Trial Search Results

Registrational Study With Omecamtiv Mecarbil/AMG 423 to Treat Chronic Heart Failure With Reduced Ejection Fraction

The purpose of this study is to determine if treatment with omecamtiv mecarbil/AMG 423 when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in subjects with chronic HFrEF.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Amgen

Collaborator: Servier

Stanford Investigator(s):

Intervention(s):

  • Drug: Omecamtiv Mecarbil
  • Drug: Placebo

Phase:

Phase 3

Eligibility


Key Inclusion Criteria:

   - Subject has provided informed consent

   - Male or female, ≥ 18 to ≤ 85 years

   - History of chronic HF (defined as requiring treatment for HF for a minimum of 30 days
   before randomization)

   - LVEF ≤ 35%, per subjects most recent medical record, within 12 months prior to
   screening.

   - NYHA class II to IV at most recent screening assessment.

   - Managed with HF SoC therapies consistent with regional clinical practice guidelines
   according to investigator judgment of subject's clinical status

   - Current hospitalization with primary reason of HF OR one of the following events
   within 1 year of screening: hospitalization with primary reason of HF; urgent visit to
   emergency department (ED) with primary reason of HF.

   - Elevated BNP or NT-proBNP

Other Inclusion Criteria May apply

Key Exclusion Criteria:

   - Currently receiving treatment in another investigational device or drug study, or < 30
   days since ending treatment on another investigational device or drug study(ies).
   Other investigational procedures while participating in this study are excluded.

   - Malignancy within 5 years prior to randomization with the following exceptions:
   localized basal or squamous cell carcinoma of the skin, cervical intraepithelial
   neoplasia, stage 1 prostate carcinoma, breast ductal carcinoma in situ.

   - Subject has known sensitivity to any of the products or components to be administered
   during testing

Other Exclusion Criteria May apply

Ages Eligible for Study

18 Years - 85 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting