Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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Not provided
Assess mechanism of action of LCZ696 related to sodium excretion.
Not provided
Not provided
Not provided
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Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCZ696 to Valsartan - Heart Failure (HF) cohort | Experimental | Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2. |
|
| Valsartan to LCZ696 - HF Cohort | Experimental | Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2. |
|
| LCZ696 to Valsartan - Hypertension (HTN) cohort | Experimental | Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2. |
|
| Valsartan to LCZ696 - HTN cohort | Experimental | Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCZ696 | Drug | 200 mg and 400 mg tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour Urinary Sodium Excretion | Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, sodium concentration was measured. The measure type used for this outcome measure (OM) was Geometric Least square Means (LSM). | day 1 |
| Cumulative 7-day Urinary Sodium Excretion | Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, sodium concentration was measured. The measure type used for this outcome measure (OM) was Geometric Least square Means (LSM). | 7 day-cummulative (days 1 through 7) |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour Diuresis | Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, urine volume was measured. The measure type used for this OM was Geometric LSM. | day 1 |
| 7-day Cumulative Diuresis |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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 | Moscow | 117198 | Russia |
Not provided
In each of the HF and HTN cohorts, 16 participants (total = 32) received LCZ696 or Valsartan in period 1. Then, there was a cross-over where participants received LCZ96 or Valsartan in period 2.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | LCZ696 to Valsartan - Heart Failure (HF) Cohort | Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2. |
| FG001 | Valsartan to LCZ696 - HF Cohort | Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2. |
| FG002 | LCZ696 to Valsartan - Hypertension (HTN) Cohort | Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2. |
| FG003 | Valsartan to LCZ696 - HTN Cohort | Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 - First Intervention (7 Days) |
|
| ||||||||||||||||||
| Period 2 - Second Intervention (7 Days) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LCZ696 to Valsartan - Heart Failure (HF) Cohort | Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age mean and standard deviation (SD) for HF cohort was 65.4 (9.57); age mean and SD for HTN cohort was 58.8 (8.15) |
| 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 | 24-hour Urinary Sodium Excretion | Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, sodium concentration was measured. The measure type used for this outcome measure (OM) was Geometric Least square Means (LSM). | The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | mmol/24 hours | day 1 |
|
Not provided
Not provided
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 - Heart Failure (HF) Cohort | Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
Regarding LSM = 1218.56 for LCZ696 HTN cohort arm at Day 1, 1.0 hr post dose, the value was heavily inflated due to one participant with a very high change from baseline.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis | 862-778-1873 |
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Valsartan | Drug | 160 mg tablets |
|
Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, urine volume was measured. The measure type used for this OM was Geometric LSM.
| 7-day cumulative (days 1 through 7) |
| Urinary Cyclic Guanosine Monophosphate (cGMP) Excretion Over 24 Hours | cGMP was analyzed at a central laboratory. The measure type used for this OM was Geometric LSM. | day 1, day 6, day 7 |
| Percent Change From Baseline in Plasma Mid-regional Pro-atrial Natriuretic Peptide (MR-proANP) Biomarker | MR-proANP was analyzed at a central laboratory. | 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 2, 4, 6 and 12 hours post dose on day 7 |
| Percent Change From Baseline in Brain Natriuretic Peptide (BNP) Biomarker | BNP was analyzed at a central laboratory. | 0.5, 1, 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7 |
| Percent Change From Baseline in Mid-regional Pro-adrenomedullin (MR-proADM) Biomarker | MR-proADM was analyzed at a central laboratory. | 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7 |
| Percent Change From Baseline in C-type Natriuretic Peptide (proCNP) Biomarker | ProCNP was analyzed at a central laboratory. | 2, 4, 6, 8 and 12 hours post dose on day 1; day 2; 0, 4, 6, 8 and 12 hours post dose on day 7 |
| Percent Change From Baseline in C-terminal-proendothelin-1 (CT-proET-1) Biomarker | CT-proET-1 was analyzed at a central laboratory. | 12 hours post dose on day 1; 24 hours post dose on day 2; 0 and 12 hours post dose on day 7 |
| Percent Change From Baseline in N-terminal-proBNP (NT-proBNP) Biomarker | NT-proBNP was analyzed at a central laboratory. | 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7 |
| Percent Change From Baseline in Aldosterone Biomarker | Aldosterone was analyzed at a central laboratory. | 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 6 and 12 hours post dose on day 7 |
| Percent Change From Baseline in Urinary Electrolyte Excretion (Sodium, Potassium, Chloride and Calcium) | Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, sodium, potassium, albumin and calcium were measured. | 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7 |
| Percent Change From Baseline in Blood Plasma Creatinine | Blood plasma creatinine was analyzed at a central laboratory. | 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7 |
| Glomerular Filtration Rate (GFR) Over Time | GFR was used as a measure of renal function. | 0, 2, 4 and 6 hours post dose on day 1; 0, 2, 4 and 6 hours post dose on day 7 |
| Renal Blood Flow (RBF) Over Time | RBF was used as a measure of renal function. | 0, 2, 4 and 6 hours post dose on day 1; 0, 2, 4 and 6 hours post dose on day 7 |
| Supine Systolic Blood Pressure | Systolic blood pressure measurements were taken. | 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 1; day 2; 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 7 |
| Supine Diastolic Blood Pressure | Diastolic blood pressure measurements were taken. | 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 1; day 2; 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 7 |
| Supine Pulse Rate | Pulse rate measurements were taken. | 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 1; day 2; 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 7 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Valsartan to LCZ696 - HF Cohort |
Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2. |
| BG002 | LCZ696 to Valsartan - Hypertension (HTN) Cohort | Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2. |
| BG003 | Valsartan to LCZ696 - HTN Cohort | Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Valsartan - HF Cohort |
Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2. |
| OG002 | LCZ696 - Hypertension (HTN) Cohort | Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2. |
| OG003 | Valsartan - HTN Cohort | Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2. |
|
|
| Primary | Cumulative 7-day Urinary Sodium Excretion | Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, sodium concentration was measured. The measure type used for this outcome measure (OM) was Geometric Least square Means (LSM). | The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | mmol/7 days | 7 day-cummulative (days 1 through 7) |
|
|
|
| Secondary | 24-hour Diuresis | Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, urine volume was measured. The measure type used for this OM was Geometric LSM. | The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | mL/24 hours | day 1 |
|
|
|
| Secondary | 7-day Cumulative Diuresis | Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, urine volume was measured. The measure type used for this OM was Geometric LSM. | The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | mL | 7-day cumulative (days 1 through 7) |
|
|
|
| Secondary | Urinary Cyclic Guanosine Monophosphate (cGMP) Excretion Over 24 Hours | cGMP was analyzed at a central laboratory. The measure type used for this OM was Geometric LSM. | The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | nmol/24 hours | day 1, day 6, day 7 |
|
|
|
| Secondary | Percent Change From Baseline in Plasma Mid-regional Pro-atrial Natriuretic Peptide (MR-proANP) Biomarker | MR-proANP was analyzed at a central laboratory. | The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change | 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 2, 4, 6 and 12 hours post dose on day 7 |
|
|
|
| Secondary | Percent Change From Baseline in Brain Natriuretic Peptide (BNP) Biomarker | BNP was analyzed at a central laboratory. | The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change | 0.5, 1, 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7 |
|
|
|
| Secondary | Percent Change From Baseline in Mid-regional Pro-adrenomedullin (MR-proADM) Biomarker | MR-proADM was analyzed at a central laboratory. | The HF arms only of the Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis. MR-proADM is considered a biomarker for HF only; therefore, the HTN cohort was not assessed. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change | 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7 |
|
|
|
| Secondary | Percent Change From Baseline in C-type Natriuretic Peptide (proCNP) Biomarker | ProCNP was analyzed at a central laboratory. | The HF arms only of the Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis. MR-proADM is considered a biomarker for HF only; therefore, the HTN cohort was not assessed. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change | 2, 4, 6, 8 and 12 hours post dose on day 1; day 2; 0, 4, 6, 8 and 12 hours post dose on day 7 |
