Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the effect of LCZ696 and valsartan on natriuresis, diuresis, and blood pressure in salt-sensitive Asian hypertensive patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCZ696 followed by Valsartan | Experimental | Period 1: LCZ696 400mg QD for 4 weeks then washout followed by Period 2: Valsartan 320mg QD for 4 weeks |
|
| Valsartan followed by LCZ696 | Experimental | Period 1: Valsartan 320mg QD for 4 weeks then washout followed by Period 2: LCZ696 400mg QD for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valsartan | Drug | Valsartan 320mg tablet once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Sodium Excretion (Natriuresis) at Day 1 | Urine will be collected in fractions of 6 to 24 hours post-dose. From each fraction, a sample will be drawn for analysis of sodium Day 1 | 0-6 and 0-24 hours on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Sodium Excretion (Natriuresis) at Day 28 | Urine will be collected in fractions of 6 to 24 hours post-dose. From each fraction, a sample will be drawn for analysis of sodium Day 28 | 0-6 and 0-24 hours on Day 28 |
| Urine Volume (Diuresis) Over Time |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Anaheim | California | 92801 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27849566 | Derived | Wang TD, Tan RS, Lee HY, Ihm SH, Rhee MY, Tomlinson B, Pal P, Yang F, Hirschhorn E, Prescott MF, Hinder M, Langenickel TH. Effects of Sacubitril/Valsartan (LCZ696) on Natriuresis, Diuresis, Blood Pressures, and NT-proBNP in Salt-Sensitive Hypertension. Hypertension. 2017 Jan;69(1):32-41. doi: 10.1161/HYPERTENSIONAHA.116.08484. Epub 2016 Nov 14. |
Not provided
Not provided
Not provided
Period 1: 4 weeks treatment with LCZ696 400mg QD or Valsartan 320mg, 1-2 weeks wash-out, followed by period 2, 4 weeks treatment with Valsartan 320mg QD or LCZ696 400mg QD
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | LCZ696 Followed by Valsartan | Period 1: LCZ696 400mg QD for 4 weeks then washout followed by Period 2: Valsartan 320mg QD for 4 weeks |
| FG001 | Valsartan Followed by LCZ696 | Period 1: Valsartan 320mg QD for 4 weeks then washout followed by Period 2: LCZ696 400mg QD for 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| LCZ696 | Drug | LCZ696 400mg tablet once daily |
|
Urine will be collected and volume measured in fractions of 0 to 6 hours and 0 to 24 hours Day-1, Day 1 and Day 28 |
| Day -1, Day 1 & Day 28 |
| Seated Office Blood Pressure (BP) (Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)) Over Time | Seated Office BP (systolic blood pressure (SBP) and diastolic blood pressure (DBP))measurements will be performed at trough(immediately prior to dosing at the clinic). Arterial BP readings will be made with an automated BP device. | Day-1, Day 14 and Day 28 |
| Mean Sitting Pulse Pressure (PP) Over Time | Sitting mean pulse pressure rate was calculated between ambulatory SBP and DBP measurements | Day-1, Day 14 and Day 28 |
| Cypress |
| California |
| 90630 |
| United States |
| Novartis Investigative Site | Glendale | California | 91206 | United States |
| Novartis Investigative Site | Hong Kong | Shatin, NT | Hong Kong |
| Novartis Investigative Site | Singapore | Singapore | 119228 | Singapore |
| Novartis Investigative Site | Singapore | Singapore | 169609 | Singapore |
| Novartis Investigative Site | Bucheon-si | Gyeonggi-do | 424-717 | South Korea |
| Novartis Investigative Site | Koyang-si | Gyeonggi-do | 410-773 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 110 744 | South Korea |
| Novartis Investigative Site | Seoul | 120-752 | 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 | 114 | Taiwan |
| Novartis Investigative Site | Taipei | Taiwan, ROC | 112 | Taiwan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period 2 |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LCZ696 Followed by Valsartan | Period 1: LCZ696 400mg QD for 4 weeks then washout followed by Period 2: Valsartan 320mg QD for 4 weeks |
| BG001 | Valsartan 320mg | Period 1: 4 weeks treatment with Valsartan 320mg QD, 1-2 weeks wash-out, followed by period 2, 4 weeks treatment with LCZ696 400mg QD |
| BG002 | 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 | Cumulative Sodium Excretion (Natriuresis) at Day 1 | Urine will be collected in fractions of 6 to 24 hours post-dose. From each fraction, a sample will be drawn for analysis of sodium Day 1 | Pharmacodynamic PD analysis set: Patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. | Posted | Mean | Standard Deviation | mmol | 0-6 and 0-24 hours on Day 1 |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Cumulative Sodium Excretion (Natriuresis) at Day 28 | Urine will be collected in fractions of 6 to 24 hours post-dose. From each fraction, a sample will be drawn for analysis of sodium Day 28 | Pharmacodynamic PD analysis set: Patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. | Posted | Mean | Standard Deviation | mmol | 0-6 and 0-24 hours on Day 28 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Urine Volume (Diuresis) Over Time | Urine will be collected and volume measured in fractions of 0 to 6 hours and 0 to 24 hours Day-1, Day 1 and Day 28 | Pharmacodynamic PD analysis set: Patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. | Posted | Mean | Standard Deviation | mL | Day -1, Day 1 & Day 28 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Seated Office Blood Pressure (BP) (Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)) Over Time | Seated Office BP (systolic blood pressure (SBP) and diastolic blood pressure (DBP))measurements will be performed at trough(immediately prior to dosing at the clinic). Arterial BP readings will be made with an automated BP device. | Pharmacodynamic PD analysis set: Patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. | Posted | Mean | Standard Deviation | mmHg | Day-1, Day 14 and Day 28 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Mean Sitting Pulse Pressure (PP) Over Time | Sitting mean pulse pressure rate was calculated between ambulatory SBP and DBP measurements | Pharmacodynamic PD analysis set: Patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. | Posted | Mean | Standard Deviation | mmHg | Day-1, Day 14 and Day 28 |
|
|
Not provided
Overall, 72 patients with salt-sensitive hypertension were randomized to one of the two crossover treatment arms. For the Safety Set: overall, 71 patients were exposed to at least one dose of LCZ696 400 mg and a total of 67 patients were exposed to at least one dose of valsartan 320 mg.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LCZ696 400 mg QD | LCZ696 400 mg QD | 0 | 71 | 15 | 71 | ||
| EG001 | Valsartan 320 mg QD | Valsartan 320 mg QD | 0 | 67 | 15 | 67 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DRY MOUTH | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| PYURIA | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis | 862-778-8300 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068756 | Valsartan |
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
Not provided
Not provided
| Male |
|
|
|
|
|