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Study ID: Novartis LCZ696D2302 PARALLAX

Title:

A 24-week, randomized, double-blind, multi-center, parallel group, active controlled study to evaluate the effect of LCZ696 on NT-proBNP, symptoms, exercise function and safety compared to individualized medical management of comorbidities in patients with heart failure and preserved ejection fraction

Description:
Title: Novartis LCZ696D2302 PARALLAX. Description: The Novartis LCZ696D2302 PARALLAX study is looking at the safety and effectiveness of an investigational medication: sacubitril/valsartan (Entresto®). The participants will also continue to receive routine care for heart failure. The main purpose of this study is to investigate the clinical efficacy (how well something works to treat a condition) and safety of the study drug in subjects who have heart failure (HF) with preserved ejection fraction (HFpEF), a condition that affects the heart. This study will tell us if the investigational medication, sacubitril/valsartan (Entresto®) impacts heart failure symptoms and exercise capacity in patients who have HFpEF. The subject will be placed into one of three groups depending on the medications they were receiving prior to being enrolled in the study. Subjects previously treated with an ACE inhibitor will be place in the sacubitril/valsartan (Entresto®) vs enalapril group. Subjects previously treated with an ARB will be placed in the sacubitril/valsartan (Entresto®) vs valsartan group. Subjects not receiving either an ACE inhibitor or ARB will be placed in the sacubitril/valsartan (Entresto®) vs placebo group (placebo is a “dummy treatment” which looks like sacubitril/valsartan (Entresto®) but contains no active ingredients). This is a phase III study meaning the study drug is tested in a large number of subjects to confirm and expand information on its safety and usefulness. The medication being tested in this study is called sacubitril/valsartan (Entresto®). This medication has been approved by the FDA for the treatment of people with symptomatic chronic heart failure and reduced ejection fraction (HFrEF). It has not been approved for the treatment of heart failure (HF) with preserved ejection fraction (HFpEF). The medicine being tested in this study is not currently available for patients with HFpEF to receive a prescription for and/or to buy in the United States.
Location:
Sioux Falls Region
Principal Investigator:
Orvar Jonsson, MD
Disease:
Heart
Stage:
Phase III
Status:
Active - Open to Accrual

For more information, call or email Bismarck Clinical Research at (701) 323-5760, Fargo and Bemidji Clinical Research at (701) 234-5890, or Sioux Falls Clinical Research at (605) 328-1368.