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 is ongoing, but not recruiting participants.
Sponsor:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01609140
First received: May 24, 2012
Last updated: December 5, 2012
Last verified: December 2012
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Purpose
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.
| 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 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | September 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609140
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Hide Study LocationsLocations
| United States, Arizona | |
| Litchfield Park, Arizona, United States, 85340 | |
| 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 | |
| Willimgton, 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 | |
| Canada, Ontario | |
| Sarnia, Ontario, Canada, N7T 4X3 | |
| Toronto, Ontario, Canada, M9V4B4 | |
| 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 | |
| Canada | |
| St. John's, Canada, A1A 3R5 | |
| Czech Republic | |
| Hodonin, Czech Republic, 695 01 | |
| Jiícin, Czech Republic, 50601 | |
| Marianske Lazne, Czech Republic, 353 01 | |
| Ostrava - Poruba, Czech Republic, 708 52 | |
| Rakovník, Czech Republic, 269 01 | |
| Germany | |
| Berlin, Germany, 12203 | |
| Berlin, Germany, 13125 | |
| Köln, Germany, 50937 | |
| Hungary | |
| Komarom, Hungary, 2921 | |
| Nagykanizsa, Hungary, 8800 | |
| Nyíregyháza, Hungary, 4400 | |
| Sopron, Hungary, 9400 | |
| Szeged, Hungary, 6720 | |
| New Zealand | |
| Auckland, New Zealand, 1640 | |
| Auckland, New Zealand, 1001 | |
| Christchurch, New Zealand, 8140 | |
| 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, 085 01 | |
| Bratislava, Slovakia, 841 07 | |
| Presov, Slovakia, 080 01 | |
| Presov, Slovakia, 08001 | |
| Rimavska Sobota, Slovakia, 979 01 | |
| South Africa | |
| Centurion, South Africa, 0157 | |
| Parow, South Africa, 7505 | |
| Pretoria, South Africa, 0181 | |
| Sommerset West, South Africa, 7129 | |
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: | December 5, 2012 |
| 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 May 21, 2013