled diabetes mellitus, hypertension or thyroid disease

- Liver or muscle disease, including abnormal test results at screening

- Pregnant or lactating

The above list is not intended to contain all factors relevant to a patient's eligibility
for the study.

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 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
1/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2013
Sample size
Target
Accrual to date
Final
248
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Maine
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
North Dakota
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
South Dakota
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
Canada
State/province [21] 0 0
Newfoundland and Labrador
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
Czech Republic
State/province [24] 0 0
Hodonin
Country [25] 0 0
Czech Republic
State/province [25] 0 0
Jicícin
Country [26] 0 0
Czech Republic
State/province [26] 0 0
Marianske Lazne
Country [27] 0 0
Czech Republic
State/province [27] 0 0
Ostrava - Poruba
Country [28] 0 0
Czech Republic
State/province [28] 0 0
Rakovník
Country [29] 0 0
Germany
State/province [29] 0 0
Berlin
Country [30] 0 0
Germany
State/province [30] 0 0
Köln
Country [31] 0 0
Hungary
State/province [31] 0 0
Komarom
Country [32] 0 0
Hungary
State/province [32] 0 0
Nagykanizsa
Country [33] 0 0
Hungary
State/province [33] 0 0
Nyíregyháza
Country [34] 0 0
Hungary
State/province [34] 0 0
Sopron
Country [35] 0 0
New Zealand
State/province [35] 0 0
Auckland
Country [36] 0 0
New Zealand
State/province [36] 0 0
Christchurch
Country [37] 0 0
New Zealand
State/province [37] 0 0
Nelson
Country [38] 0 0
New Zealand
State/province [38] 0 0
Tauranga
Country [39] 0 0
Norway
State/province [39] 0 0
Elverum
Country [40] 0 0
Norway
State/province [40] 0 0
Hamar
Country [41] 0 0
Norway
State/province [41] 0 0
Oslo
Country [42] 0 0
Norway
State/province [42] 0 0
Sandnes
Country [43] 0 0
Slovakia
State/province [43] 0 0
Bardejov
Country [44] 0 0
Slovakia
State/province [44] 0 0
Bratislava
Country [45] 0 0
Slovakia
State/province [45] 0 0
Presov
Country [46] 0 0
Slovakia
State/province [46] 0 0
Rimavska Sobota
Country [47] 0 0
South Africa
State/province [47] 0 0
Cape Town
Country [48] 0 0
South Africa
State/province [48] 0 0
Centurion
Country [49] 0 0
South Africa
State/province [49] 0 0
Pretoria

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and cholesterol lowering effects of
MPSK3169A when given as subcutaneous (SC) injections over a 24-week period to patients with a
high risk of cardiovascular events and LDL-c levels well above goal.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01609140
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Genentech, Inc.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01609140