HypertensionPhase 2NCT01193101

Efficacy and Safety of LCZ696 Compared to Placebo in Patients With Essential Hypertension

A Phase 2 study testing LCZ696 in people with Hypertension, run by Novartis Pharmaceuticals at 34 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

This study is a phase 2 study in patients with essential hypertension. 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
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 389 participants
Where: 34 sitesin 5 countries
Study dates: Aug 2010to Apr 2011
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 must give written informed consent before any assessment is performed.
Patients with mild to moderate essential hypertension, untreated or currently taking antihypertensive therapy (mean sitting diastolic blood pressure ≥ 95 mmHg and < 110 mmHg, and mean sitting systolic blood pressure ≥ 140 mmHg and < 180 mmHg).
Patients must be willing and able to undergo ambulatory blood pressure monitoring for a 24-hr period at the beginning and the end of the 8-week treatment.
Patient must be able to communicate and comply with all study requirements and demonstrate good medication compliance.

Who cannot join

Patients with severe hypertension.
Patients with history of angioedema, drug-related or otherwise
Pregnant or nursing women
Women of child-bearing potential , who do not use adequate birth control methods
History or evidence of a secondary form of hypertension.
History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind, stroke, TIA, carotid artery stenosis, aortic aneurysm, or peripheral arterial disease.

Show all 10Show fewer

Diabetes mellitus.
Previous or current diagnosis of heart failure (NYHA Class II-IV).
Clinically significant valvular heart disease at the time of screening.
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

34 sites in 5 countries.

Country

City, postcode or hospital

34 sites in 5 countries

Japan14 sites

Novartis Investigative Site
Bunkyo-ku, Tokyo, 113-0031
Novartis Investigative Site
Bunkyo-ku, Tokyo, 113-8655
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, 400042
Novartis Investigative Site
Hangzhou, Zhejiang, 310009
Novartis Investigative Site
Shijiazhuang, Hebei, 050000
Novartis Investigative Site
Tianjin, Tianjin Municipality, 300142

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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: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Placebo After 8 Weeks Treatment in Patients With Essential Hypertension

This study is a phase 2 study in patients with essential hypertension.

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

What participants receive

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

LCZ696Drug
LCZ696
PlaceboDrug
matching placebo to LCZ696

Study groups in NCT01193101
Study group	Role	What they receive
LCZ696 100 mg	Experimental	LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week. Receives: Drug: LCZ696; Drug: Placebo
LCZ696 200 mg	Experimental	LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week. Receives: Drug: LCZ696; Drug: Placebo
LCZ696 400 mg	Experimental	LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week. Receives: Drug: LCZ696; Drug: Placebo
Placebo	Placebo comparator	Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week. Receives: Drug: Placebo

What is being measured

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

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement.
Measured: Baseline, 8 weeks

Secondary outcomes (12)