|
|
|
| Secondary | Percent Change From Baseline in C-terminal-proendothelin-1 (CT-proET-1) Biomarker | CT-proET-1 was analyzed at a central laboratory. | The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change | 12 hours post dose on day 1; 24 hours post dose on day 2; 0 and 12 hours post dose on day 7 |
|
|
|
| Secondary | Percent Change From Baseline in N-terminal-proBNP (NT-proBNP) Biomarker | NT-proBNP was analyzed at a central laboratory. | The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change | 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7 |
|
|
|
| Secondary | Percent Change From Baseline in Aldosterone Biomarker | Aldosterone was analyzed at a central laboratory. | The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change | 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 6 and 12 hours post dose on day 7 |
|
|
|
| Secondary | Percent Change From Baseline in Urinary Electrolyte Excretion (Sodium, Potassium, Chloride and Calcium) | Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, sodium, potassium, albumin and calcium were measured. | The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change | 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7 |
|
|
|
| Secondary | Percent Change From Baseline in Blood Plasma Creatinine | Blood plasma creatinine was analyzed at a central laboratory. | The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change | 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7 |
|
|
|
| Secondary | Glomerular Filtration Rate (GFR) Over Time | GFR was used as a measure of renal function. | The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis. | Posted | Mean | Standard Deviation | mL/min | 0, 2, 4 and 6 hours post dose on day 1; 0, 2, 4 and 6 hours post dose on day 7 |
|
|
|
| Secondary | Renal Blood Flow (RBF) Over Time | RBF was used as a measure of renal function. | The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis. | Posted | Mean | Standard Deviation | mL/min | 0, 2, 4 and 6 hours post dose on day 1; 0, 2, 4 and 6 hours post dose on day 7 |
|
|
|
| Secondary | Supine Systolic Blood Pressure | Systolic blood pressure measurements were taken. | The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis. | Posted | Mean | Standard Deviation | mmHg | 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 1; day 2; 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 7 |
|
|
|
| Secondary | Supine Diastolic Blood Pressure | Diastolic blood pressure measurements were taken. | The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis. | Posted | Mean | Standard Deviation | mmHg | 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 1; day 2; 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 7 |
|
|
|
| Secondary | Supine Pulse Rate | Pulse rate measurements were taken. | The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis. | Posted | Mean | Standard Deviation | BPM | 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 1; day 2; 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 7 |
|
|
|
| 0 |
| 16 |
| 3 |
| 16 |
| EG001 | Valsartan - HF Cohort | Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2. | 0 | 15 | 1 | 15 |
| EG002 | LCZ696 - Hypertension (HTN) Cohort | Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2. | 0 | 15 | 1 | 15 |
| EG003 | Valsartan - HTN Cohort | Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2. | 0 | 16 | 3 | 16 |
| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dysuria | Renal and urinary 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.
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| Day 6 |
|
| Day 7 |
|
| Day 1, 4.0 hrs post dose |
|
| Day 1, 6.0 hours post dose |
|
| Day 1, 12.0 hrs post dose |
|
| Day 2, 24.0 hrs post dose |
|
| Day 7, 0.0 hours |
|
| Day 7, 4.0 hours post dose |
|
| Day 7, 6.0 hours post dose |
|
| Day 7, 12.0 hours post dose |
|
| Day 1, 1.0 hr post dose |
|
| Day 1, 2.0 hours post dose |
|
| Day 1, 4.0 hrs post dose |
|
| Day 1, 6.0 hrs post dose |
|
| Day 1, 12.0 hrs post dose |
|
| Day 2, 24 hrs post dose |
|
| Day 7, 0.0 hr |
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| Day 7, 4.0 hrs post dose |
|
| Day 7, 6.0 hrs post dose |
|
| Day 7, 12.0 hrs post dose |
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| Day 1, 6.0 hrs post dose |
|
| Day 1, 12.0 hrs post dose |
|
| Day 2, 24 hrs post dose |
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| Day 7, 0.0 hrs |
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| Day 7, 4.0 hrs post dose |
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| Day 7, 6.0 hrs post dose |
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| Day 7, 12.0 hrs post dose |
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| Day 1, 6.0 hrs post dose |
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| Day 1, 8.0 hrs post dose |
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| Day 1, 12.0 hrs post dose |
