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CompletedNCT01615198Updated Oct 23, 2015Results posted

Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension

A Phase 3 interventional study of Olmesartan and Placebo in Essential Hypertension, sponsored by Novartis Pharmaceuticals. Completed at 78 sites in 7 countries. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2015-10-23.

Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
588
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

The purpose of this study is to access the efficacy and safety of LCZ696 compared to olmesartan in elderly Asian patients for the treatment of hypertension.

02

Conditions studied

  • Essential Hypertension

Keywords

  • Hypertension, blood pressure, LCZ696, dual inhibitor, neprilysin, NEP inhibition, vasopeptidase, ARNi, angiotensin receptor
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 588 is above 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
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients must give written informed consent before any assessment is performed
  • Patients with essential hypertension, untreated or currently taking antihypertensive therapy must have a mean sitting systolic blood pressure ≥ 150 mmHg and \< 180 mmHg
  • Patients must be able to communicate and comply with all study requirements and demonstrate good medication compliance

Exclusion criteria

Exclusion criteria:

  • Patients with severe hypertension (msDBP ≥ 110 mmHg and/or msSBP ≥180 mmHg). Patients with history of angioedema, drug-related or otherwise
  • Patients with history or evidence of a secondary form of hypertension
  • Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke
  • History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1.
  • Current angina pectoris requiring medication (other than patients on a stable dose of oral or topical nitrates).
  • Patients with Type 1 or Type 2 diabetes mellitus who are not well controlled and are not on a stable dose of antidiabetic medication
  • Patients with previous or current diagnosis of heart failure (NYHA Class II-IV).
  • Patients with a clinically significant valvular heart disease at the time of screening
  • Women of child-bearing potential, who do not use adequate birth control methods Other protocol-defined inclusion/exclusion criteria may apply
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
588 participants (actual)

Study arms

  • Experimental
    LCZ696

    Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.

    Drug: Placebo · Drug: LCZ696

  • Active comparator
    Olmesartan

    Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.

    Drug: Olmesartan · Drug: Placebo

Interventions

  • DrugOlmesartan

    10 mg, 20 mg, 40 mg capsules

  • DrugPlacebo

    Matching placebo of LCZ696 tablet, matching placebo of Olmesartan capsule

  • DrugLCZ696

    100 mg, 200 mg tablets

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

    Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.

    Time frame: Baseline, 10 weeks

Secondary outcomes

  1. Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)

    ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.

    Time frame: Baseline, 10 weeks

  2. Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)

    Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicated improvement.

    Time frame: Baseline, 4 weeks, 14 weeks

  3. Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)

    ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.

    Time frame: Baseline, 10 weeks

  4. Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)

    Sitting BP measurements was performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.

    Time frame: Baseline, 10 weeks

  5. Change From Baseline in Mean Sitting Pulse Pressure

    Pulse rate was with automated BP device after the 4th blood pressure measurement at each visit.

    Time frame: Baseline, 4 weeks, 10 weeks, 14 weeks

  6. Change From Baseline in Daytime and Nighttime maSBP/maDBP

    ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.

    Time frame: Baseline, 10 weeks

  7. Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers

    ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A non-dipper was defined as a participant who, at baseline, had a mean nighttime ABPM (10 pm - 6 am) that did not drop ≥ 10% below his or her mean daytime ABPM (6 am - 10 pm). A negative change from baseline indicates improvement.

    Time frame: Baseline, 10 weeks

  8. Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers

    ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A non-dipper was defined as a participant who, at baseline, had a mean nighttime ABPM (10 pm - 6 am) that did not drop ≥ 10% below his or her mean daytime ABPM (6 am - 10 pm). A negative change from baseline indicates improvement.

    Time frame: Baseline, 10 weeks

  9. Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)

    A successful response in overall BP control rate was defined as msSBP \< 140 mmHg and msDBP \<90 mmHg.

    Time frame: 4 weeks, 10 weeks, 14 weeks

  10. Number of Participants Achieving Successful Response in msSBP and msDBP

    Blood pressure response in msSBP was defined as a mean sitting BP \< 140 mmHg or a \>=20 mmHg reduction from baseline. Blood pressure response in msDBP was defined as a mean sitting diastolic blood pressure, 90 mmHg or \>=10 mmHg reduction from baseline.

