Hypertension With Renal DysfunctionPhase 3NCT01593787

Safety and Tolerability and Efficacy of LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction

A Phase 3 study testing LCZ696 in people with Hypertension With Renal Dysfunction, run by Novartis Pharmaceuticals at 13 sites in Japan.

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

This study assessed the safety, tolerability, and efficacy of LCZ696 in hypertensive patients with renal dysfunction. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Hypertension With Renal Dysfunction
What is being tested?: LCZ696
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 13 sitesJapan
Study dates: May 2012to Mar 2013
Phase: Phase 3
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Renal findings: Hypertensive patients with renal dysfunction and stable renal condition at least 4 weeks before screening visit.
Satisfy office msSBP ≥140 mmHg and <180 mmHg at baseline.

Who cannot join

Patients show msDBP ≥110 mmHg and/or msSBP ≥180 mmHg.
History of angioedema, drug-related or otherwise, as reported by the patient.
Any other following renal disorder:
Patients show eGFR < 15mL/min/1.73m^2
Patients on dialysis
Patients who previously entered a LCZ696 study and had been randomized or enrolled into the active drug treatment epoch.
Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

Japan13 sites

Novartis Investigative Site
Aira, Kagoshima-ken, 899-5431
Novartis Investigative Site
Fujimino, Saitama, 356-0053
Novartis Investigative Site
Hachiōji, Tokyo, 192-0918
Novartis Investigative Site
Kawasaki, Kanagawa, 210-0852
Novartis Investigative Site
Kurashiki, Okayama-ken, 701-0192
Novartis Investigative Site
Minato-ku, Tokyo, 108-0075
Novartis Investigative Site
Osaka, Osaka, 536-0008
Novartis Investigative Site
Sapporo, Hokkaido, 003-0026
Novartis Investigative Site
Sapporo, Hokkaido, 003-0825
Novartis Investigative Site
Sapporo, Hokkaido, 063-0842
Novartis Investigative Site
Sendai, Miyagi, 980-8574
Novartis Investigative Site
Shinagawa-ku, Tokyo, 141-0032
Novartis Investigative Site
Yokohama, Kanagawa, 231-0023

Other trials in Japan

About this study

Official title: A Multi-center, Open Label Study for Evaluation of the Safety, Tolerability and Efficacy of 8-week Treatment With LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction

This study assessed the safety, tolerability, and efficacy of LCZ696 in hypertensive patients with renal dysfunction.

Conditions: Hypertension With Renal Dysfunction
Being tested: LCZ696
Keywords: Hypertension, Renal dysfunction, LCZ696
Medical subject headings: Hypertension, Renal Insufficiency

What participants receive

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

LCZ696Drug
100 mg, 200 mg, 400 mg tablets.

Study groups in NCT01593787
Study group	Role	What they receive
LCZ696 100 mg	Experimental	All participants were started on LCZ696 100 mg once daily on day 1. Receives: Drug: LCZ696
LCZ696 200 mg	Experimental	All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg. Receives: Drug: LCZ696
LCZ696 400 mg	Experimental	All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg. Receives: Drug: LCZ696

What is being measured

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

Percentage of Participants With Reported Adverse Events (Total Adverse Events, Serious Adverse Events and Death)
Percentage of patients with total adverse events, serious adverse events and death were reported.
Measured: 8 weeks

Secondary outcomes (7)

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 8
Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurements.
Measured: baseline, 8 weeks
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 8
Measured: baseline, 8 weeks
Percentage of Participants Achieving a Successful BP Control at Week 8
A successful BP control was defined as msSBP <130 mmHg and msDBP <80 mmHg
Measured: 8 weeks
Percentage of Participants Achieving SBP Control at Week 8
SBP control was defined as msSBP <130 mmHg.
Measured: 8 weeks
Percentage of Participants Achieving DBP Control at Week 8
DBP control was defined as msDBP <80 mmHg.
Measured: 8 weeks
Percentage of Participants Achieving a Successful Response Rate in msSBP at Week 8
Successful response rate was defined as msSBP <130 mmHg or a reduction of ≥20 mmHg from baseline
Measured: 8 weeks
Percentage of Participants Achieving a Successful Response Rate in msDBP at Week 8
Successful response rate was defined as msDBP <80 mmHg or a reduction of ≥10 mmHg from baseline.
Measured: 8 weeks

Timeline

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

May 2012Mar 2013

First posted8 May 2012 (estimated)
Study startMay 2012
Primary completionMar 2013
Study completionMar 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 Hypertension With Renal DysfunctionStudies 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 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01593787
Sponsor's protocol ID: CLCZ696A1304
Status last verified: Aug 2015
First submitted: 30 Apr 2012
Last updated: 13 Aug 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Ito S, Satoh M, Tamaki Y, Gotou H, Charney A, Okino N, Akahori M, Zhang J. Safety and efficacy of LCZ696, a first-in-class angiotensin receptor neprilysin inhibitor, in Japanese patients with hypertension and renal dysfunction. Hypertens Res. 2015 Apr;38(4):269-75. doi: 10.1038/hr.2015.1. Epub 2015 Feb 19.
PubMed 25693859

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?

