EUCTR2014-001971-30-IT
Active, not recruiting
Phase 1
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
ovartis Farma SPA0 sites5,000 target enrollmentDecember 16, 2014
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Heart failure with reduced ejection fraction
- Sponsor
- ovartis Farma SPA
- Enrollment
- 5000
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •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 2400
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 2600
Exclusion Criteria
- •1\. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half\-lives of enrollment, whichever is
- •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 \< 100 mmHg at Visit 1 (screening)
- •7\. Estimated GFR \< 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 \> 5\.2mmol/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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Safety and tolerability during open-label treatment with LCZ696 in patients with chronic heart failure and reduced ejection fractioHeart failure with reduced ejection fractionMedDRA version: 17.0Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2014-001971-30-LVovartis Pharma services AG5,000
Active, not recruiting
Phase 1
Safety and tolerability during open-label treatment with LCZ696 in patients with chronic heart failure and reduced ejection fractioHeart failure with reduced ejection fractionMedDRA version: 18.1Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2014-001971-30-DKovartis Pharma services AG5,000
Active, not recruiting
Phase 1
Safety and tolerability during open-label treatment with LCZ696 in patients with chronic heart failure and reduced ejection fractioHeart failure with reduced ejection fractionMedDRA version: 19.0Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2014-001971-30-BGovartis Pharma services AG5,000
Completed
Phase 3
A multicenter study to evaluate safety and tolerability in patients with chronic heart failure and reduced ejection fraction from PARADIGM-HF receiving open label LCZ696Heart Failure10019280NL-OMON42095ovartis Pharma B.V.75
Active, not recruiting
Phase 1
Safety and tolerability during open-label treatment with LCZ696 in patients with chronic heart failure and reduced ejection fractioHeart failure with reduced ejection fractionMedDRA version: 19.0Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2014-001971-30-PLovartis Pharma services AG5,000