CClinicalTrials.gg
Sign In
CompletedNCT01353508Updated Nov 23, 2015Results posted

Sodium Excretion of LCZ696 in Patients With Hypertension; Heart Failure and Healthy Volunteers

A Phase 2 interventional study of LCZ696 and Valsartan in Hypertension, sponsored by Novartis Pharmaceuticals. Completed at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-23.

Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Assess mechanism of action of LCZ696 related to sodium excretion.

02

Conditions studied

  • Hypertension

Keywords

  • Sodium excretion,
  • LCZ696
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 32 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with heart failure: documented NYHA class II-III heart failure
  • Patients with hypertension: stable hypertensive medication for the preceding 2 months

Exclusion criteria

Exclusion Criteria:

  • Women of childbearing potential
  • History of recent myocardial infarction
  • History of dialysis or renal transplant
  • Patients with type 1 diabetes mellitus
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    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.

    Drug: LCZ696 · Drug: Valsartan

  • Experimental
    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.

    Drug: LCZ696 · Drug: Valsartan

  • Experimental
    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.

    Drug: LCZ696 · Drug: Valsartan

  • Experimental
    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.

    Drug: LCZ696 · Drug: Valsartan

Interventions

  • DrugLCZ696

    200 mg and 400 mg tablets

  • DrugValsartan

    160 mg tablets

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: day 1

  2. 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).

    Time frame: 7 day-cummulative (days 1 through 7)

Secondary outcomes

  1. 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.

    Time frame: day 1

  2. 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.

    Time frame: 7-day cumulative (days 1 through 7)

  3. 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.

    Time frame: day 1, day 6, day 7

  4. Percent Change From Baseline in Plasma Mid-regional Pro-atrial Natriuretic Peptide (MR-proANP) Biomarker

    MR-proANP was analyzed at a central laboratory.

    Time frame: 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

  5. Percent Change From Baseline in Brain Natriuretic Peptide (BNP) Biomarker

    BNP was analyzed at a central laboratory.

    Time frame: 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

  6. Percent Change From Baseline in Mid-regional Pro-adrenomedullin (MR-proADM) Biomarker

    MR-proADM was analyzed at a central laboratory.

    Time frame: 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

  7. Percent Change From Baseline in C-type Natriuretic Peptide (proCNP) Biomarker

    ProCNP was analyzed at a central laboratory.

    Time frame: 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

  8. Percent Change From Baseline in C-terminal-proendothelin-1 (CT-proET-1) Biomarker

    CT-proET-1 was analyzed at a central laboratory.

    Time frame: 12 hours post dose on day 1; 24 hours post dose on day 2; 0 and 12 hours post dose on day 7

  9. Percent Change From Baseline in N-terminal-proBNP (NT-proBNP) Biomarker

    NT-proBNP was analyzed at a central laboratory.

    Time frame: 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

  10. Percent Change From Baseline in Aldosterone Biomarker

    Aldosterone was analyzed at a central laboratory.

    Time frame: 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

  11. 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.

    Time frame: 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

  12. Percent Change From Baseline in Blood Plasma Creatinine

    Blood plasma creatinine was analyzed at a central laboratory.

    Time frame: 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

  13. Glomerular Filtration Rate (GFR) Over Time

    GFR was used as a measure of renal function.

    Time frame: 0, 2, 4 and 6 hours post dose on day 1; 0, 2, 4 and 6 hours post dose on day 7

  14. Renal Blood Flow (RBF) Over Time

    RBF was used as a measure of renal function.

    Time frame: 0, 2, 4 and 6 hours post dose on day 1; 0, 2, 4 and 6 hours post dose on day 7

  15. Supine Systolic Blood Pressure

    Systolic blood pressure measurements were taken.

    Time frame: 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

  16. Supine Diastolic Blood Pressure

    Diastolic blood pressure measurements were taken.

    Time frame: 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

  17. Supine Pulse Rate

    Pulse rate measurements were taken.

    Time frame: 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

07

Results

Posted Nov 23, 2015
Limitations and caveats
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.

Participant flow

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.

Period 1 - First Intervention (7 Days)
Participant flow — Period 1 - First Intervention (7 Days)
MilestoneLCZ696 to Valsartan - Heart Failure (HF) CohortValsartan to LCZ696 - HF CohortLCZ696 to Valsartan - Hypertension (HTN) CohortValsartan to LCZ696 - HTN Cohort
Started8888
Completed8887
Not completed0001
Withdrew: Adverse event0001
Period 2 - Second Intervention (7 Days)
Participant flow — Period 2 - Second Intervention (7 Days)
MilestoneLCZ696 to Valsartan - Heart Failure (HF) CohortValsartan to LCZ696 - HF CohortLCZ696 to Valsartan - Hypertension (HTN) CohortValsartan to LCZ696 - HTN Cohort
Started8887
Completed7887
Not completed1000
Withdrew: Withdrawal by subject1000

Outcome measures

Primary24-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).

Time frame:
day 1
Reported as:
Least squares mean · mmol/24 hours
24-hour Urinary Sodium Excretion
mmol/24 hoursLCZ696 - Heart Failure (HF) CohortValsartan - HF CohortLCZ696 - Hypertension (HTN) CohortValsartan - HTN Cohort
24-hour Urinary Sodium Excretion220.58 (182.64 to 266.41)198.73 (163.50 to 241.56)177.40 (152.65 to 206.15)146.18 (126.42 to 169.03)
PrimaryCumulative 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).

Time frame:
7 day-cummulative (days 1 through 7)
Reported as:
Least squares mean · mmol/7 days
Cumulative 7-day Urinary Sodium Excretion
mmol/7 daysLCZ696 - Heart Failure (HF) CohortValsartan - HF CohortLCZ696 - Hypertension (HTN) CohortValsartan - HTN Cohort
Cumulative 7-day Urinary Sodium Excretion1020.57 (903.47 to 1152.84)1114.18 (983.37 to 1262.39)906.81 (839.94 to 979.00)943.26 (873.62 to 1018.45)
Secondary24-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.

Time frame:
day 1
Reported as:
Least squares mean · mL/24 hours
24-hour Diuresis
mL/24 hoursLCZ696 - Heart Failure (HF) CohortValsartan - HF CohortLCZ696 - Hypertension (HTN) CohortValsartan - HTN Cohort
24-hour Diuresis3199.37 (2662.17 to 3844.96)2874.36 (2375.61 to 3477.82)3382.94 (2859.86 to 4001.70)2393.61 (2034.84 to 2815.64)
Secondary7-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.

Time frame:
7-day cumulative (days 1 through 7)
Reported as:
Least squares mean · mL
7-day Cumulative Diuresis
mLLCZ696 - Heart Failure (HF) CohortValsartan - HF CohortLCZ696 - Hypertension (HTN) CohortValsartan - HTN Cohort
7-day Cumulative Diuresis12347.92 (10842.81 to 14062.48)13180.02 (11539.55 to 15053.71)16980.05 (15627.59 to 18449.54)15265.35 (14048.28 to 16587.87)
SecondaryUrinary 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.

Time frame:
day 1, day 6, day 7
Reported as:
Least squares mean · nmol/24 hours
Urinary Cyclic Guanosine Monophosphate (cGMP) Excretion Over 24 Hours
nmol/24 hoursLCZ696 - Heart Failure (HF) CohortValsartan - HF CohortLCZ696 - Hypertension (HTN) CohortValsartan - HTN Cohort
Day 11851.79 (1504.96 to 2278.56)884.99 (713.93 to 1097.03)1085.76 (867.64 to 1358.71)557.53 (448.87 to 692.51)
Day 61467.67 (1153.25 to 1867.79)865.62 (674.39 to 1111.07)863.32 (707.64 to 1053.25)562.11 (460.85 to 685.63)
Day 71571.02 (1331.84 to 1853.15)859.07 (723.03 to 1020.72)1107.04 (869.95 to 1408.76)603.90 (474.68 to 768.30)
SecondaryPercent Change From Baseline in Plasma Mid-regional Pro-atrial Natriuretic Peptide (MR-proANP) Biomarker

MR-proANP was analyzed at a central laboratory.

Time frame:
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
Reported as:
Least squares mean · Percentage change
Percent Change From Baseline in Plasma Mid-regional Pro-atrial Natriuretic Peptide (MR-proANP) Biomarker
Percentage changeLCZ696 - Heart Failure (HF) CohortValsartan - HF CohortLCZ696 - Hypertension (HTN) CohortValsartan - HTN Cohort
Day 1, 2.0 hours post dose-7.04 (-12.21 to -1.87)2.08 (-3.48 to 7.63)-10.11 (-17.41 to -2.82)-1.66 (-7.99 to 4.68)
Day 1, 4.0 hrs post dose-17.39 (-24.68 to -10.10)-6.74 (-14.32 to 0.84)-12.68 (-25.45 to 0.08)-7.33 (-19.27 to 4.61)
Day 1, 6.0 hours post dose-23.99 (-31.64 to -16.33)-10.16 (-18.08 to -2.23)-17.82 (-25.16 to -10.48)-4.52 (-11.60 to 2.56)
Day 1, 12.0 hrs post dose-27.58 (-38.93 to -16.22)-7.48 (-19.26 to 4.29)-19.77 (-32.56 to -6.98)-15.20 (-27.10 to -3.31)
Day 2, 24.0 hrs post dose-25.13 (-35.53 to -14.73)-14.53 (-25.28 to -3.78)-17.30 (-33.46 to -1.13)-9.45 (-24.39 to 5.50)
Day 7, 0.0 hours-21.27 (-29.72 to -12.81)-2.54 (-11.30 to 6.21)-16.03 (-28.52 to -3.53)0.44 (-11.59 to 12.46)
Day 7, 4.0 hours post dose-24.35 (-35.18 to -13.52)1.64 (-9.62 to 12.91)-19.34 (-31.20 to -7.49)-2.56 (-13.90 to 8.78)
Day 7, 6.0 hours post dose-23.40 (-33.98 to -12.82)-3.53 (-14.54 to 7.48)-20.84 (-33.62 to -8.05)-1.98 (-14.25 to 10.28)
Day 7, 12.0 hours post dose-20.95 (-33.10 to -8.80)-12.65 (-25.27 to -0.03)-23.09 (-35.90 to -10.28)-10.27 (-22.61 to 2.06)
SecondaryPercent Change From Baseline in Brain Natriuretic Peptide (BNP) Biomarker

BNP was analyzed at a central laboratory.

Time frame:
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
Reported as:
Least squares mean · Percentage change
Percent Change From Baseline in Brain Natriuretic Peptide (BNP) Biomarker
Percentage changeLCZ696 - Heart Failure (HF) CohortValsartan - HF CohortLCZ696 - Hypertension (HTN) CohortValsartan - HTN Cohort
Day 1, 0.5 hour post dose72.32 (-70.26 to 214.90)-8.93 (-151.85 to 133.99)-10.75 (-28.59 to 7.08)-5.94 (-23.59 to 11.71)
Day 1, 1.0 hr post dose121.85 (-86.02 to 329.72)-0.83 (-209.19 to 207.53)1218.56 (-760.23 to 3197.35)-33.19 (-1865.92 to 1799.53)
Day 1, 2.0 hours post dose176.35 (-85.34 to 438.04)21.92 (-215.63 to 259.47)31.10 (8.44 to 53.76)-0.38 (-21.37 to 20.61)
Day 1, 4.0 hrs post dose50.12 (30.22 to 70.02)-1.78 (-21.01 to 17.44)38.82 (18.71 to 58.92)11.06 (-7.56 to 29.68)
Day 1, 6.0 hrs post dose130.62 (-10.46 to 271.70)11.09 (-130.33 to 152.51)68.23 (11.48 to 124.97)7.97 (-44.59 to 60.52)
Day 1, 12.0 hrs post dose90.58 (28.51 to 152.66)30.07 (-32.15 to 92.29)85.93 (23.34 to 148.52)8.51 (-48.97 to 65.99)
Day 2, 24 hrs post dose102.88 (-84.18 to 289.93)5.18 (-174.46 to 184.81)-0.66 (-31.34 to 30.02)-20.61 (-47.16 to 5.94)
Day 7, 0.0 hr190.96 (-100.59 to 482.51)27.75 (-264.49 to 320.00)14.20 (-28.81 to 57.21)-7.19 (-48.17 to 33.79)
Day 7, 4.0 hrs post dose220.38 (-72.28 to 513.04)34.44 (-249.44 to 318.31)34.92 (-6.58 to 76.42)5.20 (-34.59 to 44.99)
Day 7, 6.0 hrs post dose195.06 (-94.90 to 485.02)46.75 (-257.14 to 350.63)7.78 (-33.49 to 49.04)7.82 (-29.68 to 45.32)
Day 7, 12.0 hrs post dose236.05 (-173.38 to 645.47)70.31 (-334.37 to 474.99)38.45 (-13.98 to 90.88)25.79 (-24.48 to 76.06)
SecondaryPercent Change From Baseline in Mid-regional Pro-adrenomedullin (MR-proADM) Biomarker

MR-proADM was analyzed at a central laboratory.

Time frame:
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
Reported as:
Least squares mean · Percentage change
Percent Change From Baseline in Mid-regional Pro-adrenomedullin (MR-proADM) Biomarker
Percentage changeLCZ696 - Heart Failure (HF) CohortValsartan - HF Cohort
Day 1, 2.0 hours post dose8.04 (-0.34 to 16.42)-2.87 (-11.53 to 5.79)
Day 1, 4.0 hrs post dose21.22 (11.38 to 31.06)-8.22 (-18.03 to 1.59)
Day 1, 6.0 hrs post dose20.18 (10.05 to 30.31)-8.81 (-18.90 to 1.27)
Day 1, 12.0 hrs post dose40.70 (22.25 to 59.15)7.61 (-10.84 to 26.05)
Day 2, 24 hrs post dose57.28 (42.29 to 72.26)0.72 (-14.26 to 15.70)
Day 7, 0.0 hrs61.28 (47.35 to 75.21)1.38 (-12.07 to 14.83)
Day 7, 4.0 hrs post dose51.71 (39.67 to 63.74)-5.27 (-16.90 to 6.36)
Day 7, 6.0 hrs post dose48.22 (36.26 to 60.19)-3.63 (-14.89 to 7.64)
Day 7, 12.0 hrs post dose69.45 (50.70 to 88.20)2.15 (-16.60 to 20.90)
SecondaryPercent Change From Baseline in C-type Natriuretic Peptide (proCNP) Biomarker

ProCNP was analyzed at a central laboratory.

Time frame:
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
Reported as:
Least squares mean · Percentage change
Percent Change From Baseline in C-type Natriuretic Peptide (proCNP) Biomarker
Percentage changeLCZ696 - Heart Failure (HF) CohortValsartan - HF Cohort
Day 1, 2.0 hrs post dose0.35 (-6.33 to 7.03)-1.01 (-8.16 to 6.13)
Day 1, 4.0 hours post dose34.58 (19.36 to 49.79)-6.02 (-22.28 to 10.25)
Day 1, 6.0 hrs post dose67.85 (42.32 to 93.37)-16.19 (-43.85 to 11.48)
Day 1, 8.0 hrs post dose123.75 (87.53 to 159.98)-9.87 (-48.59 to 28.86)
Day 1, 12.0 hrs post dose190.36 (148.95 to 231.78)15.55 (-29.00 to 60.09)
Day 2, 24 hrs post dose218.81 (163.62 to 274.01)4.99 (-54.79 to 64.78)
Day 7, 0.0 hour244.20 (186.26 to 302.14)0.09 (-61.85 to 62.04)
Day 7, 4.0 hours post dose216.61 (159.66 to 273.56)-8.94 (-69.82 to 51.95)
Day 7, 6.0 hrs post dose211.21 (151.36 to 271.07)-18.17 (-82.15 to 45.82)
Day 7, 8.0 hrs post dose241.99 (181.22 to 302.76)-11.30 (-76.27 to 53.67)
Day 7, 12.0 hrs post dose278.58 (214.45 to 342.71)0.88 (-67.68 to 69.44)
SecondaryPercent Change From Baseline in C-terminal-proendothelin-1 (CT-proET-1) Biomarker

CT-proET-1 was analyzed at a central laboratory.

Time frame:
12 hours post dose on day 1; 24 hours post dose on day 2; 0 and 12 hours post dose on day 7
Reported as:
Least squares mean · Percentage change
Percent Change From Baseline in C-terminal-proendothelin-1 (CT-proET-1) Biomarker
Percentage changeLCZ696 - Heart Failure (HF) CohortValsartan - HF CohortLCZ696 - Hypertension (HTN) CohortValsartan - HTN Cohort
Day 1, 12.0 hours post dose36.39 (26.14 to 46.65)2.51 (-8.14 to 13.16)108.87 (5.82 to 211.92)54.07 (-38.42 to 146.57)
Day 2, 24.0 hours post dose32.44 (19.41 to 45.47)11.41 (-2.76 to 25.59)123.45 (36.65 to 210.25)38.70 (-41.78 to 119.19)
Day 7, 0.0 hour31.98 (19.53 to 44.42)0.62 (-11.85 to 13.09)94.76 (17.45 to 172.06)41.77 (-32.97 to 116.50)
Day 7, 12.0 hours post dose41.75 (26.81 to 56.69)7.05 (-8.97 to 23.08)117.84 (30.76 to 204.92)61.90 (-22.40 to 146.20)
SecondaryPercent Change From Baseline in N-terminal-proBNP (NT-proBNP) Biomarker

NT-proBNP was analyzed at a central laboratory.

Time frame:
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
Reported as:
Least squares mean · Percentage change
Percent Change From Baseline in N-terminal-proBNP (NT-proBNP) Biomarker
Percentage changeLCZ696 - Heart Failure (HF) CohortValsartan - HF CohortLCZ696 - Hypertension (HTN) CohortValsartan - HTN Cohort
Day 1, 2.0 hours post dose3.06 (-1.80 to 7.92)6.87 (1.87 to 11.88)5.10 (-1.10 to 11.31)8.32 (2.32 to 14.32)
Day 1, 4.0 hours post dose2.68 (-5.30 to 10.66)13.21 (5.02 to 21.40)44.79 (-11.93 to 101.51)22.14 (-32.65 to 76.93)
Day 1, 6.0 hours post dose3.71 (-8.15 to 15.57)21.70 (9.59 to 33.80)12.58 (-4.17 to 29.33)21.21 (5.03 to 37.39)
Day 1, 12.0 hours post dose17.15 (-3.58 to 37.89)42.32 (20.94 to 63.70)61.46 (3.83 to 119.09)33.17 (-22.28 to 88.62)
Day 2, 24 hours post dose-21.85 (-35.37 to -8.33)23.51 (9.48 to 37.54)8.61 (-20.73 to 37.95)-4.41 (-32.64 to 23.81)
Day 7, 0.0 hour-19.57 (-34.08 to -5.05)2.29 (-12.74 to 17.32)-10.14 (-35.77 to 15.48)-0.13 (-25.77 to 25.51)
Day 7, 4.0 hours post dose-14.60 (-30.67 to 1.47)14.85 (-1.78 to 31.49)-8.10 (-35.21 to 19.01)19.83 (-7.29 to 46.95)
Day 7, 6.0 hours post dose-15.05 (-32.53 to 2.43)17.34 (-0.75 to 35.44)-9.42 (-37.40 to 18.57)20.47 (-6.63 to 47.58)
Day 7, 12.0 hours post dose1.37 (-22.83 to 25.56)46.05 (20.87 to 71.22)12.22 (-26.18 to 50.62)47.27 (8.85 to 85.68)
SecondaryPercent Change From Baseline in Aldosterone Biomarker

Aldosterone was analyzed at a central laboratory.

Time frame:
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
Reported as:
Least squares mean · Percentage change
Percent Change From Baseline in Aldosterone Biomarker
Percentage changeLCZ696 - Heart Failure (HF) CohortValsartan - HF CohortLCZ696 - Hypertension (HTN) CohortValsartan - HTN Cohort
Day 1, 6.0 hours post dose71.15 (29.66 to 112.64)-14.63 (-56.02 to 26.77)90.51 (-39.10 to 220.12)72.92 (-48.38 to 194.22)
Day 1, 12.0 hours post dose208.06 (44.03 to 372.10)8.36 (-155.05 to 171.77)249.13 (4.30 to 493.96)325.31 (96.75 to 553.86)
Day 2, 24.0 hours post dose168.32 (65.01 to 271.63)71.73 (-35.08 to 178.55)438.28 (-67.61 to 944.17)524.93 (55.45 to 994.41)
Day 7, 0.0 hour111.21 (16.31 to 206.11)21.68 (-77.33 to 120.69)49.91 (-12.58 to 112.40)5.61 (-55.0 to 66.22)
Day 7, 6.0 hours post dose65.22 (7.48 to 122.95)24.58 (-31.70 to 80.87)24.47 (-104.07 to 153.01)107.60 (-16.47 to 231.67)
Day 7, 12.0 hours post dose238.32 (-46.10 to 522.74)230.06 (-58.04 to 518.17)147.89 (-4.40 to 300.19)152.37 (4.74 to 300.00)
SecondaryPercent 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.

Time frame:
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
Reported as:
Least squares mean · Percentage change
Percent Change From Baseline in Urinary Electrolyte Excretion (Sodium, Potassium, Chloride and Calcium)
Percentage changeLCZ696 - Heart Failure (HF) CohortValsartan - HF CohortLCZ696 - Hypertension (HTN) CohortValsartan - HTN Cohort
Calcium, day 1, 2.0 hours post dose-0.05 (-1.24 to 1.13)-1.40 (-2.62 to -0.17)0.51 (-1.00 to 2.01)0.08 (-1.38 to 1.53)
Calcium, day 1, 4.0 hours post dose-2.19 (-3.78 to -0.60)-2.46 (-4.11 to -0.81)0.76 (-1.39 to 2.91)0.27 (-1.79 to 2.33)
Calcium, day 1, 6.0 hours post dose-3.69 (-5.19 to -2.19)-4.03 (-5.59 to -2.48)-2.22 (-3.89 to -0.55)-2.49 (-4.10 to -0.89)
Calcium, day 1, 12.0 hours post dose-2.80 (-4.24 to -1.37)-1.34 (-2.83 to 0.16)1.77 (-0.40 to 3.94)0.82 (-1.27 to 2.91)
Calcium, day 2, 24 hours post dose-2.09 (-4.21 to 0.02)0.44 (-1.72 to 2.60)2.06 (-0.42 to 4.55)1.34 (-1.06 to 3.73)
Calcium, day 7, 0.0 hour-0.34 (-2.75 to 2.07)-1.11 (-3.60 to 1.38)-5.82 (-8.28 to -3.36)-6.19 (-8.65 to -3.73)
Calcium, day 7, 4.0 hours post dose-2.45 (-4.09 to -0.81)-2.17 (-3.87 to -0.47)-8.46 (-10.95 to -5.98)-7.42 (-9.90 to -4.94)
Calcium, day 7, 6.0 hours post dose-4.30 (-5.65 to -2.95)-3.53 (-4.93 to -2.12)-9.12 (-11.54 to -6.70)-9.89 (-12.32 to -7.47)
Calcium, day 7, 12.0 hours post dose-3.41 (-4.94 to -1.88)-1.27 (-2.86 to 0.32)-4.63 (-6.89 to -2.36)-4.99 (-7.25 to -2.73)
Chloride, day 1, 2.0 hours post dose-0.33 (-1.05 to 0.39)-0.47 (-1.22 to 0.28)-0.35 (-0.96 to 0.27)0.22 (-0.38 to 0.81)
Chloride, day 1, 4.0 hours post dose-1.35 (-2.07 to -0.64)-0.61 (-1.36 to 0.14)0.05 (-0.62 to 0.72)0.41 (-0.23 to 1.05)
Chloride, day 1, 6.0 hours post dose-0.66 (-1.35 to 0.03)-0.42 (-1.14 to 0.30)-0.48 (-1.15 to 0.19)0.05 (-0.59 to 0.70)
Chloride, day 1, 12.0 hours post dose0.46 (-0.49 to 1.41)1.44 (0.45 to 2.42)-0.93 (-1.70 to -0.16)-0.15 (-0.92 to 0.62)
Chloride, day 2, 24 hours post dose0.49 (-0.23 to 1.22)0.73 (-0.02 to 1.48)0.11 (-0.82 to 1.04)0.58 (-0.34 to 1.51)
Chloride, day 7, 0.0 hour1.46 (0.40 to 2.53)1.28 (0.19 to 2.37)0.89 (0.17 to 1.62)0.63 (-0.09 to 1.36)
Chloride, day 7, 4.0 hours post dose0.47 (-0.96 to 1.89)0.22 (-1.26 to 1.69)-0.05 (-0.86 to 0.75)0.28 (-0.50 to 1.07)
Chloride, day 7, 6.0 hours post dose0.87 (-0.29 to 2.03)1.32 (0.11 to 2.52)-0.21 (-1.00 to 0.58)-0.86 (-1.68 to -0.04)
Chloride, day 7, 12.0 hours post dose0.98 (-0.12 to 2.09)1.20 (0.06 to 2.35)-1.16 (-2.08 to -0.25)-1.48 (-2.43 to -0.53)
Potassium, day 1, 2.0 hours post dose1.96 (-0.71 to 4.63)-1.25 (-4.01 to 1.51)-1.20 (-3.86 to 1.45)1.69 (-0.86 to 4.24)
Potassium, day 1, 4.0 hours post dose-0.16 (-3.73 to 3.41)-0.11 (-3.80 to 3.58)0.42 (-6.10 to 6.95)1.11 (-5.17 to 7.39)
Potassium, day 1, 6.0 hours post dose-2.91 (-5.82 to 0.01)-5.88 (-8.90 to -2.87)-0.63 (-8.29 to 7.02)-2.61 (-10.00 to 4.79)
Potassium, day 1, 12.0 hours post dose6.63 (-0.02 to 13.28)15.27 (8.40 to 22.15)18.57 (10.49 to 26.64)19.96 (11.85 to 28.08)
Potassium, day 2, 24.0 hours post dose2.06 (-1.44 to 5.56)0.14 (-3.48 to 3.76)7.70 (1.23 to 14.18)7.00 (0.51 to 13.49)
Potassium, day 7, 0.0 hour1.06 (-2.80 to 4.93)-1.55 (-5.55 to 2.45)-0.47 (-4.70 to 3.76)1.29 (-2.93 to 5.52)
Potassium, day 7, 4.0 hours post dose-2.16 (-5.21 to 0.89)-2.93 (-6.08 to 0.22)3.61 (-5.71 to 12.94)0.28 (-8.60 to 9.16)
Potassium, day 7, 6.0 hours post dose-3.23 (-6.47 to 0.00)-5.16 (-8.49 to -1.84)-4.20 (-10.85 to 2.45)-4.14 (-11.06 to 2.78)
Potassium, day 7, 12.0 hours post dose17.22 (9.58 to 24.86)12.32 (4.37 to 20.26)18.19 (7.38 to 29.01)19.28 (8.12 to 30.45)
Sodium, day 1, 2.0 hours post dose-1.09 (-1.68 to -0.50)-0.67 (-1.28 to -0.05)-0.63 (-1.10 to -0.16)-0.17 (-0.63 to 0.29)
Sodium, day 1, 4.0 hours post dose-1.82 (-2.52 to -1.13)-1.18 (-1.90 to -0.45)-0.18 (-0.84 to 0.48)-0.04 (-0.67 to 0.59)
Sodium, day 1, 6.0 hours post dose-1.47 (-2.09 to -0.84)-1.12 (-1.77 to -0.47)-0.62 (-1.20 to -0.04)-0.17 (-0.73 to 0.39)
Sodium, day 1, 12.0 hours post dose-0.17 (-0.74 to 0.39)0.48 (-0.11 to 1.07)-0.12 (-0.91 to 0.68)0.14 (-0.66 to 0.93)
Sodium, day 2, 24.0 hours post dose0.03 (-0.78 to 0.84)1.06 (0.22 to 1.90)0.85 (0.24 to 1.45)1.24 (0.63 to 1.84)
Sodium, day 7, 0.0 hour1.21 (0.23 to 2.18)1.36 (0.35 to 2.37)0.69 (0.05 to 1.33)0.84 (0.20 to 1.48)
Sodium, day 7, 4.0 hours post dose-0.25 (-1.46 to 0.95)-0.89 (-2.14 to 0.37)-0.81 (-1.57 to -0.05)-0.16 (-0.89 to 0.57)
Sodium, day 7, 6.0 hours post dose0.01 (-1.17 to 1.19)-0.19 (-1.42 to 1.05)-0.74 (-1.36 to -0.13)-0.86 (-1.49 to -0.23)
Sodium, day 7, 12.0 hours post dose0.34 (-0.62 to 1.29)0.78 (-0.22 to 1.77)-0.41 (-1.23 to 0.42)-1.04 (-1.89 to -0.20)
SecondaryPercent Change From Baseline in Blood Plasma Creatinine

