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

• Register: EUCTR
• Last refreshed on: 9 September 2013
• Main ID: EUCTR2012-000191-41-HU
• Date of registration: 02/05/2012
• Prospective Registration: Yes
• Primary sponsor: GENENTECH, Inc.
• Public 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
• 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
• Date of first enrolment: 19/06/2012
• Target sample size: 224
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000191-41
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 6

Countries of recruitment

Canada, Czech Republic, Germany, Hungary, New Zealand, Norway, Slovakia, South Africa, United States

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: Genentech Inc. C/O F. Hoffmann-La Roche Ltd.

• Name: Trial Information Support Line-TISL
• Affiliation: Genentech Inc. C/O F. Hoffmann-La Roche Ltd.

Key inclusion & exclusion criteria

Inclusion criteria:
• 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 =45y for men or =55y 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
• 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 134
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Coronary Heart Disease or High Risk of Coronary Heart Disease
MedDRA version: 14.1 Level: LLT Classification code 10068617 Term: Coronary heart disease System Organ Class: 10007541 - Cardiac disorders

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Intervention(s)

Product Code: MPSK3169A (RO6801831)
Pharmaceutical Form: Solution for injection
Current Sponsor code: MPSK3169A (RO6801831)
Other descriptive name: PRO352730
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: • To evaluate the safety of MPSK3169A on top of standard-of-care (SOC) statin in patients with an low-density lipoprotein cholesterol (LDL-c) of 90-250 mg/dL and either coronary heart disease (CHD) or a CHD risk equivalent
• To evaluate the ability of MPSK3169A to reduce LDL-c on top of SOC statin therapy in patients with an LDL-c of 90-250 mg/dL and either CHD or a CHD risk equivalent

Secondary Objective: The PK and PD objectives for this study are as follows:
• To characterize the serum concentration of MPSK3169A over time following multiple subcutaneous (SC) doses of MPSK3169A
• To evaluate the effect of MPSK3169A on LDL-c–related biomarkers
• To characterize the relationship between MPSK3169A concentration and the effect on LDL-c and LDL-c–related biomarkers

Primary end point(s): Absolute change from baseline in LDL-c concentration at Day 169

Timepoint(s) of evaluation of this end point: Day 169

Secondary Outcome(s)

Secondary end point(s): 1. Absolute change from baseline in LDL-c concentration for each arm at the nadir for that arm
2. 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
3. Percent change from baseline in LDL-c concentration at Day 169 and at the nadir for each arm
4. Percent and absolute change from baseline in LDL-c concentration at all other designated timepoints
5. 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(s) of evaluation of this end point: 1. at the nadir for that arm
2. up to Day 169,
3. at Day 169 and at the nadir for each arm
4. at all other designated timepoints
5. at Day 169 and at the nadir for each arm

Secondary ID(s)

GC28210

Source(s) of Monetary Support

Genentech Inc. C/O F. Hoffmann-La Roche Ltd.