    Time frame: 4 weeks,10 weeks, 14 weeks

  11. Number of Participants With Adverse Events, Serious Adverse Events and Death

    Adverse event monitoring was conducted throughout the study.

    Time frame: 14 weeks

07

Results

Posted Aug 18, 2015

Participant flow

Participant flow — Overall Study
MilestoneLCZ696Olmesartan
Started296292
Full analysis set296292
Ambulatory bp monitoring (abpm) subset154157
Safety set296292
Abpm dipper status subset8284
Completed272273
Not completed2419
Withdrew: Withdrawal by subject55
Withdrew: Protocol deviation11
Withdrew: Physician decision51
Withdrew: Lost to follow-up11
Withdrew: Lack of efficacy16
Withdrew: Adverse event115

Outcome measures

PrimaryChange From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.

Time frame:
Baseline, 10 weeks
Reported as:
Least squares mean · mmHg
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
mmHgLCZ696Olmesartan
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)-22.71 ± 0.91-16.11 ± 0.92
SecondaryChange From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)

ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.

Time frame:
Baseline, 10 weeks
Reported as:
Least squares mean · mmHg
Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)
mmHgLCZ696Olmesartan
Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)-14.23 ± 0.56-9.14 ± 0.56
SecondaryChange From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)

Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicated improvement.

Time frame:
Baseline, 4 weeks, 14 weeks
Reported as:
Least squares mean · mmHg
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
mmHgLCZ696Olmesartan
msSBP, week 4-17.64 ± 0.83-15.81 ± 0.84
msDBP, week 4-6.08 ± 0.44-5.58 ± 0.45
msSBP, week 14-22.53 ± 0.92-16.75 ± 0.94
msDBP, week 14-7.92 ± 0.49-5.97 ± 0.49
SecondaryChange in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)

ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.

Time frame:
Baseline, 10 weeks
Reported as:
Least squares mean · mmHg
Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)
mmHgLCZ696Olmesartan
Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)-6.95 ± 0.31-4.47 ± 0.31
SecondaryChange From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)

Sitting BP measurements was performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.

Time frame:
Baseline, 10 weeks
Reported as:
Least squares mean · mmHg
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
mmHgLCZ696Olmesartan
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)-8.58 ± 0.47-6.49 ± 0.48
SecondaryChange From Baseline in Mean Sitting Pulse Pressure

Pulse rate was with automated BP device after the 4th blood pressure measurement at each visit.

Time frame:
Baseline, 4 weeks, 10 weeks, 14 weeks
Reported as:
Least squares mean · mmHg
Change From Baseline in Mean Sitting Pulse Pressure
mmHgLCZ696Olmesartan
week 4-11.57 ± 0.60-10.38 ± 0.61
week 10-14.21 ± 0.63-9.76 ± 0.64
week 14-14.65 ± 0.64-10.90 ± 0.65
SecondaryChange From Baseline in Daytime and Nighttime maSBP/maDBP

ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.

Time frame:
Baseline, 10 weeks
Reported as:
Least squares mean · mmHg
Change From Baseline in Daytime and Nighttime maSBP/maDBP
mmHgLCZ696Olmesartan
maSBP, daytime-14.32 ± 0.96-10.02 ± 0.96
maSBP, nighttime-13.97 ± 0.96-7.68 ± 0.96
maDBP, daytime-7.04 ± 0.55-4.88 ± 0.56
maDBP, nighttime-6.70 ± 0.55-3.61 ± 0.56
SecondaryChange From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers

ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A non-dipper was defined as a participant who, at baseline, had a mean nighttime ABPM (10 pm - 6 am) that did not drop ≥ 10% below his or her mean daytime ABPM (6 am - 10 pm). A negative change from baseline indicates improvement.

Time frame:
Baseline, 10 weeks
Reported as:
Mean · mmHg
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers
mmHgLCZ696Olmesartan
maSBP, hour 1 (n=58,66)-18.48 ± 14.550-14.15 ± 15.677
maSBP, hour 2 (n=62,66)-20.75 ± 15.713-17.26 ± 16.843
maSBP, hour 3 (n=62,68)-17.44 ± 18.884-12.65 ± 18.923
maSBP, hour 4 (n=62,68)-16.90 ± 16.539-14.83 ± 17.823
maSBP, hour 5 (n=61,67)-16.70 ± 17.689-16.16 ± 19.460
maSBP, hour 6 (n=62,68)-18.11 ± 17.856-15.00 ± 19.025
maSBP, hour 7 (n=62,68)-17.60 ± 18.330-14.74 ± 20.142
maSBP, hour 8 (n=62,67)-15.81 ± 15.872-16.37 ± 17.552
maSBP, hour 9 (n=62,68)-14.06 ± 12.877-13.55 ± 19.456
maSBP, hour 10 (n=62,68)-15.55 ± 15.232-13.50 ± 17.522
maSBP, hour 11 (n=62,68)-13.17 ± 17.903-13.32 ± 18.198
maSBP, hour 12 (n=62,68)-12.36 ± 17.222-13.43 ± 20.898
maSBP, hour 13 (n=62,68)-8.71 ± 19.359-10.84 ± 19.697
maSBP, hour 14 (n=62,68)-7.10 ± 20.651-9.96 ± 19.663
maSBP, hour 15 (n=62,67)-9.05 ± 18.528-8.68 ± 17.094
maSBP, hour 16 (n=62,68)-9.90 ± 17.994-7.81 ± 16.344
maSBP, hour 17 (n=62,68)-9.88 ± 16.098-5.49 ± 15.031
maSBP, hour 18 (n=61,68)-11.19 ± 16.482-4.88 ± 13.065
maSBP, hour 19 (n=62,68)-12.38 ± 15.010-6.69 ± 15.146
maSBP, hour 20 (n=62,68)-15.18 ± 16.683-9.40 ± 18.217
maSBP, hour 21 (n=62,67)-13.71 ± 19.977-9.04 ± 15.748
maSBP, hour 22 (n=62,68)-19.28 ± 19.387-9.61 ± 18.940
maSBP, hour 23 (n=60,66)-16.88 ± 15.442-10.54 ± 19.470
maSBP, hour 24 (n=57,67)-17.28 ± 13.472-16.03 ± 19.076
maDBP, hour 1 (n=58,66)-8.34 ± 9.640-7.30 ± 8.732
maDBP, hour 2 (n=62,66)-9.13 ± 9.854-7.80 ± 10.747
maDBP, hour 3 (n=62,68)-8.41 ± 11.698-8.21 ± 9.857
maDBP, hour 4 (n=62,68)-7.35 ± 10.656-8.98 ± 9.835
maDBP, hour 5 (n=61,67)-8.17 ± 10.919-8.35 ± 10.282
maDBP, hour 6 (n=62,68)-8.39 ± 10.623-8.09 ± 12.360
maDBP, hour 7 (n=62,68)-9.14 ± 11.350-7.35 ± 12.345
maDBP, hour 8 (n=62,67)-7.50 ± 9.680-8.50 ± 10.839
maDBP, hour 9 (n=62,68)-7.01 ± 9.374-6.65 ± 12.287
maDBP, hour 10 (n=62,68)-7.83 ± 9.907-6.70 ± 11.536
maDBP, hour 11 (n=62,68)-8.08 ± 10.588-6.65 ± 11.023
maDBP, hour 12 (n=62,68)-7.38 ± 11.993-7.64 ± 13.479
maDBP, hour 13 (n=-62,68)-4.36 ± 11.325-7.16 ± 12.916
maDBP, hour 14 (n=62,68)-2.70 ± 13.661-6.28 ± 10.794
maDBP, hour 15 (n=62,67)-4.02 ± 12.943-3.05 ± 11.417
maDBP, hour 16 (n=62,68)-4.84 ± 13.097-3.88 ± 10.015
maDBP, hour 17 (n=62,68)-5.71 ± 12.089-3.74 ± 11.261
maDBP, hour 18 (n=61,68)-5.36 ± 11.213-1.65 ± 8.939
maDBP, hour 19 (n=62,68)-6.10 ± 11.197-3.42 ± 9.726
maDBP, hour 20 (n=62,68)-6.75 ± 10.878-4.00 ± 12.452
maDBP, hour 21 (n=62,67)-6.91 ± 12.251-4.40 ± 9.746
maDBP, hour 22 (n=62,68)-10.22 ± 11.394-4.48 ± 11.019
maDBP, hour 23 (n=60,66)-7.85 ± 9.030-5.11 ± 9.826
maDBP, hour 24 (n=57,67)-7.83 ± 10.057-6.62 ± 10.418
SecondaryChange From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers

ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A non-dipper was defined as a participant who, at baseline, had a mean nighttime ABPM (10 pm - 6 am) that did not drop ≥ 10% below his or her mean daytime ABPM (6 am - 10 pm). A negative change from baseline indicates improvement.

Time frame:
Baseline, 10 weeks
Reported as:
Mean · mmHg
Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers
mmHgLCZ696Olmesartan
maSBP, hour 1 (n=84,84)-13.42 ± 16.050-9.53 ± 18.224
maSBP, hour 2 (n=89,85)-15.60 ± 18.144-8.57 ± 17.848
maSBP, hour 3 (n=90,88)-13.17 ± 15.690-6.33 ± 17.694
maSBP, hour 4 (n=91,88)-13.93 ± 17.260-4.98 ± 16.155
maSBP, hour 5 (n=90,88)-12.90 ± 19.372-4.68 ± 16.264
maSBP, hour 6 (n=90,89)-12.96 ± 22.547-5.49 ± 18.843
maSBP, hour 7 (n=91,89)-12.68 ± 21.126-6.64 ± 17.191
maSBP, hour 8 (n=91,88)-12.65 ± 18.450-7.45 ± 17.912
maSBP, hour 9 (n=91,89)-13.51 ± 17.381-7.81 ± 16.968
maSBP, hour 10 (n=92,89)-12.96 ± 17.350-7.63 ± 18.620
maSBP, hour 11 (n=92,89)-12.69 ± 18.724-6.89 ± 16.115
maSBP, hour 12 (n=92,88)-13.82 ± 17.493-3.92 ± 17.244
maSBP, hour 13 (n=92,89)-16.51 ± 16.485-5.49 ± 18.209
maSBP, hour 14 (n=92,88)-19.39 ± 16.860-5.16 ± 16.856
maSBP, hour 15 (n=92,89)-19.33 ± 19.863-5.92 ± 17.627
maSBP, hour 16 (n=92,89)-17.95 ± 18.731-6.57 ± 18.512
maSBP, hour 17 (n=92,89)-17.34 ± 17.015-12.03 ± 18.990
maSBP, hour 18 (n=92,88)-16.45 ± 16.439-8.54 ± 17.397
maSBP, hour 19 (n=91,89)-15.81 ± 16.349-9.33 ± 17.027
maSBP, hour 20 (n=92,89)-15.33 ± 15.556-6.77 ± 16.228
maSBP, hour 21 (n=91,89)-14.78 ± 15.790-7.10 ± 17.961
maSBP, hour 22 (n=91,89)-13.99 ± 15.653-6.05 ± 15.806
maSBP, hour 23 (n=92,85)-10.93 ± 14.121-8.48 ± 16.760
maSBP, hour 24 (n=86,85)-14.19 ± 15.072-7.98 ± 16.160
msDBP, hour 1 (n=84,84)-7.01 ± 9.033-4.59 ± 10.061
msDBP, hour 2 (n=89,85)-7.39 ± 10.516-3.32 ± 11.104
msDBP, hour 3 (n=90,88)-6.61 ± 10.473-3.77 ± 12.284
msDBP, hour 4 (n=91,88)-7.08 ± 9.826-2.24 ± 11.169
msDBP, hour 5 (n=90,88)-5.75 ± 13.156-1.53 ± 12.069
msDBP, hour 6 (n=90,89)-7.06 ± 13.704-2.00 ± 11.418
msDBP, hour 7 (n=91,89)-5.69 ± 12.453-1.70 ± 11.797
msDBP, hour 8 (n=91,88)-6.13 ± 10.420-3.04 ± 11.240
msDBP, hour 9 (n=91,89)-7.05 ± 10.348-3.62 ± 10.743
msDBP, hour 10 (n=92,89)-5.28 ± 10.221-3.14 ± 10.849
msDBP, hour 11 (n=92,89)-6.18 ± 11.825-3.18 ± 10.216
msDBP, hour 12 (n=92,88)-6.36 ± 11.313-1.61 ± 10.970
msDBP, hour 13 (n=92,89)-8.63 ± 11.364-2.41 ± 10.750
msDBP, hour 14 (n=92,88)-9.68 ± 11.518-1.69 ± 11.103
msDBP, hour 15 (n=92,89)-9.60 ± 13.266-2.85 ± 11.012
msDBP, hour 16 (n=92,89)-8.48 ± 11.992-2.54 ± 11.523
msDBP, hour 17 (n=92,89)-7.60 ± 9.661-5.44 ± 11.105
msDBP, hour 18 (n=92,88)-8.60 ± 11.526-4.25 ± 11.062
msDBP, hour 19 (n=91,89)-7.46 ± 10.284-3.93 ± 11.088
msDBP, hour 20 (n=92,89)-6.21 ± 10.295-3.10 ± 9.792
msDBP, hour 21 (n=91,89)-7.63 ± 10.871-2.81 ± 11.002
msDBP, hour 22 (n=91,89)-6.97 ± 10.589-2.60 ± 10.568
msDBP, hour 23 (n=92,85)-5.72 ± 9.410-2.12 ± 11.612
msDBP, hour 24 (n=86,85)-6.57 ± 9.916-3.91 ± 9.240
SecondaryNumber of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)

