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 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Coronary Heart Disease
Drug: MPSK3169A
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Absolute change from baseline in LDL-c concentration [ Time Frame: at Day 169 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 248
Study Start Date: May 2012
Study Completion Date: July 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: MPSK3169A
Dose regimen A, repeating subcutaneous injections every 4 weeks
Experimental: B Drug: MPSK3169A
Dose regimen B, repeating subcutaneous injections every 4 weeks
Experimental: C Drug: MPSK3169A
Dose regimen C, repeating subcutaneous injections every 4 weeks
Experimental: D Drug: MPSK3169A
Dose regimen D, repeating subcutaneous injections every 4 weeks
Experimental: E Drug: MPSK3169A
Dose regimen E, repeating subcutaneous injections every 4 weeks
Placebo Comparator: F Drug: Placebo
Repeating subcutaneous injections of placebo every 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609140

  Show 73 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01609140     History of Changes
Other Study ID Numbers: GC28210
Study First Received: May 24, 2012
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Hyperlipidemia
Dyslipidemia

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014