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

  Hide Study Locations
Locations
United States, Arizona
Goodyear, Arizona, United States, 85395
United States, California
Carmichael, California, United States, 95608
Spring Valley, California, United States, 91978
Walnut Creek, California, United States, 94598
Wildomar, California, United States, 92595
United States, Florida
Jacksonville, Florida, United States, 32216
Ponte Verde, Florida, United States, 32081
United States, Idaho
Boise, Idaho, United States, 83704
United States, Indiana
Indianapolis, Indiana, United States, 46260
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Maine
Auburn, Maine, United States, 04210
United States, Maryland
Baltimore, Maryland, United States, 21209
Bethesda, Maryland, United States, 20817
United States, Missouri
St. Louis, Missouri, United States, 63110
United States, New York
Rochester, New York, United States, 14609
United States, North Carolina
Wilmington, North Carolina, United States, 28401
United States, North Dakota
Fargo, North Dakota, United States, 58103
United States, Ohio
Cincinnati, Ohio, United States, 45219
Cincinnati, Ohio, United States, 45212
Springdale, Ohio, United States, 45246
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73103
Tulsa, Oklahoma, United States, 74136
United States, South Carolina
Greer, South Carolina, United States, 29650
Mount Pleasant, South Carolina, United States, 29464
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Bristol, Tennessee, United States, 37620
Knoxville, Tennessee, United States, 27912
United States, Texas
Boerne, Texas, United States, 78006
Dallas, Texas, United States, 75230
Dallas, Texas, United States, 75231
Houston, Texas, United States, 77030
United States, Virginia
Richmond, Virginia, United States, 23294
United States, Washington
Wenatchee, Washington, United States, 98801
Canada, Newfoundland and Labrador
Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
St. John's, Newfoundland and Labrador, Canada, A1A 3R5
Canada, Ontario
Sarnia, Ontario, Canada, N7T 4X3
Toronto, Ontario, Canada, M9V 4B4
Woodstock, Ontario, Canada, N4S 5P5
Canada, Quebec
Montreal, Quebec, Canada, H2P 2M1
Montreal, Quebec, Canada, H1T 1C8
Sainte-foy, Quebec, Canada, G1V 4G2
St-jerome, Quebec, Canada, J7Z 5T3
Trois-Rivières, Quebec, Canada, G8T 7A1
Czech Republic
Hodonin, Czech Republic, 695 01
Jicícin, Czech Republic, 50601
Marianske Lazne, Czech Republic, 353 01
Ostrava - Poruba, Czech Republic, 708 52
Rakovník, Czech Republic, 269 01
Germany
Berlin, Germany, 13125
Köln, Germany, 50937
Hungary
Komarom, Hungary, 2921
Nagykanizsa, Hungary, 8800
Nyíregyháza, Hungary, 4400
Sopron, Hungary, 9400
New Zealand
Auckland, New Zealand
Auckland, New Zealand, 1001
Christchurch, New Zealand, 8011
Nelson, New Zealand, 7001
Tauranga, New Zealand, 3110
Norway
Elverum, Norway, 2401
Hamar, Norway, 2317
Oslo, Norway, 0160
Oslo, Norway, 0027
Sandnes, Norway, 4313
Slovakia
Bardejov, Slovakia, 08501
Bratislava, Slovakia, 841 07
Presov, Slovakia, 080 01
Rimavska Sobota, Slovakia, 979 01
South Africa
Cape Town, South Africa, 7130
Cape Town, South Africa, 7505
Centurion, South Africa, 0157
Pretoria, South Africa, 0181
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 29, 2014