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CompletedNCT01681576Updated Nov 10, 2015Results posted

Assessment of LCZ696 and Valsartan in Asian Patients With Salt-sensitive Hypertension

A Phase 2 interventional study of Valsartan and LCZ696 in Salt-sensitive Hypertension, sponsored by Novartis Pharmaceuticals. Completed at 15 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-10.

Sponsored by Novartis Pharmaceuticals · Phase 2 and Interventional

Phase
Phase 2
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study will evaluate the effect of LCZ696 and valsartan on natriuresis, diuresis, and blood pressure in salt-sensitive Asian hypertensive patients.

02

Conditions studied

  • Salt-sensitive Hypertension

Keywords

  • hypertension, salt sensitivity, valsartan, LCZ696
03

In context

Hypertension

6,687 studies on the registry are indexed under Hypertension; 964 are open to participants now.

This study's enrollment of 72 is below the median of 90 across 4,994 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

Eligibility criteria

Key Inclusion Criteria:

  • Written informed consent must be obtained before any study assessment is performed.
  • Males and females of non-childbearing potential and of legal age (at least 18 years or older as defined by local law).
  • Asian patients with mild to moderate essential hypertension, untreated or currently taking antihypertensive therapy with up to two drugs.

Key Exclusion Criteria:

  • Women of child-bearing potential.
  • History of angioedema, drug-related or otherwise
  • History of hypersensitivity to LCZ696, valsartan, or drugs of similar chemical classes.
  • Severe hypertension (grade 3 of WHO classification; msDBP ≥100 mmHg and/or msSBP ≥ 180 mmHg) at screening or at the end of the washout period.
  • History or evidence of a secondary form of hypertension,
  • Transient ischemic cerebral attack (TIA) during the 12 months prior to screening or any history of stroke.
  • History of myocardial infarction, coronary bypass surgery or percutaneous coronary intervention (PCI) during 12 month prior to screening.
  • Current or history of hypertensive retinopathy.
  • Previous or current diagnosis of heart failure (NYHA Class II-IV).
  • Clinically significant valvular heart disease at screening.

Other protocol defined inclusion/exclusion criteria may apply

05

Study design

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

Study arms

  • Experimental
    LCZ696 followed by Valsartan

    Period 1: LCZ696 400mg QD for 4 weeks then washout followed by Period 2: Valsartan 320mg QD for 4 weeks

    Drug: Valsartan · Drug: LCZ696

  • Experimental
    Valsartan followed by LCZ696

    Period 1: Valsartan 320mg QD for 4 weeks then washout followed by Period 2: LCZ696 400mg QD for 4 weeks

    Drug: Valsartan · Drug: LCZ696

Interventions

  • DrugValsartan

    Valsartan 320mg tablet once daily

  • DrugLCZ696

    LCZ696 400mg tablet once daily

06

What researchers measure

Primary outcomes

  1. Cumulative Sodium Excretion (Natriuresis) at Day 1

    Urine will be collected in fractions of 6 to 24 hours post-dose. From each fraction, a sample will be drawn for analysis of sodium Day 1

    Time frame: 0-6 and 0-24 hours on Day 1

Secondary outcomes

  1. Cumulative Sodium Excretion (Natriuresis) at Day 28

    Urine will be collected in fractions of 6 to 24 hours post-dose. From each fraction, a sample will be drawn for analysis of sodium Day 28

    Time frame: 0-6 and 0-24 hours on Day 28

  2. Urine Volume (Diuresis) Over Time

    Urine will be collected and volume measured in fractions of 0 to 6 hours and 0 to 24 hours Day-1, Day 1 and Day 28

    Time frame: Day -1, Day 1 & Day 28

  3. Seated Office Blood Pressure (BP) (Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)) Over Time

    Seated Office BP (systolic blood pressure (SBP) and diastolic blood pressure (DBP))measurements will be performed at trough(immediately prior to dosing at the clinic). Arterial BP readings will be made with an automated BP device.