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement.
Measured: Baseline, 8 weeks
Change From Baseline in 24 Hour Mean Ambulatory DBP and SBP
Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. A negative change from baseline indicates improvement.
Measured: Baseline, 8 weeks
Change From Baseline in Daytime Mean Ambulatory DBP and SBP
Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Daytime mean SBP and DBP were the averages of the hourly means between 6 am and 10 pm. A negative change from baseline indicates improvement.
Measured: Baseline, 8 weeks
Change From Baseline in Nighttime Mean Ambulatory DBP and SBP
Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Nighttime mean SBP and DBP were the averages of the hourly means between 10 pm and 6 am. A negative change from baseline indicates improvement.
Measured: Baseline, 8 weeks
Change From Baseline in Mean Sitting Pulse Pressure
Mean sitting pulse pressure is the difference in msSBP and msDBP (msSBP - msDBP). A negative change from baseline indicates improvement.
Measured: Baseline, 8 weeks
Change From Baseline in Mean Ambulatory Pulse Pressure
Mean ambulatory pulse pressure is the difference in maSBP and maDBP (maSBP - maDBP). A negative change from baseline indicates improvement.
Measured: Baseline, 8 weeks
Number of Participants Who Achieved a Successful Response in msDBP
Successful response in msDBP is defined as msDBP <90 mmHg or a reduction ≥ 10 mmHg from baseline.
Measured: 8 weeks
Number of Participants Who Achieved a Successful Response in msSBP
Successful response in msSBP is defined as msSBP <140 mmHg or a reduction ≥ 20 mmHg from baseline.
Measured: 8 weeks
Number of Participants Who Achieved Successful BP Control
BP control is defined as BP < 140/90 mmHg.
Measured: 8 weeks
Trough to Post-dosing Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP
Trough to post-dosing hour ratio at each post-dosing hour = [trough LSM of LCZ696 - trough LSM of placebo]/[post-dosing hour LSM of LCZ696 - post-dosing hour LSM of placebo]
Measured: baseline, 8 weeks
Trough to Post-dosing Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP
Trough to post-dosing hour ratio at each post-dosing hour = [trough LSM of LCZ696 - trough LSM of placebo]/[post-dosing hour LSM of LCZ696 - post-dosing hour LSM of placebo]
Measured: baseline, 8 weeks
Change From Week 8 to Week 9 in msDBP and msSBP After Single-blind Placebo Withdrawal at Week 8
From week 8 to week 9, participants entered a single-blind placebo withdrawal period to assess the effect of LCZ696 on blood pressure following its discontinuation. Participants, who were randomized to the LCZ696 treatment groups, were discontinued from CLCZ696 at the end of week 8 and all 4 treatment groups received single-blind placebo for 1 week post week 8. A positive change from week 8 to week 9 indicates worsening.
Measured: 8 weeks, 9 weeks

Timeline

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

Aug 2010Apr 2011

First posted1 Sep 2010 (estimated)
Study startAug 2010
Primary completionApr 2011
Study completionApr 2011

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 (2)Papers the sponsor has linked to this study.
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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 389 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01193101
Sponsor's protocol ID: CLCZ696A2219
Status last verified: Jan 2016
First submitted: 26 Aug 2010
Last updated: 15 Feb 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Andersen MB, Simonsen U, Wehland M, Pietsch J, Grimm D. LCZ696 (Valsartan/Sacubitril)--A Possible New Treatment for Hypertension and Heart Failure. Basic Clin Pharmacol Toxicol. 2016 Jan;118(1):14-22. doi: 10.1111/bcpt.12453. Epub 2015 Sep 4.
PubMed 26280447
Kario K, Sun N, Chiang FT, Supasyndh O, Baek SH, Inubushi-Molessa A, Zhang Y, Gotou H, Lefkowitz M, Zhang J. Efficacy and safety of LCZ696, a first-in-class angiotensin receptor neprilysin inhibitor, in Asian patients with hypertension: a randomized, double-blind, placebo-controlled study. Hypertension. 2014 Apr;63(4):698-705. doi: 10.1161/HYPERTENSIONAHA.113.02002. Epub 2014 Jan 20.
PubMed 24446062

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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Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Placebo After 8 Weeks Treatment in Patients With Essential Hypertension
ClinicalTrials.gov ID: NCT01193101
Acronym / sponsor ID: CLCZ696A2219
Conditions: Hypertension
Keywords: hypertension, blood pressure, LCZ696, dual-acting, neprilysin, nep inhibitor, vasopeptidase, angiotensin receptor
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 389 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 1 Sep 2010 (estimated)
Results: Posted 19 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 is a phase 2 study in patients with essential hypertension.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
LCZ696 100 mg	Experimental	Drug: LCZ696, Drug: PlaceboLCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
LCZ696 200 mg	Experimental	Drug: LCZ696, Drug: PlaceboLCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
LCZ696 400 mg	Experimental	Drug: LCZ696, Drug: PlaceboLCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
Placebo	Placebo comparator	Drug: PlaceboPlacebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.

Who may qualify

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

Key inclusion criteria (4 listed)

Patients must give written informed consent before any assessment is performed.
Patients with mild to moderate essential hypertension, untreated or currently taking antihypertensive therapy (mean sitting diastolic blood pressure ≥ 95 mmHg and < 110 mmHg, and mean sitting systolic blood pressure ≥ 140 mmHg and < 180 mmHg).
Patients must be willing and able to undergo ambulatory blood pressure monitoring for a 24-hr period at the beginning and the end of the 8-week treatment.
Patient must be able to communicate and comply with all study requirements and demonstrate good medication compliance.