A successful response in overall BP control rate was defined as msSBP \< 140 mmHg and msDBP \<90 mmHg.

Time frame:
4 weeks, 10 weeks, 14 weeks
Reported as:
Number · Participants
Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
ParticipantsLCZ696Olmesartan
4 weeks140120
10 weeks175130
14 weeks173126
SecondaryNumber of Participants Achieving Successful Response in msSBP and msDBP

Blood pressure response in msSBP was defined as a mean sitting BP \< 140 mmHg or a \>=20 mmHg reduction from baseline. Blood pressure response in msDBP was defined as a mean sitting diastolic blood pressure, 90 mmHg or \>=10 mmHg reduction from baseline.

Time frame:
4 weeks,10 weeks, 14 weeks
Reported as:
Number · Participants
Number of Participants Achieving Successful Response in msSBP and msDBP
ParticipantsLCZ696Olmesartan
msSBP, week 4162146
msSBP, week 10208142
msSBP, week 14205144
msDBP, week 4264245
msDBP, week 10275254
msDBP, week 14268246
SecondaryNumber of Participants With Adverse Events, Serious Adverse Events and Death

Adverse event monitoring was conducted throughout the study.

Time frame:
14 weeks
Reported as:
Number · Participants
Number of Participants With Adverse Events, Serious Adverse Events and Death
ParticipantsLCZ696Olmesartan
Adverse events (non-serious and serious)141113
Serious adverse events72
Deaths00