    Time frame: Day-1, Day 14 and Day 28

  4. Mean Sitting Pulse Pressure (PP) Over Time

    Sitting mean pulse pressure rate was calculated between ambulatory SBP and DBP measurements

    Time frame: Day-1, Day 14 and Day 28

07

Results

Posted Oct 9, 2015

Participant flow

Period 1: 4 weeks treatment with LCZ696 400mg QD or Valsartan 320mg, 1-2 weeks wash-out, followed by period 2, 4 weeks treatment with Valsartan 320mg QD or LCZ696 400mg QD

Period 1
Participant flow — Period 1
MilestoneLCZ696 Followed by ValsartanValsartan Followed by LCZ696
Started3636
Completed3436
Not completed20
Withdrew: Adverse event10
Withdrew: Protocol deviation10
Period 2
Participant flow — Period 2
MilestoneLCZ696 Followed by ValsartanValsartan Followed by LCZ696
Started3436
Completed3035
Not completed41
Withdrew: Subject/guardian decision31
Withdrew: Non-compliance with study treatment10

Outcome measures

PrimaryCumulative Sodium Excretion (Natriuresis) at Day 1

Urine will be collected in fractions of 6 to 24 hours post-dose. From each fraction, a sample will be drawn for analysis of sodium Day 1

Time frame:
0-6 and 0-24 hours on Day 1
Reported as:
Mean · mmol
Cumulative Sodium Excretion (Natriuresis) at Day 1
mmolLCZ696 - ALLValsartan -ALL
0-6h (n=69,66)61.26 ± 31.16737.13 ± 20.761
0-24h (n=69,66)188.87 ± 74.458138.92 ± 58.905
SecondaryCumulative Sodium Excretion (Natriuresis) at Day 28

Urine will be collected in fractions of 6 to 24 hours post-dose. From each fraction, a sample will be drawn for analysis of sodium Day 28

Time frame:
0-6 and 0-24 hours on Day 28
Reported as:
Mean · mmol
Cumulative Sodium Excretion (Natriuresis) at Day 28
mmolLCZ696 - ALLValsartan - ALL
0-6h (n=69,66)39.30 ± 18.84144.57 ± 23.479
0-24h (n=69,66)144.71 ± 51.094153.82 ± 62.449
SecondaryUrine Volume (Diuresis) Over Time

Urine will be collected and volume measured in fractions of 0 to 6 hours and 0 to 24 hours Day-1, Day 1 and Day 28

Time frame:
Day -1, Day 1 & Day 28
Reported as:
Mean · mL
Urine Volume (Diuresis) Over Time
mLLCZ696 - ALLValsartan - ALL
Day -1 0-6h (n=70,67)855.1 ± 450.28806.2 ± 462.20
Day -1 0-24h (n=70,67)2752.8 ± 722.532756.2 ± 1010.86
Day 1 0-6h (n=70,67)1215.9 ± 475.57923.0 ± 443.65
Day 1 0-24h (n=70,67)3172.3 ± 957.702813.8 ± 930.05
Day 28 0-6h (n=69,66)948.8 ± 415.141042.7 ± 530.15
Day 28 0-24h (n=69,66)2820.0 ± 847.813000.2 ± 1139.75
SecondarySeated Office Blood Pressure (BP) (Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)) Over Time

Seated Office BP (systolic blood pressure (SBP) and diastolic blood pressure (DBP))measurements will be performed at trough(immediately prior to dosing at the clinic). Arterial BP readings will be made with an automated BP device.

Time frame:
Day-1, Day 14 and Day 28
Reported as:
Mean · mmHg
Seated Office Blood Pressure (BP) (Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)) Over Time
mmHgLCZ696 - ALLValsartan - ALL
Day -1 Sitting SBP (n=70,67)140.20 ± 13.691137.85 ± 12.703
Day 28 Sitting SBP (n=69,66)127.01 ± 12.723132.07 ± 15.195
Day 14 Sitting DBP (n=69,66)80.43 ± 7.80880.57 ± 9.246
Day 28 Sitting DBP (n=69,66)80.44 ± 7.84081.40 ± 9.276
Day 14 Sitting SBP (n=69,66)126.88 ± 12.451129.23 ± 12.784
Day -1 Sitting DBP (n=70,67)86.63 ± 8.95585.59 ± 9.299
SecondaryMean Sitting Pulse Pressure (PP) Over Time

