Essential HypertensionPhase 2NCT01256411

A Long-term (12 Months) Safety, Tolerability and Efficacy Study of LCZ696 in Patients With Essential Hypertension

A Phase 2 study testing LCZ696, Amlodipine and Hydrochlorothiazide (HCTZ) in people with Essential Hypertension, run by Novartis Pharmaceuticals at 33 sites in 5 countries.

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

The purpose of this study is to assess the long-term safety, tolerability and efficacy of LCZ696. Read more about this study

Who is it for?: Any age
Conditions the study is for: Essential Hypertension
What is being tested?: LCZ696, Amlodipine and Hydrochlorothiazide (HCTZ)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 341 participants
Where: 33 sitesin 5 countries
Study dates: Nov 2010to Apr 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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients who have successfully completed protocol No. CLCZ696A2219 and who, as judged by the study investigator, are able to continue in the current study.
Ability to communicate and comply with all study requirements and demonstrate good medication compliance during CLCZ696A2219.

Who cannot join

Patients who did not complete CLCZ696A2219.
Presence of significant protocol violation in CLCZ696A2219.
Patients who are deemed to be unable to comply with the protocol by the investigator.
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

33 sites in 5 countries.

Country

City, postcode or hospital

33 sites in 5 countries

Japan13 sites

Novartis Investigative Site
Bunkyo-ku, Tokyo, 113-0031
Novartis Investigative Site
Chiyoda-ku, Tokyo, 100-0005
Novartis Investigative Site
Kiyose, Tokyo, 204-0021
Novartis Investigative Site
Kunitachi, Tokyo, 186-0001
Novartis Investigative Site
Minato-ku, Tokyo, 105-7390
Novartis Investigative Site
Minato-ku, Tokyo, 108-0075
Novartis Investigative Site
Ōta-ku, Tokyo, 143-0023
Novartis Investigative Site
Shimotsuke, Tochigi, 329-0498
Novartis Investigative Site
Shinagawa-ku, Tokyo, 141-0032
Novartis Investigative Site
Shinagawa-ku, Tokyo, 142-0053
Novartis Investigative Site
Shinagawa-ku, Tokyo, 142-0063
Novartis Investigative Site
Toshima-ku, Tokyo, 171-0021
Novartis Investigative Site
Yokohama, Kanagawa, 231-0023

Other trials in Japan

China6 sites

Novartis Investigative Site
Beijing, 100044
Novartis Investigative Site
Beijing, 100730
Novartis Investigative Site
Chongqing, Chongqing Municipality, 400042
Novartis Investigative Site
Hangzhou, Zhejiang, 310006
Novartis Investigative Site
Shijiazhuang, Hebei, 050000
Novartis Investigative Site
Tianjin, 300142

Other trials in China

South Korea6 sites

Novartis Investigative Site
Bucheon-si, Gyeonggi-do, 424-717
Novartis Investigative Site
Daegu, 705-703
Novartis Investigative Site
Koyang, Kyunggi, 410-719
Novartis Investigative Site
Seoul, Korea, 137-701
Novartis Investigative Site
Seoul, 150-950
Novartis Investigative Site
Seoul, 152-703

Other trials in South Korea

Taiwan5 sites

Novartis Investigative Site
Changhua, 500
Novartis Investigative Site
Taichung, Taiwan, 40447
Novartis Investigative Site
Taipei, Taiwan, 10002
Novartis Investigative Site
Taipei, Taiwan, 10449
Novartis Investigative Site
Taipei, Taiwan, 114

Other trials in Taiwan

Thailand3 sites

Novartis Investigative Site
Bangkok, 10400
Novartis Investigative Site
Bangkok, 10700
Novartis Investigative Site
Chiang Mai, 50200

Other trials in Thailand

About this study

Official title: An Open-label, Long-term Extension Study to Evaluate the Safety, Tolerability and Efficacy of 12 Months of LCZ696 Treatment in Patients With Essential Hypertension

The purpose of this study is to assess the long-term safety, tolerability and efficacy of LCZ696.

Conditions: Essential Hypertension
Being tested: LCZ696, Amlodipine, Hydrochlorothiazide (HCTZ)
Keywords: hypertension, blood pressure, LCZ696, dual-acting, neprilysin, nep inhibitor, vasopeptidase, angiotensin receptor, angiotensin receptor neprilysin inhibitor (ARNi)
Medical subject headings: Essential Hypertension, Hypertension

What participants receive

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

LCZ696Drug
Participants received LCZ696 200 mg as the starting dose with optional down titration to 100 mg for tolerance and optional up titration to 400 mg for adequate blood pressure control.
AmlodipineDrug
Optional add-on of amlodipine (5-10 mg) was allowed (as applicable per local country regulations) for adequate blood pressure control.
Hydrochlorothiazide (HCTZ)Drug
Optional add-on of hydrochlorothiazide (HCTZ) (12.5-25 mg) was allowed (as applicable per local country regulations) for adequate blood pressure control.

Study groups in NCT01256411
Study group	Role	What they receive
LCZ696	Experimental	Not described Receives: Drug: LCZ696; Drug: Amlodipine; Drug: Hydrochlorothiazide (HCTZ)

What is being measured

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

Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment)
Participants were monitored throughout the study for adverse events, serious adverse events and deaths.
Measured: Baseline to 12 months

Secondary outcomes (4)

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Maximum Treatment)
Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement.
Measured: Baseline, 12 months
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Mono or Combination Therapy)
Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement.
Measured: Baseline, 12 months
Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Maximum Treatment)
Blood pressure (BP) control is defined as BP <140/90 mmHg.
Measured: Baseline to 12 months
Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Mono or Combination Therapy)
Blood pressure (BP) control is defined as BP <140/90 mmHg.
Measured: Baseline to 12 months

Timeline

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

Nov 2010Apr 2012

First posted8 Dec 2010 (estimated)
Study startNov 2010
Primary completionApr 2012
Study completionApr 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 Essential 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 341 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01256411
Sponsor's protocol ID: CLCZ696A2219E1
Status last verified: Sep 2015
First submitted: 7 Dec 2010
Last updated: 21 Oct 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?

See locations

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All Essential Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Long-term Extension Study to Evaluate the Safety, Tolerability and Efficacy of 12 Months of LCZ696 Treatment in Patients With Essential Hypertension
ClinicalTrials.gov ID: NCT01256411
Acronym / sponsor ID: CLCZ696A2219E1
Conditions: Essential Hypertension
Keywords: hypertension, blood pressure, LCZ696, dual-acting, neprilysin, nep inhibitor, vasopeptidase, angiotensin receptor
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 341 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: Apr 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 8 Dec 2010 (estimated)
Results: Posted 21 Oct 2015

Clinical summary

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

The purpose of this study is to assess the long-term safety, tolerability and efficacy of LCZ696.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LCZ696	Experimental	Drug: LCZ696, Drug: Amlodipine, Drug: Hydrochlorothiazide (HCTZ)

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Patients who have successfully completed protocol No. CLCZ696A2219 and who, as judged by the study investigator, are able to continue in the current study.
Ability to communicate and comply with all study requirements and demonstrate good medication compliance during CLCZ696A2219.

Key exclusion criteria (4 listed)

Patients who did not complete CLCZ696A2219.
Presence of significant protocol violation in CLCZ696A2219.
Patients who are deemed to be unable to comply with the protocol by the investigator.
Other protocol-defined inclusion/exclusion criteria may apply

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
LCZ696Participants received LCZ696 200 mg as the starting dose with optional down titration to 100 mg for tolerance and optional up titration to 400 mg for adequate blood pressure control.	Drug	LCZ696
AmlodipineOptional add-on of amlodipine (5-10 mg) was allowed (as applicable per local country regulations) for adequate blood pressure control.	Drug	LCZ696
Hydrochlorothiazide (HCTZ)Optional add-on of hydrochlorothiazide (HCTZ) (12.5-25 mg) was allowed (as applicable per local country regulations) for adequate blood pressure control.	Drug	LCZ696

Primary outcome

Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment)
Time frame: Baseline to 12 months
Participants were monitored throughout the study for adverse events, serious adverse events and deaths.

4 secondary outcomes

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Maximum Treatment)
Time frame: Baseline, 12 months
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Mono or Combination Therapy)
Time frame: Baseline, 12 months
Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Maximum Treatment)
Time frame: Baseline to 12 months
Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Mono or Combination Therapy)
Time frame: Baseline to 12 months

Results and safety

Results posted to the registry on 21 Oct 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 200 mg	139	132
LCZ696 400 mg	89	79
LCZ606 400 mg/Amlodipine	109	105
LCZ696 400 mg/Amlodipine/HCTZ	4	4
LCZ696 Monotherapy	0	0
LCZ696 Combination Therapy	0	0

Primary outcome: Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment)

Time frame: Baseline to 12 months. Number. Unit: Participants

Measure	LCZ696 200 mg n = 340	LCZ696 400 mg n = 201	LCZ606 400 mg/Amlodipine n = 112	LCZ696 100 mg n = 12
Adverse events (serious and non-serious)	147	78	53	6
Seroius adverse events	10	2	0	1
Deaths	0	0	0	0

Population analysed: Actual extension treatment received: The participants are included in each treatment group for which they received treatment. For example, if a participant started on LCZ696 200 mg but was then down-titrated to LCZ696 100 mg, the participant was counted once in the LCZ696 100 mg group and once in the LCZ696 200 mg group.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LCZ696 100 mg	1 of 12 (8.3%)	6 of 12 (50%)	Not reported
LCZ696 200 mg	10 of 340 (2.9%)	77 of 340 (22.6%)	Not reported
LCZ696 400 mg	2 of 201 (1%)	39 of 201 (19.4%)	Not reported
LCZ696 400 mg/Aml	0 of 112 (0%)	32 of 112 (28.6%)	Not reported
LCZ696 400 mg/Aml/HCTZ	0 of 4 (0%)	0 of 4 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Essential Hypertension

Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
Hypertension (HTN), Hypertension
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
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Active, not recruiting
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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

33 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 LCZ696, Amlodipine and Hydrochlorothiazide (HCTZ) in people with Essential Hypertension, run by Novartis Pharmaceuticals at 33 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 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 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Japan, China, South Korea, Taiwan, Thailand. 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 21 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?

Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment) (time frame: Baseline to 12 months). 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 NCT01256411.

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 21 Oct 2015.