See locations

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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
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A Study of Clazakizumab (LY5724886) in Adults With Elevated hsCRP and at Increased Risk for Cardiovascular Event
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Autonomic and Renal Contributions to Hypertension With ADT
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All Hypertension With Renal Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Open Label Study for Evaluation of the Safety, Tolerability and Efficacy of 8-week Treatment With LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction
ClinicalTrials.gov ID: NCT01593787
Acronym / sponsor ID: CLCZ696A1304
Conditions: Hypertension With Renal Dysfunction
Keywords: Hypertension, Renal dysfunction, LCZ696
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: May 2012
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 8 May 2012 (estimated)
Results: Posted 13 Aug 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 assessed the safety, tolerability, and efficacy of LCZ696 in hypertensive patients with renal dysfunction.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
LCZ696 100 mg	Experimental	Drug: LCZ696All participants were started on LCZ696 100 mg once daily on day 1.
LCZ696 200 mg	Experimental	Drug: LCZ696All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
LCZ696 400 mg	Experimental	Drug: LCZ696All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Renal findings: Hypertensive patients with renal dysfunction and stable renal condition at least 4 weeks before screening visit.
Satisfy office msSBP ≥140 mmHg and <180 mmHg at baseline.

Key exclusion criteria (7 listed)

Patients show msDBP ≥110 mmHg and/or msSBP ≥180 mmHg.
History of angioedema, drug-related or otherwise, as reported by the patient.
Any other following renal disorder:
Patients show eGFR < 15mL/min/1.73m^2
Patients on dialysis

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
LCZ696100 mg, 200 mg, 400 mg tablets.	Drug	LCZ696 100 mg, LCZ696 200 mg, LCZ696 400 mg

Primary outcome

Percentage of Participants With Reported Adverse Events (Total Adverse Events, Serious Adverse Events and Death)
Time frame: 8 weeks
Percentage of patients with total adverse events, serious adverse events and death were reported.

7 secondary outcomes

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 8
Time frame: baseline, 8 weeks
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 8
Time frame: baseline, 8 weeks
Percentage of Participants Achieving a Successful BP Control at Week 8
Time frame: 8 weeks
Percentage of Participants Achieving SBP Control at Week 8
Time frame: 8 weeks
Percentage of Participants Achieving DBP Control at Week 8
Time frame: 8 weeks
Percentage of Participants Achieving a Successful Response Rate in msSBP at Week 8
Time frame: 8 weeks
Percentage of Participants Achieving a Successful Response Rate in msDBP at Week 8
Time frame: 8 weeks

Results and safety

Results posted to the registry on 13 Aug 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 100 mg	6	5
LCZ696 200 mg	8	8
LCZ696 400 mg	18	18

Primary outcome: Percentage of Participants With Reported Adverse Events (Total Adverse Events, Serious Adverse Events and Death)

Time frame: 8 weeks. Number. Unit: Percentage of participants

Measure	LCZ696 100 mg n = 32	LCZ696 400 mg n = 18	Total LCZ696 n = 32
Adverse events (serious and non-serious)	31.3	27.8	43.8
Serious Adverse Events	0	0	0
Deaths	0	0	0

Population analysed: Safety Set: This set included all participants who received at least one dose of LCZ696. AE analysis was determined by actual treatment, i.e. the LCZ696 dose on the day in which the corresponding summary was targeting. Other safety analysis was determined by the maximum treatment.

7 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
LCZ 100 mg	0 of 32 (0%)	5 of 32 (15.6%)	Not reported
LCZ 400 mg	0 of 18 (0%)	5 of 18 (27.8%)	Not reported
Total LCZ696	0 of 32 (0%)	9 of 32 (28.1%)	Not reported
LCZ 200 mg	0 of 26 (0%)	0 of 26 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25693859Ito S, Satoh M, Tamaki Y, Gotou H, Charney A, Okino N, Akahori M, Zhang J. Safety and efficacy of LCZ696, a first-in-class angiotensin receptor neprilysin inhibitor, in Japanese patients with hypertension and renal dysfunction. Hypertens Res. 2015 Apr;38(4):269-75. doi: 10.1038/hr.2015.1. Epub 2015 Feb 19.

Related trials for Hypertension With Renal Dysfunction

Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
RecruitingPhase 2
A Study of Clazakizumab (LY5724886) in Adults With Elevated hsCRP and at Increased Risk for Cardiovascular Event
Atherosclerosis, Cardiovascular Disease
RecruitingObservational study
Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
Arterial Hypertension, Chronic Kidney Disease, Primary Aldosteronism
RecruitingPhase 4
Autonomic and Renal Contributions to Hypertension With ADT
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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LCZ696 in people with Hypertension With Renal Dysfunction, run by Novartis Pharmaceuticals at 13 sites in Japan.

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 7 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 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 13 Aug 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?

Percentage of Participants With Reported Adverse Events (Total Adverse Events, Serious Adverse Events and Death) (time frame: 8 weeks). 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 NCT01593787, 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 13 Aug 2015.