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The purpose of this study is to assess the long-term safety, tolerability and efficacy of LCZ696.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCZ696 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCZ696 | Drug | Participants received LCZ696 200 mg as the starting dose with optional down titration to 100 mg for tolerance and optional up titration to 400 mg for adequate blood pressure control. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment) | Participants were monitored throughout the study for adverse events, serious adverse events and deaths. | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Maximum Treatment) | Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement. | Baseline, 12 months |
| Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Mono or Combination Therapy) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Chongqing | Chongqing Municipality | 400042 | China | ||
| Novartis Investigative Site |
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Analyses on this open label extension study were performed according to treatment groups defined by the maximum and highest dose treatments received: 1) LCZ696 200 mg, 2) LCZ696 400 mg, 3) LCZ696 400 mg/Amlodipine, 4) LCZ696 400 mg/Amlodipine/HCTZ, 5) LCZ696 Mono (LCZ696 only), and 6) LCZ696 Combination LCZ696 with Amlodipine and/or HCTZ).
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| ID | Title | Description |
|---|---|---|
| FG000 | LCZ696 200 mg | Participants received LCZ696 200 mg by mouth once daily (qd). |
| FG001 | LCZ696 400 mg | Participants received LCZ696 400 mg by mouth qd. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Extension by Maximum Treatment |
|
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| Amlodipine | Drug | Optional add-on of amlodipine (5-10 mg) was allowed (as applicable per local country regulations) for adequate blood pressure control. |
|
| Hydrochlorothiazide (HCTZ) | Drug | Optional add-on of hydrochlorothiazide (HCTZ) (12.5-25 mg) was allowed (as applicable per local country regulations) for adequate blood pressure control. |
|
Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement. |
| Baseline, 12 months |
| Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Maximum Treatment) | Blood pressure (BP) control is defined as BP <140/90 mmHg. | Baseline to 12 months |
| Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Mono or Combination Therapy) | Blood pressure (BP) control is defined as BP <140/90 mmHg. | Baseline to 12 months |
| Shijiazhuang |
| Hebei |
| 050000 |
| China |
| Novartis Investigative Site | Hangzhou | Zhejiang | 310006 | China |
| Novartis Investigative Site | Beijing | 100044 | China |
| Novartis Investigative Site | Beijing | 100730 | China |
| Novartis Investigative Site | Tianjin | 300142 | China |
| Novartis Investigative Site | Yokohama | Kanagawa | 231-0023 | Japan |
| Novartis Investigative Site | Shimotsuke | Tochigi | 329-0498 | Japan |
| Novartis Investigative Site | Bunkyo-ku | Tokyo | 113-0031 | Japan |
| Novartis Investigative Site | Chiyoda-ku | Tokyo | 100-0005 | Japan |
| Novartis Investigative Site | Kiyose | Tokyo | 204-0021 | Japan |
| Novartis Investigative Site | Kunitachi | Tokyo | 186-0001 | Japan |
| Novartis Investigative Site | Minato-ku | Tokyo | 105-7390 | Japan |
| Novartis Investigative Site | Minato-ku | Tokyo | 108-0075 | Japan |
| Novartis Investigative Site | Ōta-ku | Tokyo | 143-0023 | Japan |
| Novartis Investigative Site | Shinagawa-ku | Tokyo | 141-0032 | Japan |
| Novartis Investigative Site | Shinagawa-ku | Tokyo | 142-0053 | Japan |
| Novartis Investigative Site | Shinagawa-ku | Tokyo | 142-0063 | Japan |
| Novartis Investigative Site | Toshima-ku | Tokyo | 171-0021 | Japan |
| Novartis Investigative Site | Bucheon-si | Gyeonggi-do | 424-717 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 137-701 | South Korea |
| Novartis Investigative Site | Koyang | Kyunggi | 410-719 | South Korea |
| Novartis Investigative Site | Daegu | 705-703 | South Korea |
| Novartis Investigative Site | Seoul | 150-950 | South Korea |
| Novartis Investigative Site | Seoul | 152-703 | South Korea |
| Novartis Investigative Site | Taichung | Taiwan | 40447 | Taiwan |
| Novartis Investigative Site | Taipei | Taiwan | 10002 | Taiwan |
| Novartis Investigative Site | Taipei | Taiwan | 10449 | Taiwan |
| Novartis Investigative Site | Taipei | Taiwan | 114 | Taiwan |
| Novartis Investigative Site | Changhua | 500 | Taiwan |
| Novartis Investigative Site | Bangkok | 10400 | Thailand |
| Novartis Investigative Site | Bangkok | 10700 | Thailand |
| Novartis Investigative Site | Chiang Mai | 50200 | Thailand |
| FG002 | LCZ606 400 mg/Amlodipine | Participants received LCZ696 400 mg by mouth qd and amlodipine 5mg up to 10 mg by mouth as needed (prn). |
| FG003 | LCZ696 400 mg/Amlodipine/HCTZ | Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn. |
| FG004 | LCZ696 Monotherapy | Participants received LCZ696 only. |
| FG005 | LCZ696 Combination Therapy | Participants received LCZ696 with amlodipine and/or HCTZ. |
| Down Titrated to 100 mg |
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| COMPLETED |
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| NOT COMPLETED |
|
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| Extension by Mono or Combination Therapy |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | LCZ696 200 mg | Participants received LCZ696 200 mg by mouth once daily (qd). |
| BG001 | LCZ696 400 mg | Participants received LCZ696 400 mg by mouth qd. |
| BG002 | LCZ606 400 mg/Amlodipine | Participants received LCZ696 400 mg by mouth qd and amlodipine 5mg up to 10 mg by mouth as needed (prn). |
| BG003 | LCZ696 400 mg/Amlodipine/HCTZ | Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn. |
| BG004 | Total | Total of all reporting groups |
| 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 |
|
| 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, Serious Adverse Events, and Deaths (Analysis by Actual Treatment) | Participants were monitored throughout the study for adverse events, serious adverse events and deaths. | Actual extension treatment received: The participants are included in each treatment group for which they received treatment. For example, if a participant started on LCZ696 200 mg but was then down-titrated to LCZ696 100 mg, the participant was counted once in the LCZ696 100 mg group and once in the LCZ696 200 mg group. | Posted | Number | Participants | Baseline to 12 months |
