HypertensionPhase 2NCT01353508

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

A Phase 2 study testing LCZ696 and Valsartan in people with Hypertension, run by Novartis Pharmaceuticals at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Assess mechanism of action of LCZ696 related to sodium excretion. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
What is being tested?: LCZ696 and Valsartan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteRussia
Study dates: Mar 2011to Aug 2012
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

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Russia1 site

Novartis Investigative Site
Moscow, 117198

Other trials in Russia

About this study

Official title: A Randomized, Double-blind, Controlled, Crossover Study to Evaluate the Sodium Excretion of LCZ696 in Patients With Stable Heart Failure, in Patients With Hypertension, and in Healthy Volunteers

Assess mechanism of action of LCZ696 related to sodium excretion.

Conditions: Hypertension
Being tested: LCZ696, Valsartan
Keywords: Sodium excretion,, LCZ696
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LCZ696Drug
200 mg and 400 mg tablets
ValsartanDrug
160 mg tablets

Study groups in NCT01353508
Study group	Role	What they receive
LCZ696 to Valsartan - Heart Failure (HF) cohort	Experimental	Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2. Receives: Drug: LCZ696; Drug: Valsartan
Valsartan to LCZ696 - HF Cohort	Experimental	Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2. Receives: Drug: LCZ696; Drug: Valsartan
LCZ696 to Valsartan - Hypertension (HTN) cohort	Experimental	Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2. Receives: Drug: LCZ696; Drug: Valsartan
Valsartan to LCZ696 - HTN cohort	Experimental	Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2. Receives: Drug: LCZ696; Drug: Valsartan

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: day 1
Cumulative 7-day Urinary Sodium Excretion
Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, sodium concentration was measured. The measure type used for this outcome measure (OM) was Geometric Least square Means (LSM).
Measured: 7 day-cummulative (days 1 through 7)

Secondary outcomes (17)

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.
Measured: day 1
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.
Measured: 7-day cumulative (days 1 through 7)
Urinary Cyclic Guanosine Monophosphate (cGMP) Excretion Over 24 Hours
cGMP was analyzed at a central laboratory. The measure type used for this OM was Geometric LSM.
Measured: day 1, day 6, day 7
Percent Change From Baseline in Plasma Mid-regional Pro-atrial Natriuretic Peptide (MR-proANP) Biomarker
MR-proANP was analyzed at a central laboratory.
Measured: 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 2, 4, 6 and 12 hours post dose on day 7
Percent Change From Baseline in Brain Natriuretic Peptide (BNP) Biomarker
BNP was analyzed at a central laboratory.
Measured: 0.5, 1, 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7
Percent Change From Baseline in Mid-regional Pro-adrenomedullin (MR-proADM) Biomarker
MR-proADM was analyzed at a central laboratory.
Measured: 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7
Percent Change From Baseline in C-type Natriuretic Peptide (proCNP) Biomarker
ProCNP was analyzed at a central laboratory.
Measured: 2, 4, 6, 8 and 12 hours post dose on day 1; day 2; 0, 4, 6, 8 and 12 hours post dose on day 7
Percent Change From Baseline in C-terminal-proendothelin-1 (CT-proET-1) Biomarker
CT-proET-1 was analyzed at a central laboratory.
Measured: 12 hours post dose on day 1; 24 hours post dose on day 2; 0 and 12 hours post dose on day 7
Percent Change From Baseline in N-terminal-proBNP (NT-proBNP) Biomarker
NT-proBNP was analyzed at a central laboratory.
Measured: 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7
Percent Change From Baseline in Aldosterone Biomarker
Aldosterone was analyzed at a central laboratory.
Measured: 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 6 and 12 hours post dose on day 7
Percent Change From Baseline in Urinary Electrolyte Excretion (Sodium, Potassium, Chloride and Calcium)
Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, sodium, potassium, albumin and calcium were measured.
Measured: 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7
Percent Change From Baseline in Blood Plasma Creatinine
Blood plasma creatinine was analyzed at a central laboratory.
Measured: 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7
Glomerular Filtration Rate (GFR) Over Time
GFR was used as a measure of renal function.
Measured: 0, 2, 4 and 6 hours post dose on day 1; 0, 2, 4 and 6 hours post dose on day 7
Renal Blood Flow (RBF) Over Time
RBF was used as a measure of renal function.
Measured: 0, 2, 4 and 6 hours post dose on day 1; 0, 2, 4 and 6 hours post dose on day 7
Supine Systolic Blood Pressure
Systolic blood pressure measurements were taken.
Measured: 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 1; day 2; 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 7
Supine Diastolic Blood Pressure
Diastolic blood pressure measurements were taken.
Measured: 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 1; day 2; 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 7
Supine Pulse Rate
Pulse rate measurements were taken.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2011Aug 2012

First posted13 May 2011 (estimated)
Study startMar 2011
Primary completionAug 2012
Study completionAug 2012

