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Coronary Heart DiseasePhase 2NCT01609140

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 2 study testing MPSK3169A in people with Coronary Heart Disease, run by Genentech, Inc. at 73 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronary Heart Disease
What is being tested?
MPSK3169A
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
248 participants
Where
73 sitesin 9 countries
Study dates
May 2012to Jul 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

73 sites in 9 countries.

73 sites in 9 countries

United States34 sites

  • Study site

    Auburn, Maine, 04210

  • Study site

    Baltimore, Maryland, 21209

  • Study site

    Bethesda, Maryland, 20817

  • Study site

    Boerne, Texas, 78006

  • Study site

    Boise, Idaho, 83704

  • Study site

    Bristol, Tennessee, 37620

  • Study site

    Carmichael, California, 95608

  • Study site

    Cincinnati, Ohio, 45212

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Dallas, Texas, 75230

  • Study site

    Dallas, Texas, 75231

  • Study site

    Fargo, North Dakota, 58103

  • Study site

    Goodyear, Arizona, 85395

  • Study site

    Greer, South Carolina, 29650

  • Study site

    Houston, Texas, 77030

  • Study site

    Indianapolis, Indiana, 46260

  • Study site

    Iowa City, Iowa, 52242

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Knoxville, Tennessee, 27912

  • Study site

    Mt. Pleasant, South Carolina, 29464

  • Study site

    Oklahoma City, Oklahoma, 73103

  • Study site

    Ponte Verde, Florida, 32081

  • Study site

    Rapid City, South Dakota, 57701

  • Study site

    Richmond, Virginia, 23294

  • Study site

    Rochester, New York, 14609

  • Study site

    Spartanburg, South Carolina, 29303

  • Study site

    Spring Valley, California, 91978

  • Study site

    Springdale, Ohio, 45246

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Tulsa, Oklahoma, 74136

  • Study site

    Walnut Creek, California, 94598

  • Study site

    Wenatchee, Washington, 98801

  • Study site

    Wildomar, California, 92595

  • Study site

    Wilmington, North Carolina, 28401

Other trials in United States

Canada10 sites

  • Study site

    Montreal, Quebec, H1T 1C8

  • Study site

    Montreal, Quebec, H2P 2M1

  • Study site

    Mount Pearl, Newfoundland and Labrador, A1N 1W7

  • Study site

    Saint-Jérôme, Quebec, J7Z 5T3

  • Study site

    Sainte-Foy, Quebec, G1V 4G2

  • Study site

    Sarnia, Ontario, N7T 4X3

  • Study site

    St. John's, Newfoundland and Labrador, A1A 3R5

  • Study site

    Toronto, Ontario, M9V 4B4

  • Study site

    Trois-Rivières, Quebec, G8T 7A1

  • Study site

    Woodstock, Ontario, N4S 5P5

Other trials in Canada

Czechia5 sites

  • Study site

    Hodonín, 695 01

  • Study site

    Jičícin, 50601

  • Study site

    Mariánské Lázně, 353 01

  • Study site

    Ostrava - Poruba, 708 52

  • Study site

    Rakovník, 269 01

Other trials in Czechia

New Zealand5 sites

  • Study site

    Auckland, 1001

  • Study site

    Auckland

  • Study site

    Christchurch, 8011

  • Study site

    Nelson, 7001

  • Study site

    Tauranga, 3110

Other trials in New Zealand

Norway5 sites

  • Study site

    Elverum, 2401

  • Study site

    Hamar, 2317

  • Study site

    Oslo, 0027

  • Study site

    Oslo, 0160

  • Study site

    Sandnes, 4313

Other trials in Norway

Hungary4 sites

  • Study site

    Komárom, 2921

  • Study site

    Nagykanizsa, 8800

  • Study site

    Nyíregyháza, 4400

  • Study site

    Sopron, 9400

Other trials in Hungary

Slovakia4 sites

  • Study site

    Bardejov, 08501

  • Study site

    Bratislava, 841 07

  • Study site

    Prešov, 080 01

  • Study site

    Rimavská Sobota, 979 01

Other trials in Slovakia

South Africa4 sites

  • Study site

    Cape Town, 7130

  • Study site

    Cape Town, 7505

  • Study site

    Centurion, 0157

  • Study site

    Pretoria, 0181

Other trials in South Africa

Germany2 sites

  • Study site

    Berlin, 13125

  • Study site

    Cologne, 50937

Other trials in Germany

About this study

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

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.

Being tested
MPSK3169A, Placebo
Keywords
Hyperlipidemia, Dyslipidemia
Medical subject headings
Coronary Disease, Hyperlipidemias, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MPSK3169ADrug

    Dose regimen A, repeating subcutaneous injections every 4 weeks

  • MPSK3169ADrug

    Dose regimen E, repeating subcutaneous injections every 4 weeks

  • MPSK3169ADrug

    Dose regimen D, repeating subcutaneous injections every 4 weeks

  • MPSK3169ADrug

    Dose regimen C, repeating subcutaneous injections every 4 weeks

  • MPSK3169ADrug

    Dose regimen B, repeating subcutaneous injections every 4 weeks

  • PlaceboDrug

    Repeating subcutaneous injections of placebo every 4 weeks

Study groups in NCT01609140
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Drug: MPSK3169A
BExperimentalNot described
Receives: Drug: MPSK3169A
CExperimentalNot described
Receives: Drug: MPSK3169A
DExperimentalNot described
Receives: Drug: MPSK3169A
EExperimentalNot described
Receives: Drug: MPSK3169A
FPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute change from baseline in LDL-c concentration

    Measured: at Day 169

Secondary outcomes (5)

  1. Absolute change from baseline in LDL-c concentration for each arm at the nadir for that arm

    Measured: over the 24 week treatment period

  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

    Measured: up to Day 169

  3. Percent change from baseline in LDL-c concentration at Day 169 and at the nadir for each arm

    Measured: at Day 169 and over the 24 week treatment period

  4. Percent and absolute change from baseline in LDL-c concentration at all other designated timepoints

    Measured: 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

    Measured: at Day 169 and over the 24 week treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionMay 2013
  4. Study completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01609140
Sponsor's protocol ID
GC28210
Status last verified
Nov 2016
First submitted
24 May 2012
Last updated
2 Nov 2016
Results posted
No

Publications

  • Baruch A, Mosesova S, Davis JD, Budha N, Vilimovskij A, Kahn R, Peng K, Cowan KJ, Harris LP, Gelzleichter T, Lehrer J, Davis JC Jr, Tingley WG. Effects of RG7652, a Monoclonal Antibody Against PCSK9, on LDL-C, LDL-C Subfractions, and Inflammatory Biomarkers in Patients at High Risk of or With Established Coronary Heart Disease (from the Phase 2 EQUATOR Study). Am J Cardiol. 2017 May 15;119(10):1576-1583. doi: 10.1016/j.amjcard.2017.02.020. Epub 2017 Mar 1.

    PubMed 28343601

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MPSK3169A in people with Coronary Heart Disease, run by Genentech, Inc. at 73 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, Canada, Czechia, New Zealand, Norway and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute change from baseline in LDL-c concentration (time frame: at Day 169). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01609140, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.

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