|
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| ||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Maximum Treatment) | Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement. | Treated set: The treated set included all participants who received at least one dose of extension study medication. One participant in the LCZ696 400 mg/Amlodopine group discontinued after 1 day in the extension study without having any BP measurements taken during the extension. Therefore, this participant was excluded from the analysis. | Posted | Mean | Standard Deviation | mmHg | Baseline, 12 months |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Mono or Combination Therapy) | Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement. | Treated set: The treated set included all participants who received at least one dose of extension study medication. One participant in the LCZ696 combination group discontinued after 1 day in the extension study without having any BP measurements taken during the extension. Therefore, this participant was excluded from the analysis. | Posted | Mean | Standard Deviation | mmHg | Baseline, 12 months |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Maximum Treatment) | Blood pressure (BP) control is defined as BP <140/90 mmHg. | Treated set: The treated set included all participants who received at least one dose of extension study medication. One participant in the LCZ696 400 mg/Amlodopine group discontinued after 1 day in the extension study without having any BP measurements taken during the extension. Therefore, this participant was excluded from the analysis. | Posted | Number | Participants | Baseline to 12 months |
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| Secondary | Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Mono or Combination Therapy) | Blood pressure (BP) control is defined as BP <140/90 mmHg. | Treated set: The treated set included all participants who received at least one dose of extension study medication. One participant in the LCZ696 combination group discontinued after 1 day in the extension study without having any BP measurements taken during the extension. Therefore, this participant was excluded from the analysis. | Posted | Number | Participants | Baseline to 12 months |
|
|
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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 100 mg | Participants were down-titrated to 100 mg. | 1 | 12 | 6 | 12 | ||
| EG001 | LCZ696 200 mg | Participants received LCZ696 200 mg by mouth once daily (qd). | 10 | 340 | 77 | 340 | ||
| EG002 | LCZ696 400 mg | Participants received LCZ696 400 mg by mouth qd. | 2 | 201 | 39 | 201 | ||
| EG003 | LCZ696 400 mg/Aml | Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn. | 0 | 112 | 32 | 112 | ||
| EG004 | LCZ696 400 mg/Aml/HCTZ | Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn. | 0 | 4 | 0 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | 14.1 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | 14.1 | Systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | 14.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | 14.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | 14.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 14.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | 14.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 14.1 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | 14.1 | Systematic Assessment |
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| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 14.1 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | 14.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | 14.1 | Systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
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| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | 14.1 | Systematic Assessment |
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| Gastric ulcer | Gastrointestinal disorders | 14.1 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | 14.1 | Systematic Assessment |
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| Gastritis erosive | Gastrointestinal disorders | 14.1 | Systematic Assessment |
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| Gingivitis | Gastrointestinal disorders | 14.1 | Systematic Assessment |
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| Oesophagitis | Gastrointestinal disorders | 14.1 | Systematic Assessment |
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| Peptic ulcer | Gastrointestinal disorders | 14.1 | Systematic Assessment |
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| Radicular cyst | Gastrointestinal disorders | 14.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | 14.1 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | 14.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | 14.1 | Systematic Assessment |
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| Vestibular neuronitis | Infections and infestations | 14.1 | Systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | 14.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | 14.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | 14.1 | Systematic Assessment |
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| Headache | Nervous system disorders | 14.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | 14.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | 14.1 | Systematic Assessment |
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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 (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
| D017311 | Amlodipine |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Protocol deviation |
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| Lost to Follow-up |
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| Withdrawal by Subject |
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| Lack of Efficacy |
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| Male |
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| Seroius adverse events |
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| Deaths |
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Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn. |
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