Adverse events

Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
LCZ696—7/296 (2.4%)49/296 (16.6%)
Olmesartan—2/292 (0.7%)44/292 (15.1%)
Most frequent serious events
Most frequent serious events
EventLCZ696Olmesartan
LIVER FUNCTION TEST ABNORMALInvestigations0/2961/292
HENOCH-SCHONLEIN PURPURA NEPHRITISRenal and urinary disorders0/2961/292
ARRHYTHMIACardiac disorders1/2960/292
ATRIAL FIBRILLATIONCardiac disorders1/2960/292
VERTIGOEar and labyrinth disorders1/2960/292
ALANINE AMINOTRANSFERASE INCREASEDInvestigations1/2960/292
ASPARTATE AMINOTRANSFERASE INCREASEDInvestigations1/2960/292
MUSCLE ATROPHYMusculoskeletal and connective tissue disorders1/2960/292
CERVIX CARCINOMANeoplasms benign, malignant and unspecified (incl cysts and polyps)1/2960/292
CEREBRAL INFARCTIONNervous system disorders1/2960/292
Most frequent other events
Most frequent other events
EventLCZ696Olmesartan
NASOPHARYNGITISInfections and infestations24/29618/292
HYPERURICAEMIAMetabolism and nutrition disorders11/29619/292
UPPER RESPIRATORY TRACT INFECTIONInfections and infestations10/2966/292
DIZZINESSNervous system disorders6/2962/292

Baseline characteristics

Age, Continuous
Age, Continuous(Years)LCZ696OlmesartanTotal
Mean70.5 ± 4.6770.9 ± 4.6770.7 ± 4.67
Sex: Female, Male
Sex: Female, Male(Participants)LCZ696OlmesartanTotal
Female154140294
Male142152294
08