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| Day 2, 24 hrs post dose |
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| Day 7, 0.0 hour |
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| Day 7, 4.0 hours post dose |
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| Day 7, 6.0 hrs post dose |
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| Day 7, 8.0 hrs post dose |
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| Day 7, 12.0 hrs post dose |
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| Day 2, 24.0 hours post dose |
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| Day 7, 0.0 hour |
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| Day 7, 12.0 hours post dose |
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| Day 1, 4.0 hours post dose |
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| Day 1, 6.0 hours post dose |
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| Day 1, 12.0 hours post dose |
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| Day 2, 24 hours post dose |
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| Day 7, 0.0 hour |
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| Day 7, 4.0 hours post dose |
|
| Day 7, 6.0 hours post dose |
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| Day 7, 12.0 hours post dose |
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| Day 1, 12.0 hours post dose |
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| Day 2, 24.0 hours post dose |
|
| Day 7, 0.0 hour |
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| Day 7, 6.0 hours post dose |
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| Day 7, 12.0 hours post dose |
|
| Calcium, day 1, 4.0 hours post dose |
|
| Calcium, day 1, 6.0 hours post dose |
|
| Calcium, day 1, 12.0 hours post dose |
|
| Calcium, day 2, 24 hours post dose |
|
| Calcium, day 7, 0.0 hour |
|
| Calcium, day 7, 4.0 hours post dose |
|
| Calcium, day 7, 6.0 hours post dose |
|
| Calcium, day 7, 12.0 hours post dose |
|
| Chloride, day 1, 2.0 hours post dose |
|
| Chloride, day 1, 4.0 hours post dose |
|
| Chloride, day 1, 6.0 hours post dose |
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| Chloride, day 1, 12.0 hours post dose |
|
| Chloride, day 2, 24 hours post dose |
|
| Chloride, day 7, 0.0 hour |
|
| Chloride, day 7, 4.0 hours post dose |
|
| Chloride, day 7, 6.0 hours post dose |
|
| Chloride, day 7, 12.0 hours post dose |
|
| Potassium, day 1, 2.0 hours post dose |
|
| Potassium, day 1, 4.0 hours post dose |
|
| Potassium, day 1, 6.0 hours post dose |
|
| Potassium, day 1, 12.0 hours post dose |
|
| Potassium, day 2, 24.0 hours post dose |
|
| Potassium, day 7, 0.0 hour |
|
| Potassium, day 7, 4.0 hours post dose |
|
| Potassium, day 7, 6.0 hours post dose |
|
| Potassium, day 7, 12.0 hours post dose |
|
| Sodium, day 1, 2.0 hours post dose |
|
| Sodium, day 1, 4.0 hours post dose |
|
| Sodium, day 1, 6.0 hours post dose |
|
| Sodium, day 1, 12.0 hours post dose |
|
| Sodium, day 2, 24.0 hours post dose |
|
| Sodium, day 7, 0.0 hour |
|
| Sodium, day 7, 4.0 hours post dose |
|
| Sodium, day 7, 6.0 hours post dose |
|
| Sodium, day 7, 12.0 hours post dose |
|
| Day 1, 6.0 hrs post dose |
|
| Day 1, 12.0 hrs post dose |
|
| Day 2, 24 hrs post dose |
|
| Day 7, 0.0 hour |
|
| Day 7, 4.0 hrs post dose |
|
| Day 7, 6.0 hrs post dose |
|
| Day 7, 12 hrs post dose |
|
| Day 1, 2 hours post dose |
|
| Day 1, 4 hours post dose |
|
| Day 1, 6 hours post dose |
|
| Day 7, 0 hour |
|
| Day 7, 2 hours post dose |
|
| Day 7, 4 hours post dose |
|
| Day 7, 6 hours post dose |
|
| Day 1, 2 hours post dose |
|
| Day 1, 4 hours post dose |
|
| Day 1, 6 hours post dose |
|
| Day 7, 0 hour |
|
| Day 7, 2 hours |
|
| Day 7, 4 hours |
|
| Day 7, 6 hours |
|
| Day 1, 0.5 hour post dose |
|
| Day 1, 1.0 hour post dose |
|
| Day 1, 2.0 hours post dose |
|
| Day 1, 4.0 hours post dose |
|
| Day 1, 8.0 hours post dose |
|
| Day 1, 12.0 hours post dose |
|
| Day 2 |
|
| Day 7, 0.0 hour |
|
| Day 7, 0.5 hour post dose |
|
| Day 7, 1.0 hour post dose |
|
| Day 7, 2.0 hours post dose |
|
| Day 7, 4.0 hours post dose |
|
| Day 7, 8.0 hours post dose |
|
| Day 7, 12.0 hours post dose |
|
| Day 1, 0.5 hour post dose |
|
| Day 1, 1.0 hour post dose |
|
| Day 1, 2.0 hours post dose |
|
| Day 1, 4.0 hours post dose |
|
| Day 1, 8.0 hours post dose |
|
| Day 1, 12.0 hours post dose |
|
| Day 2 |
|
| Day 7, 0.0 hour |
|
| Day 7, 0.5 hour post dose |
|
| Day 7, 1.0 hour post dose |
|
| Day 7, 2.0 hours post dose |
|
| Day 7, 4.0 hours post dose |
|
| Day 7, 8.0 hours post dose |
|
| Day 7, 12.0 hours post dose |
|
| Day 1, 0.5 hour post dose |
|
| Day 1, 1.0 hour post dose |
|
| Day 1, 2.0 hours post dose |
|
| Day 1, 4.0 hours post dose |
|
| Day 1, 8.0 hours post dose |
|
| Day 1, 12.0 hours post dose |
|
| Day 2 |
|
| Day 7, 0.0 hour post dose |
|
| Day 7, 0.5 hour post dose |
|
| Day 7, 1.0 hour post dose |
|
| Day 7, 2.0 hours post dose |
|
| Day 7, 4.0 hours post dose |
|
| Day 7, 8.0 hours post dose |
|
| Day 7, 12.0 hours post dose |
|