A Phase II Study of the Safety and Efficacy of MPSK3169A in Patients With Coronary Heart Disease or High Risk of Coronary Heart Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01609140
First received: May 24, 2012
Last updated: July 7, 2014
Last verified: July 2014

May 24, 2012
July 7, 2014
May 2012
May 2013   (final data collection date for primary outcome measure)
Absolute change from baseline in LDL-c concentration [ Time Frame: at Day 169 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01609140 on ClinicalTrials.gov Archive Site
  • Absolute change from baseline in LDL-c concentration for each arm at the nadir for that arm [ Time Frame: over the 24 week treatment period ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: up to Day 169 ] [ Designated as safety issue: No ]
  • Percent change from baseline in LDL-c concentration at Day 169 and at the nadir for each arm [ Time Frame: at Day 169 and over the 24 week treatment period ] [ Designated as safety issue: No ]
  • Percent and absolute change from baseline in LDL-c concentration at all other designated timepoints [ Time Frame: at all other designated timepoints ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: at Day 169 and over the 24 week treatment period ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Phase II Study of the Safety and Efficacy of MPSK3169A in Patients With Coronary Heart Disease or High Risk of Coronary Heart Disease
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

The purpose of this study is to evaluate the safety and cholesterol lowering eff ects of MPSK3169A when given as subcutaneous (SC) injections over a 24-week peri od to patients with a high risk of cardiovascular events and LDL-c levels well a bove goal.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Coronary Heart Disease
  • Drug: MPSK3169A
    Dose regimen A, repeating subcutaneous injections every 4 weeks
  • Drug: Placebo
    Repeating subcutaneous injections of placebo every 4 weeks
  • Drug: MPSK3169A
    Dose regimen B, repeating subcutaneous injections every 4 weeks
  • Drug: MPSK3169A
    Dose regimen C, repeating subcutaneous injections every 4 weeks
  • Drug: MPSK3169A
    Dose regimen D, repeating subcutaneous injections every 4 weeks
  • Drug: MPSK3169A
    Dose regimen E, repeating subcutaneous injections every 4 weeks
  • Experimental: A
    Intervention: Drug: MPSK3169A
  • Experimental: B
    Intervention: Drug: MPSK3169A
  • Experimental: C
    Intervention: Drug: MPSK3169A
  • Experimental: D
    Intervention: Drug: MPSK3169A
  • Experimental: E
    Intervention: Drug: MPSK3169A
  • Placebo Comparator: F
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
248
July 2013
May 2013   (final data collection date for primary outcome measure)

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

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.

Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Czech Republic,   Germany,   Hungary,   New Zealand,   Norway,   Slovakia,   South Africa
 
NCT01609140
GC28210
Not Provided
Genentech
Genentech
Not Provided
Study Director: Clinical Trials Genentech
Genentech
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP