Trial Outcomes & Findings for An Open-label Extension Study Evaluating Safety and Tolerability of LCZ696 in Subjects Who Completed PARAGON-HF in Japan. (NCT NCT03909295)
NCT ID: NCT03909295
Last Updated: 2021-10-08
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
52 participants
Primary outcome timeframe
Up to 27 weeks
Results posted on
2021-10-08
Participant Flow
A total of 52 participants were enrolled across 17 centers in Japan.
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.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
Safety Set (SAF)
|
52
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
52
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Study terminated by sponsor
|
50
|
Baseline Characteristics
An Open-label Extension Study Evaluating Safety and Tolerability of LCZ696 in Subjects Who Completed PARAGON-HF in Japan.
Baseline characteristics by cohort
| Measure |
LCZ696
n=52 Participants
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
|
|---|---|
|
Age, Continuous
|
77.37 Years
STANDARD_DEVIATION 7.608 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
52 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 27 weeksPopulation: Safety set (SAF) included all participants who received at least one dose of study drug
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.
Outcome measures
| Measure |
LCZ696 50 mg
n=52 Participants
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
|
|---|---|
|
Number of Participants With Adverse Events and Serious Adverse Events
Participants experiencing Adverse Events
|
40 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events
Participants experiencing Serious Adverse Events
|
8 Participants
|
Adverse Events
LCZ696
Serious events: 8 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LCZ696
n=52 participants at risk
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
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
1/52 • Adverse events were collected from first dose of study treatment until end of study treatment (up to 27 weeks).
Any sign or symptom that occured from first dose of study treatment until end of study treatment (27 weeks).
|
|
Cardiac disorders
Cardiac failure chronic
|
1.9%
1/52 • Adverse events were collected from first dose of study treatment until end of study treatment (up to 27 weeks).
Any sign or symptom that occured from first dose of study treatment until end of study treatment (27 weeks).
|
|
Eye disorders
Macular fibrosis
|
1.9%
1/52 • Adverse events were collected from first dose of study treatment until end of study treatment (up to 27 weeks).
Any sign or symptom that occured from first dose of study treatment until end of study treatment (27 weeks).
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.9%
1/52 • Adverse events were collected from first dose of study treatment until end of study treatment (up to 27 weeks).
Any sign or symptom that occured from first dose of study treatment until end of study treatment (27 weeks).
|
|
Gastrointestinal disorders
Nausea
|
1.9%
1/52 • Adverse events were collected from first dose of study treatment until end of study treatment (up to 27 weeks).
Any sign or symptom that occured from first dose of study treatment until end of study treatment (27 weeks).
|
|
Infections and infestations
Gastroenteritis
|
1.9%
1/52 • Adverse events were collected from first dose of study treatment until end of study treatment (up to 27 weeks).
Any sign or symptom that occured from first dose of study treatment until end of study treatment (27 weeks).
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.9%
1/52 • Adverse events were collected from first dose of study treatment until end of study treatment (up to 27 weeks).
Any sign or symptom that occured from first dose of study treatment until end of study treatment (27 weeks).
|
|
Nervous system disorders
Embolic stroke
|
1.9%
1/52 • Adverse events were collected from first dose of study treatment until end of study treatment (up to 27 weeks).
Any sign or symptom that occured from first dose of study treatment until end of study treatment (27 weeks).
|
|
Nervous system disorders
Headache
|
1.9%
1/52 • Adverse events were collected from first dose of study treatment until end of study treatment (up to 27 weeks).
Any sign or symptom that occured from first dose of study treatment until end of study treatment (27 weeks).
|
Other adverse events
| Measure |
LCZ696
n=52 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
9.6%
5/52 • Adverse events were collected from first dose of study treatment until end of study treatment (up to 27 weeks).
Any sign or symptom that occured from first dose of study treatment until end of study treatment (27 weeks).
|
|
Infections and infestations
Nasopharyngitis
|
13.5%
7/52 • Adverse events were collected from first dose of study treatment until end of study treatment (up to 27 weeks).
Any sign or symptom that occured from first dose of study treatment until end of study treatment (27 weeks).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.7%
4/52 • Adverse events were collected from first dose of study treatment until end of study treatment (up to 27 weeks).
Any sign or symptom that occured from first dose of study treatment until end of study treatment (27 weeks).
|
|
Vascular disorders
Hypotension
|
5.8%
3/52 • Adverse events were collected from first dose of study treatment until end of study treatment (up to 27 weeks).
Any sign or symptom that occured from first dose of study treatment until end of study treatment (27 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER