Omecamtiv Mecarbil Post-trial Access Protocol for Subjects Completing Study 20110203 GALACTIC-HF - Omecamtiv Mecarbil Post-trial Access Protocol

Amgen Inc.0 个研究点目标入组 1,286 人开始时间: 2020年8月6日最近更新: 2021年3月8日

研究概览

暂无简介。

•Subjects are eligible to be included in the study only if all of the following criteria apply:
•101 Subject has provided GALACTIC-HF PTA informed consent prior to initiation of any study specific activities/procedures.
•102 Subject has completed GALACTIC-HF.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 480
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 665

•Subjects are excluded from the study if any of the following criteria apply:
•201 Investigational product was permanently discontinued during GALACTIC-HF due to protocol-specified reason.
•202 Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 5 days after the last dose of treatment.
•203 Female subjects of childbearing potential unwilling to use 2 acceptable methods of effective contraception during treatment with OM and for an additional 5 days after the last dose of treatment. Refer to Section 11.5 for additional
•contraceptive information.
•204 Female subjects of childbearing potential with a positive pregnancy test
•assessed on day 1 by a urine pregnancy test.
•205 Subject has known sensitivity to any of the products or components to be
•administered during dosing.
•206 History or evidence of any clinically significant disorder, condition or disease that,
•in the opinion of the investigator or Amgen physician, if consulted, would pose a
•risk to subject safety or interfere with the study evaluation, procedures or
•completion.

发起方

Amgen Inc.