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This study was terminated early because the primary endpoint of PARAGON-HF was not met.
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCZ696 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCZ696 | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 27 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Seto | Aichi-ken | 489-8642 | Japan | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novartisclinicaltrials.com | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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.
A total of 52 participants were enrolled across 17 centers in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 17, 2018 | Nov 6, 2020 |
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|
|
| Chikushino-shi |
| Fukuoka |
| 818-8516 |
| Japan |
| Novartis Investigative Site | Ōgaki | Gifu | 503-8502 | Japan |
| Novartis Investigative Site | Maebashi | Gunma | 371 8511 | Japan |
| Novartis Investigative Site | Kanazawa | Ishikawa-ken | 920 8650 | Japan |
| Novartis Investigative Site | Morioka | Iwate | 020 0066 | Japan |
| Novartis Investigative Site | Kan’onjichō | Kagawa-ken | 769-1695 | Japan |
| Novartis Investigative Site | Takamatsu | Kagawa-ken | 760 8557 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 227-8501 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 236 0051 | Japan |
| Novartis Investigative Site | Sendai | Miyagi | 980 8574 | Japan |
| Novartis Investigative Site | Kashihara | Nara | 634 8522 | Japan |
| Novartis Investigative Site | Sayama | Saitama | 350-1305 | Japan |
| Novartis Investigative Site | Kusatsu | Shiga | 525 8585 | Japan |
| Novartis Investigative Site | Hachiōji | Tokyo | 192-0918 | Japan |
| Novartis Investigative Site | Itabashi-ku | Tokyo | 173-8610 | Japan |
| Novartis Investigative Site | Shinagawa-ku | Tokyo | 142-8666 | Japan |
| Safety Set (SAF) | All subjects who received at least one dose of study drug |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety set (SAF) included all participants who received at least one dose of study drug | Posted | Count of Participants | Participants | Up to 27 weeks |
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|
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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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 52 | 8 | 52 | 16 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Macular fibrosis | Eye disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (22.1) | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 17, 2019 | Nov 6, 2020 | SAP_000.pdf |
| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
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