Salt-sensitive HypertensionPhase 2NCT01681576
Assessment of LCZ696 and Valsartan in Asian Patients With Salt-sensitive Hypertension
A Phase 2 study testing Valsartan and LCZ696 in people with Salt-sensitive Hypertension, run by Novartis Pharmaceuticals at 15 sites in 5 countries.
Trial summary
This study will evaluate the effect of LCZ696 and valsartan on natriuresis, diuresis, and blood pressure in salt-sensitive Asian hypertensive patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Salt-sensitive Hypertension
- What is being tested?
- Valsartan and LCZ696
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 15 sitesin 5 countries
- Study dates
- Aug 2012to Oct 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
South Korea5 sites
Novartis Investigative Site
Bucheon-si, Gyeonggi-do, 424-717
Novartis Investigative Site
Koyang-si, Gyeonggi-do, 410-773
Novartis Investigative Site
Seoul, Korea, 110 744
Novartis Investigative Site
Seoul, 120-752
Novartis Investigative Site
Seoul, 152-703
Taiwan4 sites
Novartis Investigative Site
Taichung, Taiwan, 40447
Novartis Investigative Site
Taipei, Taiwan, 10002
Novartis Investigative Site
Taipei, Taiwan, 114
Novartis Investigative Site
Taipei, Taiwan, ROC, 112
United States3 sites
Novartis Investigative Site
Anaheim, California, 92801
Novartis Investigative Site
Cypress, California, 90630
Novartis Investigative Site
Glendale, California, 91206
Singapore2 sites
Novartis Investigative Site
Singapore, Singapore, 119228
Novartis Investigative Site
Singapore, Singapore, 169609
About this study
Official title: A Randomized, Double-blind, Crossover Study to Assess the Effects of LCZ696 and Valsartan in Asian Patients With Salt-sensitive Hypertension
This study will evaluate the effect of LCZ696 and valsartan on natriuresis, diuresis, and blood pressure in salt-sensitive Asian hypertensive patients.
- Conditions
- Salt-sensitive Hypertension
- Being tested
- Valsartan, LCZ696
- Keywords
- hypertension, salt sensitivity, valsartan, LCZ696
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValsartanDrug
Valsartan 320mg tablet once daily
LCZ696Drug
LCZ696 400mg tablet once daily
| Study group | Role | What they receive |
|---|---|---|
| LCZ696 followed by Valsartan | Experimental | Period 1: LCZ696 400mg QD for 4 weeks then washout followed by Period 2: Valsartan 320mg QD for 4 weeks Receives: Drug: Valsartan; Drug: LCZ696 |
| Valsartan followed by LCZ696 | Experimental | Period 1: Valsartan 320mg QD for 4 weeks then washout followed by Period 2: LCZ696 400mg QD for 4 weeks Receives: Drug: Valsartan; Drug: LCZ696 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0-6 and 0-24 hours on Day 1
Secondary outcomes (4)
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
Measured: 0-6 and 0-24 hours on Day 28
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
Measured: Day -1, Day 1 & Day 28
Seated Office Blood Pressure (BP) (Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)) Over Time
Seated Office BP (systolic blood pressure (SBP) and diastolic blood pressure (DBP))measurements will be performed at trough(immediately prior to dosing at the clinic). Arterial BP readings will be made with an automated BP device.
Measured: Day-1, Day 14 and Day 28
Mean Sitting Pulse Pressure (PP) Over Time
Sitting mean pulse pressure rate was calculated between ambulatory SBP and DBP measurements
Measured: Day-1, Day 14 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Salt-sensitive HypertensionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681576
- Sponsor's protocol ID
- CLCZ696A2222
- Status last verified
- Oct 2015
- First submitted
- 30 Aug 2012
- Last updated
- 10 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Crossover Study to Assess the Effects of LCZ696 and Valsartan in Asian Patients With Salt-sensitive Hypertension
- ClinicalTrials.gov ID
- NCT01681576
- Acronym / sponsor ID
- CLCZ696A2222
- Conditions
- Salt-sensitive Hypertension
- Keywords
- hypertension, salt sensitivity, valsartan, LCZ696
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 10 Sep 2012 (estimated)
- Results
- Posted 9 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effect of LCZ696 and valsartan on natriuresis, diuresis, and blood pressure in salt-sensitive Asian hypertensive patients.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LCZ696 followed by Valsartan | Experimental | Drug: Valsartan, Drug: LCZ696Period 1: LCZ696 400mg QD for 4 weeks then washout followed by Period 2: Valsartan 320mg QD for 4 weeks |
| Valsartan followed by LCZ696 | Experimental | Drug: Valsartan, Drug: LCZ696Period 1: Valsartan 320mg QD for 4 weeks then washout followed by Period 2: LCZ696 400mg QD for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ValsartanValsartan 320mg tablet once daily | Drug | LCZ696 followed by Valsartan, Valsartan followed by LCZ696 |
| LCZ696LCZ696 400mg tablet once daily | Drug | LCZ696 followed by Valsartan, Valsartan followed by LCZ696 |
Primary outcome
Cumulative Sodium Excretion (Natriuresis) at Day 1
Time frame: 0-6 and 0-24 hours on 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
4 secondary outcomes
Cumulative Sodium Excretion (Natriuresis) at Day 28
Time frame: 0-6 and 0-24 hours on Day 28
Urine Volume (Diuresis) Over Time
Time frame: Day -1, Day 1 & Day 28
Seated Office Blood Pressure (BP) (Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)) Over Time
Time frame: Day-1, Day 14 and Day 28
Mean Sitting Pulse Pressure (PP) Over Time
Time frame: Day-1, Day 14 and Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27849566Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Valsartan and LCZ696 in people with Salt-sensitive Hypertension, run by Novartis Pharmaceuticals at 15 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in South Korea, Taiwan, United States, Singapore, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Sodium Excretion (Natriuresis) at Day 1 (time frame: 0-6 and 0-24 hours on Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01681576, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2015.