Study locations

78 sites
  • Novartis Investigative Site
    Chongqing, Chongqing 400042, China
  • Novartis Investigative Site
    Changsha, Hunan 410003, China
  • Novartis Investigative Site
    Suzhou, Jiangsu 215006, China
  • Novartis Investigative Site
    Shenyang, Liaoning 110003, China
  • Novartis Investigative Site
    Xi'an, Shanxi 710061, China
  • Novartis Investigative Site
    Hangzhou, Zhejiang 310006, China
  • Novartis Investigative Site
    Hangzhou, Zhejiang 310013, China
  • Novartis Investigative Site
    Beijing, 100020, China
  • Novartis Investigative Site
    Shanghai, 200025, China
  • Novartis Investigative Site
    Tianjin, 300142, China
  • Novartis Investigative Site
    Hong Kong, Shatin, NT, Hong Kong
  • Novartis Investigative Site
    Hong Kong, Hong Kong
  • Novartis Investigative Site
    Toon-city, Ehime 791-0295, Japan
  • Novartis Investigative Site
    Chikushi-gun, Fukuoka 811-1244, Japan
  • Novartis Investigative Site
    Fukuoka-city, Fukuoka 810-0066, Japan
  • Novartis Investigative Site
    Kitakyushu-city, Fukuoka 807-0856, Japan
  • Novartis Investigative Site
    Asahikawa, Hokkaido 078-8214, Japan
  • Novartis Investigative Site
    Sapporo-city, Hokkaido 062-0053, Japan
  • Novartis Investigative Site
    Sapporo-city, Hokkaido 063-0842, Japan
  • Novartis Investigative Site
    Sapporo, Hokkaido 003-0026, Japan
  • Novartis Investigative Site
    Sapporo, Hokkaido 003-0825, Japan
  • Novartis Investigative Site
    Kawasaki-city, Kanagawa 210-0852, Japan
  • Novartis Investigative Site
    Kyotanabe-city, Kyoto 610-0361, Japan
  • Novartis Investigative Site
    Kyoto-city, Kyoto 615-8125, Japan
  • Novartis Investigative Site
    Suita-city, Osaka 565-0871, Japan
  • Novartis Investigative Site
    Toyonaka-city, Osaka 560-0082, Japan
  • Novartis Investigative Site
    Fujimino, Saitama 356-0053, Japan
  • Novartis Investigative Site
    Hiki-Gun, Saitama 355-0328, Japan
  • Novartis Investigative Site
    Koshigaya city, Saitama 343-0826, Japan
  • Novartis Investigative Site
    Tokorozawa-city, Saitama 359-1161, Japan
  • Novartis Investigative Site
    Edogawa-ku, Tokyo 133-0061, Japan
  • Novartis Investigative Site
    Edogawa-ku, Tokyo 134-0084, Japan
  • Novartis Investigative Site
    Hachioji-city, Tokyo 192-0918, Japan
  • Novartis Investigative Site
    Hachioji, Tokyo 192-0046, Japan
  • Novartis Investigative Site
    Katsushika-ku, Tokyo 124-0024, Japan
  • Novartis Investigative Site
    Kiyose-city, Tokyo 204-0021, Japan
  • Novartis Investigative Site
    Kunitachi, Tokyo 186-0001, Japan
  • Novartis Investigative Site
    Meguro-ku, Tokyo 152-0031, Japan
  • Novartis Investigative Site
    Minato-ku, Tokyo 105-7390, Japan
  • Novartis Investigative Site
    Minato-ku, Tokyo 108-0075, Japan
  • Novartis Investigative Site
    Shibuya-ku, Tokyo 150-0002, Japan
  • Novartis Investigative Site
    Shinagawa-ku, Tokyo 141-0032, Japan
  • Novartis Investigative Site
    Tachikawa, Tokyo 190-0013, Japan
  • Novartis Investigative Site
    Taito, Tokyo 111-0052, Japan
  • Novartis Investigative Site
    Toshima-ku, Tokyo 171-0021, Japan
  • Novartis Investigative Site
    Osaka, 560-0005, Japan
  • Novartis Investigative Site
    Saitama, 337-0012, Japan
  • Novartis Investigative Site
    Bucheon, Gyeonggi-do 424-717, Korea, Republic of
  • Novartis Investigative Site
    Goyang, Gyeonggi-do 412-270, Korea, Republic of
  • Novartis Investigative Site
    Seongnam, Gyeonggi 463-707, Korea, Republic of
  • Novartis Investigative Site
    Jeonju-si, Jeollabuk-do 561-712, Korea, Republic of
  • Novartis Investigative Site
    Koyang, Kyunggi 410-719, Korea, Republic of
  • Novartis Investigative Site
    Daegu, 700-712, Korea, Republic of
  • Novartis Investigative Site
    Daejeon, 302-241, Korea, Republic of
  • Novartis Investigative Site
    Incheon, 22332, Korea, Republic of
  • Novartis Investigative Site
    Incheon, 403-720, Korea, Republic of
  • Novartis Investigative Site
    Seoul, 100-380, Korea, Republic of
  • Novartis Investigative Site
    Seoul, 134-727, Korea, Republic of
  • Novartis Investigative Site
    Seoul, 135-720, Korea, Republic of
  • Novartis Investigative Site
    Seoul, 150-713, Korea, Republic of
  • Novartis Investigative Site
    Seoul, 150-950, Korea, Republic of
  • Novartis Investigative Site
    Seoul, 152-703, Korea, Republic of
  • Novartis Investigative Site
    Quezon City, Manila 1100, Philippines
  • Novartis Investigative Site
    Manila, Metro Manila 1000, Philippines
  • Novartis Investigative Site
    Quezon City, 1100, Philippines
  • Novartis Investigative Site
    Quezon City, 1102, Philippines
  • Novartis Investigative Site
    Valenzuela City, 1441, Philippines
  • Novartis Investigative Site
    Taichung, Taiwan ROC 40201, Taiwan
  • Novartis Investigative Site
    Taipei, Taiwan, ROC 112, Taiwan
  • Novartis Investigative Site
    Changhua, 500, Taiwan
  • Novartis Investigative Site
    Kaohsiung, 807, Taiwan
  • Novartis Investigative Site
    Taichung, 40447, Taiwan
  • Novartis Investigative Site
    Taipei, 10002, Taiwan
  • Novartis Investigative Site
    Taipei, 114, Taiwan
  • Novartis Investigative Site
    Taipei, Taiwan
  • Novartis Investigative Site
    Bangkok, 10400, Thailand
  • Novartis Investigative Site
    Bangkok, 10700, Thailand
  • Novartis Investigative Site
    Chiang Mai, 50200, Thailand
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 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
NCT01615198
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Jun 8, 2012
Start date
Aug 2012
Primary completion
Jul 2013
Completion
Jul 2013
Results posted
Aug 18, 2015
Last update
Oct 23, 2015

Study contacts

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

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