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.
Other trials for 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01353508
Sponsor's protocol ID: CLCZ696B2223
Status last verified: Oct 2015
First submitted: 16 Mar 2011
Last updated: 23 Nov 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Controlled, Crossover Study to Evaluate the Sodium Excretion of LCZ696 in Patients With Stable Heart Failure, in Patients With Hypertension, and in Healthy Volunteers
ClinicalTrials.gov ID: NCT01353508
Acronym / sponsor ID: CLCZ696B2223
Conditions: Hypertension
Keywords: Sodium excretion,, LCZ696
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Mar 2011
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 13 May 2011 (estimated)
Results: Posted 23 Nov 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Assess mechanism of action of LCZ696 related to sodium excretion.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
LCZ696 to Valsartan - Heart Failure (HF) cohort	Experimental	Drug: LCZ696, Drug: ValsartanParticipants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
Valsartan to LCZ696 - HF Cohort	Experimental	Drug: LCZ696, Drug: ValsartanParticipants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
LCZ696 to Valsartan - Hypertension (HTN) cohort	Experimental	Drug: LCZ696, Drug: ValsartanParticipants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
Valsartan to LCZ696 - HTN cohort	Experimental	Drug: LCZ696, Drug: ValsartanParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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

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
LCZ696200 mg and 400 mg tablets	Drug	LCZ696 to Valsartan - Heart Failure (HF) cohort, LCZ696 to Valsartan - Hypertension (HTN) cohort, Valsartan to LCZ696 - HF Cohort, Valsartan to LCZ696 - HTN cohort
Valsartan160 mg tablets	Drug	LCZ696 to Valsartan - Heart Failure (HF) cohort, LCZ696 to Valsartan - Hypertension (HTN) cohort, Valsartan to LCZ696 - HF Cohort, Valsartan to LCZ696 - HTN cohort

Primary outcome

24-hour Urinary Sodium Excretion
Time frame: day 1
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).
Cumulative 7-day Urinary Sodium Excretion
Time frame: 7 day-cummulative (days 1 through 7)
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).

17 secondary outcomes

24-hour Diuresis
Time frame: day 1
7-day Cumulative Diuresis
Time frame: 7-day cumulative (days 1 through 7)
Urinary Cyclic Guanosine Monophosphate (cGMP) Excretion Over 24 Hours
Time frame: day 1, day 6, day 7
Percent Change From Baseline in Plasma Mid-regional Pro-atrial Natriuretic Peptide (MR-proANP) Biomarker
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
Percent Change From Baseline in Brain Natriuretic Peptide (BNP) Biomarker
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
Percent Change From Baseline in Mid-regional Pro-adrenomedullin (MR-proADM) Biomarker
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
Percent Change From Baseline in C-type Natriuretic Peptide (proCNP) Biomarker
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
Percent Change From Baseline in C-terminal-proendothelin-1 (CT-proET-1) Biomarker
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
Percent Change From Baseline in N-terminal-proBNP (NT-proBNP) Biomarker
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
Percent Change From Baseline in Aldosterone Biomarker
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
Percent Change From Baseline in Urinary Electrolyte Excretion (Sodium, Potassium, Chloride and Calcium)
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
Percent Change From Baseline in Blood Plasma Creatinine
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
Glomerular Filtration Rate (GFR) Over Time
Time frame: 0, 2, 4 and 6 hours post dose on day 1; 0, 2, 4 and 6 hours post dose on day 7
Renal Blood Flow (RBF) Over Time
Time frame: 0, 2, 4 and 6 hours post dose on day 1; 0, 2, 4 and 6 hours post dose on day 7
Supine Systolic Blood Pressure
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
Supine Diastolic Blood Pressure
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
Supine Pulse Rate
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

Results and safety

Results posted to the registry on 23 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LCZ696 to Valsartan - Heart Failure (HF) Cohort	8	8
Valsartan to LCZ696 - HF Cohort	8	8
LCZ696 to Valsartan - Hypertension (HTN) Cohort	8	8
Valsartan to LCZ696 - HTN Cohort	8	7

Primary outcome: 24-hour Urinary Sodium Excretion

Time frame: day 1. Least squares mean (95% Confidence Interval). Unit: mmol/24 hours

Measure	LCZ696 - Heart Failure (HF) Cohort n = 16	Valsartan - HF Cohort n = 16	LCZ696 - Hypertension (HTN) Cohort n = 16	Valsartan - HTN Cohort n = 16
Value	220.58 (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)

Population analysed: The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.

Primary outcome: Cumulative 7-day Urinary Sodium Excretion

Time frame: 7 day-cummulative (days 1 through 7). Least squares mean (95% Confidence Interval). Unit: mmol/7 days

Measure	LCZ696 - Heart Failure (HF) Cohort n = 16	Valsartan - HF Cohort n = 16	LCZ696 - Hypertension (HTN) Cohort n = 16	Valsartan - HTN Cohort n = 16
Value	1020.57 (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)

Population analysed: The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.

17 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LCZ696 - Heart Failure (HF) Cohort	0 of 16 (0%)	3 of 16 (18.8%)	Not reported
Valsartan - HF Cohort	0 of 15 (0%)	1 of 15 (6.7%)	Not reported
LCZ696 - Hypertension (HTN) Cohort	0 of 15 (0%)	1 of 15 (6.7%)	Not reported
Valsartan - HTN Cohort	0 of 16 (0%)	3 of 16 (18.8%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LCZ696 and Valsartan in people with Hypertension, run by Novartis Pharmaceuticals at 1 site in Russia.

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 2 inclusion and 4 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 23 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 1 site in Russia. 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 23 Nov 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?

24-hour Urinary Sodium Excretion (time frame: day 1). The study lists 2 primary outcomes in all. 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 NCT01353508.

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 23 Nov 2015.