CTRI/2015/09/006167已完成3 期
A Multicenter Study to Evaluate Safety and Tolerability in Patients With Chronic Heart Failure and Reduced Ejection Fraction From PARADIGM-HF Receiving Open Label LCZ696 - NA
ovartis Healthcare Pvt Ltd0 个研究点目标入组 4,900 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4,900
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Written informed consent for the extension must be obtained before any assessment is performed.
- •2.Patients who have completed PARADIGM-HF (protocol CLCZ696B2314) and are able to be safely enrolled into the open-label trial as judged by the investigator.
排除标准
- •1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives
- •of enrollment, whichever is longer
- •2. History of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical
- •classes, ACEIs, ARBs, or NEP inhibitors as well as known or suspected contraindications
- •3. Known history of angioedema
- •4. Requirement of simultaneous treatment with both ACEIs and ARBs
- •5. Current acute decompensated HF (exacerbation of chronic HF manifested by signs and
- •symptoms that may require intravenous therapy)
- •6. Symptomatic hypotension and/or a SBP Less than 100 mmHg at Visit 1 (screening)
- •7. Estimated GFR less than 30 mL/min/1.73m2 as measured by the simplified MDRD formula at
- •Visit 1 (screening)
- •8. Presence of bilateral renal artery stenosis
- •9. Serum potassium greater than 5.2 mmol/L at Visit 1 (screening)
- •10. Evidence of hepatic disease as determined by any one of the following: AST or ALT
- •values exceeding 3 x ULN at Visit 1, history of hepatic encephalopathy, history of
- •esophageal varices, or history of portacaval shunt
- •11. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
- •female after conception and until the termination of gestation, confirmed by a positive
- •hCG laboratory test (gearter than 5 mIU/mL)
- •12. Women of child-bearing potential, defined as all women physiologically capable of
- •becoming pregnant, including women whose career, lifestyle, or sexual orientation
- •precludes intercourse with a male partner and women whose partners have been sterilized
- •by vasectomy or other means, UNLESS they are using two birth control methods. The two
- •methods can be a double barrier method (if accepted by the local regulatory authority and
- •ethics committee) or a barrier method plus a hormonal method
- •o Adequate barrier methods of contraception include: diaphragm, condom (by the
- •partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal
- •contraceptives include any marketed contraceptive agent that includes an estrogen
- •and/or a progesterone agent.
- •o Reliable contraception should be maintained throughout the study and for 7 days after
- •study drug discontinuation.
- •o Women are considered post-menopausal and not of child bearing potential if they have
- •had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical
- •profile (e.g. age appropriate, history of vasomotor symptoms) or six months of
- •spontaneous amenorrhea with serum FSH levels greater than 40 mIU/mL [for US only: and
- •estradiol less than 20 pg/mL] or have had surgical bilateral oophorectomy (with or without
- •hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when
- •the reproductive status of the woman has been confirmed by follow up hormone level
- •assessment.
- •13. Any condition, not identified in the protocol that in the opinion of the investigator is likely
- •to prevent the patient from safely tolerating LCZ696 or complying with the requirements
- •of the study.
研究者
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