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This study assessed the safety, tolerability, and efficacy of LCZ696 in hypertensive patients with renal dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCZ696 100 mg | Experimental | All participants were started on LCZ696 100 mg once daily on day 1. |
|
| LCZ696 200 mg | Experimental | All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg. |
|
| LCZ696 400 mg | Experimental | All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCZ696 | Drug | 100 mg, 200 mg, 400 mg tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Reported Adverse Events (Total Adverse Events, Serious Adverse Events and Death) | Percentage of patients with total adverse events, serious adverse events and death were reported. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 8 | Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurements. | baseline, 8 weeks |
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Sapporo | Hokkaido | 003-0026 | Japan | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25693859 | Background | Ito S, Satoh M, Tamaki Y, Gotou H, Charney A, Okino N, Akahori M, Zhang J. Safety and efficacy of LCZ696, a first-in-class angiotensin receptor neprilysin inhibitor, in Japanese patients with hypertension and renal dysfunction. Hypertens Res. 2015 Apr;38(4):269-75. doi: 10.1038/hr.2015.1. Epub 2015 Feb 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | LCZ696 100 mg | All participants were started on LCZ696 100 mg once daily on day 1. |
| FG001 | LCZ696 200 mg | All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg. |
| FG002 | LCZ696 400 mg | All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LCZ696 100 mg | All participants were started on LCZ696 100 mg once daily on day 1. |
| BG001 | LCZ696 200 mg | All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Participants With Reported Adverse Events (Total Adverse Events, Serious Adverse Events and Death) | Percentage of patients with total adverse events, serious adverse events and death were reported. | Safety Set: This set included all participants who received at least one dose of LCZ696. AE analysis was determined by actual treatment, i.e. the LCZ696 dose on the day in which the corresponding summary was targeting. Other safety analysis was determined by the maximum treatment. | Posted | Number | Percentage of participants | 8 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 | LCZ 100 mg | LCZ 100 mg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SUPRAVENTRICULAR EXTRASYSTOLES | Cardiac disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | +1 (862) 778-8300 |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
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| baseline, 8 weeks |
| Percentage of Participants Achieving a Successful BP Control at Week 8 | A successful BP control was defined as msSBP <130 mmHg and msDBP <80 mmHg | 8 weeks |
| Percentage of Participants Achieving SBP Control at Week 8 | SBP control was defined as msSBP <130 mmHg. | 8 weeks |
| Percentage of Participants Achieving DBP Control at Week 8 | DBP control was defined as msDBP <80 mmHg. | 8 weeks |
| Percentage of Participants Achieving a Successful Response Rate in msSBP at Week 8 | Successful response rate was defined as msSBP <130 mmHg or a reduction of ≥20 mmHg from baseline | 8 weeks |
| Percentage of Participants Achieving a Successful Response Rate in msDBP at Week 8 | Successful response rate was defined as msDBP <80 mmHg or a reduction of ≥10 mmHg from baseline. | 8 weeks |
| Sapporo |
| Hokkaido |
| 003-0825 |
| Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 063-0842 | Japan |
| Novartis Investigative Site | Aira | Kagoshima-ken | 899-5431 | Japan |
| Novartis Investigative Site | Kawasaki | Kanagawa | 210-0852 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 231-0023 | Japan |
| Novartis Investigative Site | Sendai | Miyagi | 980-8574 | Japan |
| Novartis Investigative Site | Kurashiki | Okayama-ken | 701-0192 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 536-0008 | Japan |
| Novartis Investigative Site | Fujimino | Saitama | 356-0053 | Japan |
| Novartis Investigative Site | Hachiōji | Tokyo | 192-0918 | Japan |
| Novartis Investigative Site | Minato-ku | Tokyo | 108-0075 | Japan |
| Novartis Investigative Site | Shinagawa-ku | Tokyo | 141-0032 | Japan |
| BG002 | LCZ696 400 mg | All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
| OG002 | LCZ696 400 mg | All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg. |
| OG003 | Total LCZ696 | All participants who received LCZ696 |
|
|
| Secondary | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 8 | Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurements. | Full Analysis Set (FAS): This set included all participants who entered the treatment epoch. Patients who were not qualified to enter the treatment epoch were excluded from the FAS provided those participants did not receive LCZ696. | Posted | Mean | Standard Deviation | mmHg | baseline, 8 weeks |
|
|
|
| Secondary | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 8 | FAS | Posted | Mean | Standard Deviation | mmHg | baseline, 8 weeks |
|
|
|
| Secondary | Percentage of Participants Achieving a Successful BP Control at Week 8 | A successful BP control was defined as msSBP <130 mmHg and msDBP <80 mmHg | FAS | Posted | Number | Percentage of Participants | 8 weeks |
|
|
|
| Secondary | Percentage of Participants Achieving SBP Control at Week 8 | SBP control was defined as msSBP <130 mmHg. | FAS | Posted | Number | Percentage of participants | 8 weeks |
|
|
|
| Secondary | Percentage of Participants Achieving DBP Control at Week 8 | DBP control was defined as msDBP <80 mmHg. | FAS | Posted | Number | Percentage of participants | 8 weeks |
|
|
|
| Secondary | Percentage of Participants Achieving a Successful Response Rate in msSBP at Week 8 | Successful response rate was defined as msSBP <130 mmHg or a reduction of ≥20 mmHg from baseline | FAS | Posted | Number | Percentage of participants | 8 weeks |
|
|
|
| Secondary | Percentage of Participants Achieving a Successful Response Rate in msDBP at Week 8 | Successful response rate was defined as msDBP <80 mmHg or a reduction of ≥10 mmHg from baseline. | FAS | Posted | Number | Percentage of participants | 8 weeks |
|
|
|
| 0 |
| 32 |
| 5 |
| 32 |
| EG001 | LCZ 400 mg | LCZ 400 mg | 0 | 18 | 5 | 18 |
| EG002 | Total LCZ696 | All participants who received LCZ696 | 0 | 32 | 9 | 32 |
| EG003 | LCZ 200 mg | LCZ 200 mg | 0 | 26 | 0 | 26 |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| TOOTHACHE | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA | 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 (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |