NCT01609140

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 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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

• Coronary Heart Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-05-01
• Completion: 2013-07-01
• First posted: 2012-05-31
• Last updated: 2016-11-02

Locations

73 sites across 9 countries: United States, Canada, Czechia, Germany, Hungary, New Zealand, Norway, Slovakia, South Africa