Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fractio
- Conditions
- Health Condition 1: null- Chronic Heart Failure With Reduced Ejection Fraction.
- Registration Number
- CTRI/2015/09/006167
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4900
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.
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
to LCZ696
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method