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

NCT01609140 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2016-11-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

MPSK3169A

Dose regimen A, repeating subcutaneous injections every 4 weeks

DRUG

MPSK3169A

Dose regimen E, repeating subcutaneous injections every 4 weeks

DRUG

MPSK3169A

Dose regimen D, repeating subcutaneous injections every 4 weeks

DRUG

MPSK3169A

Dose regimen C, repeating subcutaneous injections every 4 weeks

DRUG

MPSK3169A

Dose regimen B, repeating subcutaneous injections every 4 weeks

DRUG

Placebo

Repeating subcutaneous injections of placebo every 4 weeks

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Genentech, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-05-31
Completion
2013-07-31

Countries

  • United States
  • Canada
  • Czechia
  • Germany
  • Hungary
  • New Zealand
  • Norway
  • Slovakia
  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01609140 on ClinicalTrials.gov