Blood plasma creatinine was analyzed at a central laboratory.

Time frame:
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
Reported as:
Least squares mean · Percentage change
Percent Change From Baseline in Blood Plasma Creatinine
Percentage changeLCZ696 - Heart Failure (HF) CohortValsartan - HF CohortLCZ696 - Hypertension (HTN) CohortValsartan - HTN Cohort
Day 1, 4.0 hours post dose-7.06 (-9.03 to -5.10)-3.55 (-5.56 to -1.54)-7.48 (-9.28 to -5.68)-0.91 (-2.65 to 0.83)
Day 1, 6.0 hrs post dose-2.97 (-5.49 to -0.46)-0.07 (-2.67 to 2.54)-1.72 (-5.41 to 1.96)4.40 (0.84 to 7.95)
Day 1, 12.0 hrs post dose3.02 (-1.96 to 8.00)5.36 (0.21 to 10.52)6.22 (1.90 to 10.54)9.23 (5.07 to 13.40)
Day 2, 24 hrs post dose3.73 (-1.37 to 8.83)4.02 (-1.26 to 9.30)13.64 (8.44 to 18.84)6.18 (1.15 to 11.21)
Day 7, 0.0 hour4.24 (-6.71 to 15.19)0.55 (-10.43 to 11.52)1.76 (-1.74 to 5.27)1.71 (-1.79 to 5.21)
Day 7, 4.0 hrs post dose-1.47 (-8.56 to 5.63)-5.09 (-12.26 to 2.07)-3.02 (-6.71 to 0.68)-1.28 (-4.98 to 2.41)
Day 7, 6.0 hrs post dose1.72 (-6.15 to 9.59)-0.25 (-8.18 to 7.68)0.48 (-3.44 to 4.40)3.03 (-0.89 to 6.94)
Day 7, 12 hrs post dose8.03 (-3.02 to 19.07)8.34 (-2.79 to 19.48)9.33 (4.43 to 14.24)4.55 (-0.35 to 9.46)
SecondaryGlomerular Filtration Rate (GFR) Over Time

GFR was used as a measure of renal function.

Time frame:
0, 2, 4 and 6 hours post dose on day 1; 0, 2, 4 and 6 hours post dose on day 7
Reported as:
Mean · mL/min
Glomerular Filtration Rate (GFR) Over Time
mL/minLCZ696 - Heart Failure (HF) CohortValsartan - HF CohortLCZ696 - Hypertension (HTN) CohortValsartan - HTN Cohort
Day 1, 0 hour76.4 ± 43.2792.5 ± 97.3787.6 ± 64.2799.2 ± 66.36
Day 1, 2 hours post dose115.7 ± 57.8983.3 ± 46.57112.1 ± 63.3096.0 ± 44.23
Day 1, 4 hours post dose117.4 ± 75.0970.9 ± 36.64125.4 ± 95.33101.8 ± 65.34
Day 1, 6 hours post dose120.2 ± 68.7371.7 ± 37.27148.4 ± 138.66123.0 ± 60.62
Day 7, 0 hour93.7 ± 75.9887.8 ± 57.4796.8 ± 78.6583.2 ± 53.11
Day 7, 2 hours post dose95.9 ± 39.4783.1 ± 35.65133.5 ± 67.8291.4 ± 50.57
Day 7, 4 hours post dose89.6 ± 52.2394.6 ± 53.43151.7 ± 109.91111.3 ± 59.41
Day 7, 6 hours post dose86.9 ± 49.26126.6 ± 79.95111.5 ± 66.30165.2 ± 228.97
SecondaryRenal Blood Flow (RBF) Over Time

RBF was used as a measure of renal function.

