Heart Failure With Preserved Ejection Fraction (HFpEF)
Conditions
Keywords
heart failure with preserved ejection fraction, Japanese patients, extension study, long-term safety and tolerability, open-label
Brief summary
This study evaluated the safety and tolerability of LCZ696 treatment in Japanese heart failure patients (NYHA Class II-IV) with preserved ejection fraction after CLCZ696D2301 (PARAGON-HF).
Detailed description
This study was an open-label extension study following the PARAGON-HF. Patients who have completed the PARAGON-HF were eligible to participate. During the study, open-label LCZ696 was taken in addition to background treatments of comorbidities. All subjects were treated with LCZ696 (sacubitril/valsartan) at maximally tolerated dosed with a target dose of 200 mg b.i.d (twice a day). The subject were to continue to receive LCZ696 until it became commercially available, or for a period up to 24 months from the first patient enrolled in this study whichever came first. However, this study was terminated early based on the pre-defined early termination criteria of the primary endpoint of PARAGONHF was not met in the protocol.
Interventions
DRUGLCZ696
Starting dose was either 50 mg b.i.d. or 100 mg b.i.d. largely depending on the last dose level taken by the patient at the time of completing PARAGON-HF and patient condition. The dose level was gradually up-titrated with the goal of reaching the target dose of 200 mg b.i.d. as soon as tolerated by the patient
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent must be obtained before any assessment is performed. * Patients who have completed LCZ696D2301 and are able to be safely enrolled into this study as judged by the investigator.
Exclusion criteria
* Patients who discontinued study drug treatment during LCZ696D2301 due to an event or intercurrent illness. Eligibility can be re-considered if the event has resolved and no longer represents a risk to the patient and the patient can safely tolerate the administration of LCZ696 per the investigator's assessment. * Any medical condition 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. * Patients who have experience of angioedema event(s) which occurred and reported by the investigator during LCZ696D2301. * Pregnant or nursing (lactating) women. * Women of childbearing potential unless they are using highly effective methods of contraception. Other protocol-defined inclusion/exclusion may apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events and Serious Adverse Events | Up to 27 weeks | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. Any sign or symptom that occured from first dose of study treatment until end of study treatment. |
Countries
Japan
Participant flow
Recruitment details
A total of 52 participants were enrolled across 17 centers in Japan.
Pre-assignment details
This study was terminated early based on the pre defined early termination criteria of the primary endpoint of PARAGON-HF (CLCZ696D2301) was not met in the protocol.
Participants by arm
| Arm | Count |
|---|---|
| LCZ696 Starting dose was either 50 mg b.i.d. or 100 mg b.i.d. largely depending on the last dose level taken by the patient at the time of completing PARAGON-HF and patient condition. The dose level was gradually up-titrated with the goal of reaching the target dose of 200 mg b.i.d. as soon as tolerated by the patient | 52 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Study terminated by sponsor | 50 |
Baseline characteristics
| Characteristic | LCZ696 |
|---|---|
| Age, Continuous | 77.37 Years STANDARD_DEVIATION 7.608 |
| Race/Ethnicity, Customized Asian | 52 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 52 |
| other Total, other adverse events | 16 / 52 |
| serious Total, serious adverse events | 8 / 52 |
Outcome results
Primary
Number of Participants With Adverse Events and Serious Adverse Events
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. Any sign or symptom that occured from first dose of study treatment until end of study treatment.
Time frame: Up to 27 weeks
Population: Safety set (SAF) included all participants who received at least one dose of study drug
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LCZ696 50 mg | Number of Participants With Adverse Events and Serious Adverse Events | Participants experiencing Adverse Events | 40 Participants |
| LCZ696 50 mg | Number of Participants With Adverse Events and Serious Adverse Events | Participants experiencing Serious Adverse Events | 8 Participants |