Sitting mean pulse pressure rate was calculated between ambulatory SBP and DBP measurements

Time frame:
Day-1, Day 14 and Day 28
Reported as:
Mean · mmHg
Mean Sitting Pulse Pressure (PP) Over Time
mmHgLCZ696 - ALLValsartan - ALL
Day -1 Sitting mean PP (n=70,67)63.91 ± 8.39264.92 ± 10.086
Day 14 Sitting mean PP (n=69,66)71.91 ± 10.37069.61 ± 8.888
Day 28 Sitting mean PP (n=69,66)65.21 ± 8.99963.63 ± 8.843

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
LCZ696 400 mg QD—0/71 (0%)15/71 (21.1%)
Valsartan 320 mg QD—0/67 (0%)15/67 (22.4%)
Most frequent other events
Most frequent other events
EventLCZ696 400 mg QDValsartan 320 mg QD
DIZZINESSNervous system disorders5/715/67
NASOPHARYNGITISInfections and infestations2/714/67
HEADACHENervous system disorders1/714/67
COUGHRespiratory, thoracic and mediastinal disorders4/710/67
HAEMATURIARenal and urinary disorders3/712/67
BACK PAINMusculoskeletal and connective tissue disorders0/712/67
FLANK PAINMusculoskeletal and connective tissue disorders0/712/67
DRY MOUTHGastrointestinal disorders2/710/67
PYURIARenal and urinary disorders2/710/67

Baseline characteristics

Age, Continuous
Age, Continuous(years)LCZ696 Followed by ValsartanValsartan 320mgTotal
Mean55.7 ± 12.558.9 ± 7.557.3 ± 10.3
Sex: Female, Male
Sex: Female, Male(Participants)LCZ696 Followed by ValsartanValsartan 320mgTotal
Female131326
Male232346
08

Study locations

15 sites
  • Novartis Investigative Site
    Anaheim, California 92801, United States
  • Novartis Investigative Site
    Cypress, California 90630, United States
  • Novartis Investigative Site
    Glendale, California 91206, United States
  • Novartis Investigative Site
    Hong Kong, Shatin, NT, Hong Kong
  • Novartis Investigative Site
    Bucheon, Gyeonggi-do 424-717, Korea, Republic of
  • Novartis Investigative Site
    Koyang-si, Gyeonggi-do 410-773, Korea, Republic of
  • Novartis Investigative Site
    Seoul, Korea 110 744, Korea, Republic of
  • Novartis Investigative Site
    Seoul, 120-752, Korea, Republic of
  • Novartis Investigative Site
    Seoul, 152-703, Korea, Republic of
  • Novartis Investigative Site
    Singapore, 119228, Singapore
  • Novartis Investigative Site
    Singapore, 169609, Singapore
  • Novartis Investigative Site
    Taipei, Taiwan, ROC 112, Taiwan
  • Novartis Investigative Site
    Taichung, 40447, Taiwan
  • Novartis Investigative Site
    Taipei, 10002, Taiwan
  • Novartis Investigative Site
    Taipei, 114, Taiwan
09

References and documents

Publications

  • Wang TD, Tan RS, Lee HY, Ihm SH, Rhee MY, Tomlinson B, Pal P, Yang F, Hirschhorn E, Prescott MF, Hinder M, Langenickel TH. Effects of Sacubitril/Valsartan (LCZ696) on Natriuresis, Diuresis, Blood Pressures, and NT-proBNP in Salt-Sensitive Hypertension. Hypertension. 2017 Jan;69(1):32-41. doi: 10.1161/HYPERTENSIONAHA.116.08484. Epub 2016 Nov 14. PubMed 27849566 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01681576
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Sep 10, 2012
Start date
Aug 2012
Primary completion
Oct 2013
Completion
Oct 2013
Results posted
Oct 9, 2015
Last update
Nov 10, 2015

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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