Time frame:
0, 2, 4 and 6 hours post dose on day 1; 0, 2, 4 and 6 hours post dose on day 7
Reported as:
Mean · mL/min
Renal Blood Flow (RBF) Over Time
mL/minLCZ696 - Heart Failure (HF) CohortValsartan - HF CohortLCZ696 - Hypertension (HTN) CohortValsartan - HTN Cohort
Day 1, 0 hour398.1 ± 221.24305.7 ± 159.44774.7 ± 893.23737.0 ± 323.14
Day 1, 2 hours post dose361.3 ± 171.80357.4 ± 218.28570.5 ± 212.67541.7 ± 179.20
Day 1, 4 hours post dose340.1 ± 169.87297.4 ± 219.83700.0 ± 408.73573.4 ± 287.14
Day 1, 6 hours post dose465.2 ± 276.84290.05 ± 138.301165.2 ± 912.25758.7 ± 375.11
Day 7, 0 hour354.9 ± 223.49417.0 ± 254.35548.5 ± 389.77549.3 ± 247.41
Day 7, 2 hours331.9 ± 180.59341.1 ± 156.86630.4 ± 239.55659.1 ± 426.18
Day 7, 4 hours324.2 ± 168.10285.9 ± 150.82653.2 ± 412.91606.3 ± 224.57
Day 7, 6 hours331.0 ± 228.38440.8 ± 310.64667.6 ± 308.52977.9 ± 975.25
SecondarySupine Systolic Blood Pressure

Systolic blood pressure measurements were taken.

Time frame:
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
Reported as:
Mean · mmHg
Supine Systolic Blood Pressure
mmHgLCZ696 - Heart Failure (HF) CohortValsartan - HF CohortLCZ696 - Hypertension (HTN) CohortValsartan - HTN Cohort
Day 1, 0.0 hour114.8 ± 14.10127.0 ± 16.62136.1 ± 18.80133.2 ± 14.79
Day 1, 0.5 hour post dose122.8 ± 14.36121.5 ± 21.78132.9 ± 19.52132.5 ± 17.85
Day 1, 1.0 hour post dose123.9 ± 16.53122.2 ± 19.20134.1 ± 18.57133.2 ± 15.22
Day 1, 2.0 hours post dose125.4 ± 13.68127.2 ± 16.71134.2 ± 19.85132.6 ± 17.47
Day 1, 4.0 hours post dose133.1 ± 18.65130.3 ± 17.14140.7 ± 20.67142.1 ± 17.93
Day 1, 8.0 hours post dose113.6 ± 13.29120.9 ± 16.85127.3 ± 17.39132.2 ± 11.40
Day 1, 12.0 hours post dose111.1 ± 14.75114.8 ± 17.85127.4 ± 13.92134.1 ± 14.64
Day 2115.8 ± 9.61120.9 ± 18.05125.4 ± 12.66128.9 ± 13.99
Day 7, 0.0 hour110.5 ± 10.03115.9 ± 15.47128.9 ± 14.83128.8 ± 13.76
Day 7, 0.5 hour post dose116.2 ± 10.93122.9 ± 11.78127.4 ± 16.26130.9 ± 15.06
Day 7, 1.0 hour post dose117.9 ± 10.01124.8 ± 12.43127.4 ± 17.46130.9 ± 15.47
Day 7, 2.0 hours post dose119.3 ± 12.70127.5 ± 11.95128.6 ± 19.35140.7 ± 15.89
Day 7, 4.0 hours post dose120.6 ± 11.71128.9 ± 13.13130.5 ± 18.15134.9 ± 13.20
Day 7, 8.0 hours post dose111.3 ± 12.52119.3 ± 10.44123.1 ± 12.72130.0 ± 15.88
Day 7, 12.0 hours post dose107.9 ± 16.70116.5 ± 14.85120.3 ± 12.60131.9 ± 18.71
SecondarySupine Diastolic Blood Pressure

Diastolic blood pressure measurements were taken.

Time frame:
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
Reported as:
Mean · mmHg
Supine Diastolic Blood Pressure
mmHgLCZ696 - Heart Failure (HF) CohortValsartan - HF CohortLCZ696 - Hypertension (HTN) CohortValsartan - HTN Cohort
Day 1, 0.0 hour68.2 ± 9.8574.1 ± 13.2077.6 ± 10.5774.9 ± 9.99
Day 1, 0.5 hour post dose71.2 ± 12.0075.5 ± 13.7776.3 ± 11.8575.8 ± 10.67
Day 1, 1.0 hour post dose71.3 ± 12.0075.8 ± 13.7375.3 ± 10.3776.2 ± 9.59
Day 1, 2.0 hours post dose73.3 ± 12.0177.1 ± 10.6177.6 ± 11.7976.0 ± 10.78
Day 1, 4.0 hours post dose75.6 ± 13.7779.1 ± 12.2180.0 ± 13.6079.9 ± 9.08
Day 1, 8.0 hours post dose68.5 ± 11.1570.4 ± 11.1275.2 ± 10.2376.2 ± 8.89
Day 1, 12.0 hours post dose65.4 ± 11.4971.7 ± 13.4375.5 ± 8.3375.7 ± 8.81
Day 271.6 ± 10.0374.9 ± 13.3373.2 ± 10.7875.1 ± 8.35
Day 7, 0.0 hour66.9 ± 11.0468.4 ± 11.3774.7 ± 8.7774.7 ± 9.62
Day 7, 0.5 hour post dose69.6 ± 11.7473.9 ± 9.4874.3 ± 9.3674.5 ± 9.65
Day 7, 1.0 hour post dose69.3 ± 10.4973.9 ± 8.9473.5 ± 8.5275.1 ± 8.71
Day 7, 2.0 hours post dose70.6 ± 11.8576.7 ± 9.1572.0 ± 8.2078.8 ± 9.29
Day 7, 4.0 hours post dose69.6 ± 11.1774.5 ± 10.8674.4 ± 9.6078.4 ± 9.77
Day 7, 8.0 hours post dose69.3 ± 10.0871.5 ± 8.4371.4 ± 7.8475.3 ± 8.50
Day 7, 12.0 hours post dose65.3 ± 10.9569.8 ± 12.3970.7 ± 8.3675.7 ± 11.47
SecondarySupine Pulse Rate