Key exclusion criteria (10 listed)

Patients with severe hypertension.
Patients with history of angioedema, drug-related or otherwise
Pregnant or nursing women
Women of child-bearing potential , who do not use adequate birth control methods
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
LCZ696LCZ696	Drug	LCZ696 100 mg, LCZ696 200 mg, LCZ696 400 mg
Placebomatching placebo to LCZ696	Drug	LCZ696 100 mg, LCZ696 200 mg, LCZ696 400 mg, Placebo

Primary outcome

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Time frame: Baseline, 8 weeks
Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement.

12 secondary outcomes

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Time frame: Baseline, 8 weeks
Change From Baseline in 24 Hour Mean Ambulatory DBP and SBP
Time frame: Baseline, 8 weeks
Change From Baseline in Daytime Mean Ambulatory DBP and SBP
Time frame: Baseline, 8 weeks
Change From Baseline in Nighttime Mean Ambulatory DBP and SBP
Time frame: Baseline, 8 weeks
Change From Baseline in Mean Sitting Pulse Pressure
Time frame: Baseline, 8 weeks
Change From Baseline in Mean Ambulatory Pulse Pressure
Time frame: Baseline, 8 weeks
Number of Participants Who Achieved a Successful Response in msDBP
Time frame: 8 weeks
Number of Participants Who Achieved a Successful Response in msSBP
Time frame: 8 weeks
Number of Participants Who Achieved Successful BP Control
Time frame: 8 weeks
Trough to Post-dosing Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP
Time frame: baseline, 8 weeks
Trough to Post-dosing Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP
Time frame: baseline, 8 weeks
Change From Week 8 to Week 9 in msDBP and msSBP After Single-blind Placebo Withdrawal at Week 8
Time frame: 8 weeks, 9 weeks

Results and safety

Results posted to the registry on 19 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	100	95
LCZ696 200 mg	101	94
LCZ696 400 mg	96	93
Placebo	92	80

Primary outcome: Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)

Time frame: Baseline, 8 weeks. Least squares mean (Standard Error). Unit: mmHg

Measure	LCZ696 100 mg n = 100	LCZ696 200 mg n = 98	LCZ696 400 mg n = 96	Placebo n = 92
Value	-11.53 (0.88)	-10.98 (0.89)	-12.45 (0.90)	-3.69 (0.92)

Population analysed: Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.

12 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 100 mg	0 of 100 (0%)	16 of 100 (16%)	Not reported
LCZ696 200 mg	1 of 101 (1%)	11 of 101 (10.9%)	Not reported
LCZ696 400 mg	2 of 96 (2.1%)	14 of 96 (14.6%)	Not reported
Placebo	0 of 92 (0%)	15 of 92 (16.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26280447Andersen MB, Simonsen U, Wehland M, Pietsch J, Grimm D. LCZ696 (Valsartan/Sacubitril)--A Possible New Treatment for Hypertension and Heart Failure. Basic Clin Pharmacol Toxicol. 2016 Jan;118(1):14-22. doi: 10.1111/bcpt.12453. Epub 2015 Sep 4.
Derived from this study: PubMed 24446062Kario K, Sun N, Chiang FT, Supasyndh O, Baek SH, Inubushi-Molessa A, Zhang Y, Gotou H, Lefkowitz M, Zhang J. Efficacy and safety of LCZ696, a first-in-class angiotensin receptor neprilysin inhibitor, in Asian patients with hypertension: a randomized, double-blind, placebo-controlled study. Hypertension. 2014 Apr;63(4):698-705. doi: 10.1161/HYPERTENSIONAHA.113.02002. Epub 2014 Jan 20.

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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

34 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 in people with Hypertension, run by Novartis Pharmaceuticals at 34 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 4 inclusion and 10 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 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 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. Some participants in this study may receive a placebo. 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 19 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?

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) (time frame: Baseline, 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 NCT01193101, which also lists 2 linked publications.

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 15 Feb 2016.