Pulse rate measurements were taken.

Time frame:
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
Reported as:
Mean · BPM
Supine Pulse Rate
BPMLCZ696 - Heart Failure (HF) CohortValsartan - HF CohortLCZ696 - Hypertension (HTN) CohortValsartan - HTN Cohort
Day 1, 0.0 hour56.8 ± 8.8961.7 ± 14.3065.7 ± 9.2665.5 ± 8.44
Day 1, 0.5 hour post dose61.3 ± 9.3460.7 ± 10.4564.1 ± 8.5963.4 ± 9.29
Day 1, 1.0 hour post dose62.4 ± 8.9762.7 ± 10.1964.2 ± 7.4964.0 ± 10.39
Day 1, 2.0 hours post dose61.0 ± 9.0264.3 ± 12.3965.6 ± 8.2863.2 ± 8.89
Day 1, 4.0 hours post dose60.0 ± 8.5162.9 ± 13.2964.0 ± 6.5165.3 ± 9.65
Day 1, 8.0 hours post dose67.6 ± 11.7069.1 ± 11.3473.9 ± 10.2067.5 ± 10.09
Day 1, 12.0 hours post dose61.1 ± 13.3662.8 ± 10.8373.7 ± 13.5265.4 ± 9.68
Day 260.1 ± 12.1864.5 ± 11.9571.3 ± 10.5866.5 ± 9.20
Day 7, 0.0 hour post dose63.0 ± 11.9760.6 ± 12.6962.9 ± 5.5462.8 ± 8.16
Day 7, 0.5 hour post dose65.0 ± 12.6360.1 ± 12.0763.0 ± 4.3661.8 ± 9.35
Day 7, 1.0 hour post dose63.3 ± 13.2161.6 ± 11.7062.3 ± 5.8761.6 ± 7.70
Day 7, 2.0 hours post dose63.9 ± 10.4258.7 ± 11.4961.2 ± 6.1763.6 ± 9.16
Day 7, 4.0 hours post dose65.7 ± 10.8560.7 ± 11.3462.9 ± 6.4562.7 ± 9.20
Day 7, 8.0 hours post dose67.1 ± 10.2066.5 ± 11.8066.3 ± 7.3464.8 ± 10.83
Day 7, 12.0 hours post dose66.7 ± 13.2871.9 ± 17.3066.2 ± 6.9767.1 ± 11.10

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
LCZ696 - Heart Failure (HF) Cohort—0/16 (0%)3/16 (18.8%)
Valsartan - HF Cohort—0/15 (0%)1/15 (6.7%)
LCZ696 - Hypertension (HTN) Cohort—0/15 (0%)1/15 (6.7%)
Valsartan - HTN Cohort—0/16 (0%)3/16 (18.8%)
Most frequent other events
Most frequent other events
EventLCZ696 - Heart Failure (HF) CohortValsartan - HF CohortLCZ696 - Hypertension (HTN) CohortValsartan - HTN Cohort
ToothacheGastrointestinal disorders0/160/151/150/16
Blood creatinine increasedInvestigations1/161/150/150/16
Abdominal pain upperGastrointestinal disorders0/160/150/151/16
NasopharyngitisInfections and infestations1/160/150/150/16
DizzinessNervous system disorders1/160/150/150/16
HeadacheNervous system disorders0/160/150/151/16
PresyncopeNervous system disorders1/160/150/150/16
DysuriaRenal and urinary disorders0/160/150/151/16

Baseline characteristics

Age, Continuous
Age, Continuous(Years)LCZ696 to Valsartan - Heart Failure (HF) CohortValsartan to LCZ696 - HF CohortLCZ696 to Valsartan - Hypertension (HTN) CohortValsartan to LCZ696 - HTN CohortTotal
Mean63.3 ± 10.1567.6 ± 9.0758.0 ± 8.0261.6 ± 8.4062.6 ± 8.86
Sex: Female, Male
Sex: Female, Male(Participants)LCZ696 to Valsartan - Heart Failure (HF) CohortValsartan to LCZ696 - HF CohortLCZ696 to Valsartan - Hypertension (HTN) CohortValsartan to LCZ696 - HTN CohortTotal
Female20529
Male683623
08

Study locations

1 site
  • Novartis Investigative Site
    Moscow, 117198, Russian Federation
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01353508
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
May 13, 2011
Start date
Mar 2011
Primary completion
Aug 2012
Completion
Aug 2012
Results posted
Nov 23, 2015
Last update
Nov 23, 2015

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hypertension→

Other studies from this sponsor

Novartis Pharmaceuticals

Start the discussion